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ALBumin Italian Outcome Septic Shock-BALANCED Trial (ALBIOSS-BALANCED) (ALBIOSS-BAL)

Primary Purpose

Septic Shock

Status
Unknown status
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Albumin
Balanced
Sponsored by
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock focused on measuring Septic Shock, Albumin, Balanced crystalloids

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with septic shock if they meet the two following criteria:

  1. Presence of an infection (known or suspected) in at least one site:

    1. Lung
    2. Abdomen
    3. Urinary tract
    4. Others (blood, skin and soft tissues, central nervous system, bones and joints, cardiac system, reproductive organs).
  2. Presence of a severe and acute, sepsis-related cardiovascular failure (as assessed by the SOFA score - see Annex 1), requiring vasopressor to maintain mean arterial pressure >=65 mmHg, despite adequate volume resuscitation a) Cardiovascular SOFA score > 2 (3 or 4) If the patient is unable to provide informed consent, she/he can be included in the trial provided that the requirements of ongoing laws are fulfilled; details on this approach are provided in the protocol, par 11.1 and related Annex 3. The patient will be informed about having been included in a clinical trial, as soon as she/he will regain consciousness.

Exclusion Criteria:

  1. Age < 18 years
  2. Moribund state
  3. Known or suspected adverse reaction to albumin administration
  4. Septic shock in patients with traumatic brain injury or a clinically active cerebral lesion (known or suspected)
  5. Severe congestive heart failure (NYHA III and IV classes)
  6. Clinical situations in which the use of albumin is known or supposed to be clinically beneficial (hepatic cirrhosis with ascites, malabsorption syndrome or protein-losing enteropathy, nephrotic syndrome, burns)
  7. More than 24 hours after the onset of septic shock
  8. Religious objection to the administration of human blood products
  9. Presence of chronic end-stage renal disease
  10. Severe hyperkalemia
  11. Enrollment in other experimental interventional studies

Sites / Locations

  • Ospedali Riuniti di AnconaRecruiting
  • Ospedale Regionale Umberto Parini
  • AOU Policlinico di Bari
  • ASST Papa Giovanni XXIIIRecruiting
  • ASST BG Est - Ospedale BologniniRecruiting
  • AST BG Ovest - PO TreviglioRecruiting
  • Policlinico Sant'Orsola-Malpighi
  • AOU Mater Domini Catanzaro
  • Azienda Ospedaliero - Universitaria di Ferrara - Arcispedale Sant'AnnaRecruiting
  • Ospedali Riuniti di Foggia
  • Ospedale del MugelloRecruiting
  • Ospedale San Giuseppe
  • AOU CareggiRecruiting
  • Ente Ospedaliero Ospedali Galliera
  • Ospedale Policlinico San Martino
  • Ospedale Colline dell'AlbegnaRecruiting
  • ASST Lecco AO Manzoni
  • Ospedale Vito Fazzi
  • Presidio Ospedaliero di DesioRecruiting
  • Azienda Ospedaliera S. GerardoRecruiting
  • ASST Nord Milano - Ospedale BassiniRecruiting
  • ASST Ovest MilanoRecruiting
  • Fondazione IRCCS Ca' Granda - Ospedale Maggiore PoliclinicoRecruiting
  • ASST Santi Paolo e Carlo, Ospedale San Paolo
  • ASST Fatebenefratelli - Sacco P.O. Sacco
  • ASST Grande Ospedale Metropolitano NiguardaRecruiting
  • IRCCS Policlinico San Donato
  • Azienda Ospedaliero-Universitaria di Modena, Policlinico di ModenaRecruiting
  • AOU Policlinico Paolo GiacconeRecruiting
  • ISMETTRecruiting
  • AOU Pisana
  • As FO Azienda sanitaria Friuli Occidentale
  • Azienda Ospedaliero - Universitaria di Parma
  • Fondazione IRCCS Policlinico San MatteoRecruiting
  • IRCCS ASMN Reggio EmiliaRecruiting
  • Fondazione Policlinico Universitario A. Gemelli, Università Cattolica del Sacro CuoreRecruiting
  • Azienda Ospedaliera Universitaria Sassari
  • Ospedale Santa Chiara
  • Ospedale Santa Croce
  • Azienda Ospedaliero - Universitaria S. Luigi GonzagaRecruiting
  • AOU Città della Salute e della Scienza di TorinoRecruiting
  • ASU Giuliano Isontina
  • Azienda Sanitaria Universitaria Integrata di UdineRecruiting
  • Ospedale Galmarini Tradate
  • Ospedale di Circolo e Fondazione MacchiRecruiting
  • Azienda Ospedaliera Universitaria Integrata di Verona
  • Ospedale SS. Antonio e Biagio e Cesare ArrigoRecruiting
  • Ospedale San Carlo Borromeo
  • Azienda Ospedaliero-Universitaria Sant'Andrea

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Albumin + Balanced

Albumin + Saline

Balanced

Saline

Arm Description

Human Albumin In parallel with fluid administration for volume resuscitation, patients will receive 400 ml of 20% albumin solution both at randomization (D0) and at day 1 (D1). Subsequently, from day 2 (D2) until day 90 (D90) or ICU discharge (whichever comes first), 20% albumin will be administered on a daily basis, to maintain serum albumin concentration equal to or greater than 30 g/L, based upon serum albumin determination. Balanced crystalloid solutions According to the preference and the standard use of the participating center: Ringer Lactate Ringer Acetate Crystalsol

Human Albumin In parallel with fluid administration for volume resuscitation, patients will receive 400 ml of 20% albumin solution both at randomization (D0) and at day 1 (D1). Subsequently, from day 2 (D2) until day 90 (D90) or ICU discharge (whichever comes first), 20% albumin will be administered on a daily basis, to maintain serum albumin concentration equal to or greater than 30 g/L, based upon serum albumin determination. Normal Saline Na+ 154 mEq/L, Cl- 154 mEq/L (0.9% NaCl).

Balanced crystalloid solutions (Ringer Lactate, Ringer Acetate, Crystalsol)

Normal Saline Na+ 154 mEq/L, Cl- 154 mEq/L (0.9% NaCl).

Outcomes

Primary Outcome Measures

All-cause 90-day mortality
All-cause death from randomization to 90 days
Combined co-primary endpoint
The composite of all-cause death from randomization to 90 days and new occurrence of acute kidney injury (AKI).

Secondary Outcome Measures

ICU mortality
All-cause death occurring in Intensive Care Unit (ICU)
In-hospital mortality
All-cause death occurring during hospital stay
1-year mortality
All-cause death from randomization to 1 year
SOFA score
Severity and incidence of organ failures, as assessed by the Sequential Organ Failure Assessment (SOFA) score. SOFA score is used to determine the extent of organ function in a patient while in the intensive care unit. The score is based on 6 different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems. The scale of each score ranges from 0 (no dysfunction) to 4 (maximal dysfunction). The 6 scores are then added up to provide a global score: the highest the value, the worst the condition of the patient.
Incidence of AKI
Assessed by the Kidney Disease Improving Global Outcome (KDIGO) criteria as any of the following: (1) increase in serum creatinine >=0.3 mg/dl (26.5 mmol/l) within 48 hours; or (2) increase in SCr to >=1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or (3) urine volume <0.5 ml/kg/h for 6 hours.
RRT
First use of Renal Replacement Therapy (RRT) during ICU stay
Need for vasopressors
Duration of the need for vasopressors during ICU stay
Mechanical ventilation
Duration of mechanical ventilation during ICU stay
Secondary infections in ICU
Incidence of secondary-acquired infections during ICU stay
Duration of stay in ICU
Duration expressed as number of days spent in ICU
Duration of stay in hospital
Duration expressed as number of days spent in hospital

Full Information

First Posted
August 3, 2018
Last Updated
April 22, 2021
Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Collaborators
Istituto Di Ricerche Farmacologiche Mario Negri
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1. Study Identification

Unique Protocol Identification Number
NCT03654001
Brief Title
ALBumin Italian Outcome Septic Shock-BALANCED Trial (ALBIOSS-BALANCED)
Acronym
ALBIOSS-BAL
Official Title
Efficacy of Albumin Replacement and Balanced Solution in Patients With Septic Shock (the ALBIOSS-BALANCED Trial): a 2-by-2 Factorial, Investigator-initiated, Open- Label, Multicenter, Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 7, 2019 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
February 28, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Collaborators
Istituto Di Ricerche Farmacologiche Mario Negri

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Septic shock is a devastating condition often observed in ICU. It is characterized by pro-inflammatory and immune responses, organ failures, high incidence of AKI and lethality. Fluid resuscitation is pivotal as supportive therapy. At present, there are no effective therapies to improve survival of such clinical condition, often characterized by a mortality as high as 40% during the first 90 days from diagnosis. This project proposes a large 2-by-2 factorial randomized clinical trial testing the efficacy of albumin and the low- chloride balanced crystalloid solutions (either Ringer Lactate, Ringer Acetate, or Crystalsol - BAL) in septic shock. The investigators have recently concluded a multicenter, randomized trial, the ALBIOS trial, in which, in a post-hoc analysis, albumin, in addition to crystalloids, reduced 90-day mortality in patients with septic shock, as compared to crystalloids alone (Caironi P et al, 2014). Crystalloids with supra-physiological chloride content may deteriorate renal perfusion, increasing the risk of acute kidney injury (AKI) and mortality.
Detailed Description
The project will consist of a 2-by-2 factorial, investigator-initiated, open-label, multicenter, randomized, controlled trial, with PROBE design (Prospective Randomized Open Trial with Blinded Evaluation of Outcomes), in patients with septic shock, as defined according to clinical criteria. Patients will be randomized in a 1:1:1:1 ratio to one of the 4 study groups (Albumin + BAL, Albumin + NS, BAL, NS). Both the primary endpoints will include events evaluated objectively: 90-day mortality and incidence of AKI, as assessed by KDIGO criteria (KDIGO Acute Kidney Injury Work Group, 2012).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock
Keywords
Septic Shock, Albumin, Balanced crystalloids

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Model Description
2-by-2 factorial design, open-label, multicenter, randomized, controlled trial, in patients with septic shock, as defined according to clinical criteria. Patients will be randomized in a 1:1:1:1 ratio to one of the 4 groups (Albumin + BAL, Albumin + NS, BAL, NS).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1252 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Albumin + Balanced
Arm Type
Experimental
Arm Description
Human Albumin In parallel with fluid administration for volume resuscitation, patients will receive 400 ml of 20% albumin solution both at randomization (D0) and at day 1 (D1). Subsequently, from day 2 (D2) until day 90 (D90) or ICU discharge (whichever comes first), 20% albumin will be administered on a daily basis, to maintain serum albumin concentration equal to or greater than 30 g/L, based upon serum albumin determination. Balanced crystalloid solutions According to the preference and the standard use of the participating center: Ringer Lactate Ringer Acetate Crystalsol
Arm Title
Albumin + Saline
Arm Type
Experimental
Arm Description
Human Albumin In parallel with fluid administration for volume resuscitation, patients will receive 400 ml of 20% albumin solution both at randomization (D0) and at day 1 (D1). Subsequently, from day 2 (D2) until day 90 (D90) or ICU discharge (whichever comes first), 20% albumin will be administered on a daily basis, to maintain serum albumin concentration equal to or greater than 30 g/L, based upon serum albumin determination. Normal Saline Na+ 154 mEq/L, Cl- 154 mEq/L (0.9% NaCl).
Arm Title
Balanced
Arm Type
Experimental
Arm Description
Balanced crystalloid solutions (Ringer Lactate, Ringer Acetate, Crystalsol)
Arm Title
Saline
Arm Type
No Intervention
Arm Description
Normal Saline Na+ 154 mEq/L, Cl- 154 mEq/L (0.9% NaCl).
Intervention Type
Biological
Intervention Name(s)
Albumin
Intervention Description
Human Albumin In parallel with fluid administration for volume resuscitation, patients will receive 400 ml of 20% albumin solution both at randomization (D0) and at day 1 (D1). Subsequently, from day 2 (D2) until day 90 (D90) or ICU discharge (whichever comes first), 20% albumin will be administered on a daily basis, to maintain serum albumin concentration equal to or greater than 30 g/L, based upon serum albumin determination.
Intervention Type
Other
Intervention Name(s)
Balanced
Other Intervention Name(s)
Ringer Lactate, Ringer Acetate, Crystalsol
Intervention Description
Balanced crystalloid solutions are traditionally crystalloid solutions containing a relatively low concentration of chloride as compared to 0.9% NaCl containing solutions (Normal Saline).
Primary Outcome Measure Information:
Title
All-cause 90-day mortality
Description
All-cause death from randomization to 90 days
Time Frame
Up to 90 days
Title
Combined co-primary endpoint
Description
The composite of all-cause death from randomization to 90 days and new occurrence of acute kidney injury (AKI).
Time Frame
Up to 90 days
Secondary Outcome Measure Information:
Title
ICU mortality
Description
All-cause death occurring in Intensive Care Unit (ICU)
Time Frame
Up to ICU discharge, a median of 9 days
Title
In-hospital mortality
Description
All-cause death occurring during hospital stay
Time Frame
Up to hospital discharge, a median of 20 days
Title
1-year mortality
Description
All-cause death from randomization to 1 year
Time Frame
Up to 1 year
Title
SOFA score
Description
Severity and incidence of organ failures, as assessed by the Sequential Organ Failure Assessment (SOFA) score. SOFA score is used to determine the extent of organ function in a patient while in the intensive care unit. The score is based on 6 different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems. The scale of each score ranges from 0 (no dysfunction) to 4 (maximal dysfunction). The 6 scores are then added up to provide a global score: the highest the value, the worst the condition of the patient.
Time Frame
Up to 90 days or ICU discharge - a median of 9 days - whichever comes first
Title
Incidence of AKI
Description
Assessed by the Kidney Disease Improving Global Outcome (KDIGO) criteria as any of the following: (1) increase in serum creatinine >=0.3 mg/dl (26.5 mmol/l) within 48 hours; or (2) increase in SCr to >=1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or (3) urine volume <0.5 ml/kg/h for 6 hours.
Time Frame
Up to 90 days or ICU discharge - a median of 9 days - whichever comes first
Title
RRT
Description
First use of Renal Replacement Therapy (RRT) during ICU stay
Time Frame
Up to 90 days or ICU discharge - a median of 9 days - whichever comes first
Title
Need for vasopressors
Description
Duration of the need for vasopressors during ICU stay
Time Frame
Up to 90 days or ICU discharge - a median of 9 days - whichever comes first
Title
Mechanical ventilation
Description
Duration of mechanical ventilation during ICU stay
Time Frame
Up to 90 days or ICU discharge - a median of 9 days - whichever comes first
Title
Secondary infections in ICU
Description
Incidence of secondary-acquired infections during ICU stay
Time Frame
Up to 90 days or ICU discharge - a median of 9 days - whichever comes first
Title
Duration of stay in ICU
Description
Duration expressed as number of days spent in ICU
Time Frame
Up to ICU discharge, a median of 9 days
Title
Duration of stay in hospital
Description
Duration expressed as number of days spent in hospital
Time Frame
Up to hospital discharge, a median of 20 days
Other Pre-specified Outcome Measures:
Title
Severe metabolic acidosis
Description
Incidence of severe metabolic acidosis
Time Frame
Up to 90 days or ICU discharge - a median of 9 days - whichever comes first
Title
Severe hyperkalemia
Description
Incidence of severe hyperkalemia
Time Frame
Up to 90 days or ICU discharge - a median of 9 days - whichever comes first

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with septic shock if they meet the two following criteria: Presence of an infection (known or suspected) in at least one site: Lung Abdomen Urinary tract Others (blood, skin and soft tissues, central nervous system, bones and joints, cardiac system, reproductive organs). Presence of a severe and acute, sepsis-related cardiovascular failure (as assessed by the SOFA score - see Annex 1), requiring vasopressor to maintain mean arterial pressure >=65 mmHg, despite adequate volume resuscitation a) Cardiovascular SOFA score > 2 (3 or 4) If the patient is unable to provide informed consent, she/he can be included in the trial provided that the requirements of ongoing laws are fulfilled; details on this approach are provided in the protocol, par 11.1 and related Annex 3. The patient will be informed about having been included in a clinical trial, as soon as she/he will regain consciousness. Exclusion Criteria: Age < 18 years Moribund state Known or suspected adverse reaction to albumin administration Septic shock in patients with traumatic brain injury or a clinically active cerebral lesion (known or suspected) Severe congestive heart failure (NYHA III and IV classes) Clinical situations in which the use of albumin is known or supposed to be clinically beneficial (hepatic cirrhosis with ascites, malabsorption syndrome or protein-losing enteropathy, nephrotic syndrome, burns) More than 24 hours after the onset of septic shock Religious objection to the administration of human blood products Presence of chronic end-stage renal disease Severe hyperkalemia Enrollment in other experimental interventional studies
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonio Pesenti, MD
Phone
+390255033231
Email
antonio.pesenti@unimi.it
First Name & Middle Initial & Last Name or Official Title & Degree
Pietro Caironi, MD
Phone
+393316171966
Email
pietro.caironi@unito.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pietro Caironi, MD
Organizational Affiliation
AOU S. Luigi Gonzaga, Orbassano
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedali Riuniti di Ancona
City
Ancona
State/Province
AN
ZIP/Postal Code
60126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abele Donati, MD
Phone
+39 071 596 4603
Email
abele.donati@ospedaliriuniti.marche.it
Facility Name
Ospedale Regionale Umberto Parini
City
Aosta
State/Province
AO
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
AOU Policlinico di Bari
City
Bari
State/Province
BA
ZIP/Postal Code
70124
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
ASST Papa Giovanni XXIII
City
Bergamo
State/Province
BG
ZIP/Postal Code
24127
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabrizio Fabretti, MD
Phone
0352675162
Email
ffabbretti@asst-hpg23.it
Facility Name
ASST BG Est - Ospedale Bolognini
City
Seriate
State/Province
BG
ZIP/Postal Code
24068
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberto Keim, MD
Phone
0353063270
Email
roberto.keim@asst-bergamoest.it
Facility Name
AST BG Ovest - PO Treviglio
City
Treviglio
State/Province
BG
ZIP/Postal Code
24047
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Massimo Borelli, MD
Phone
0363424230
Email
massimo_borelli@asst-bgovest.it
Facility Name
Policlinico Sant'Orsola-Malpighi
City
Bologna
State/Province
BO
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
AOU Mater Domini Catanzaro
City
Catanzaro
State/Province
CZ
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Azienda Ospedaliero - Universitaria di Ferrara - Arcispedale Sant'Anna
City
Cona
State/Province
FE
ZIP/Postal Code
44124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlo Alberto Volta, MD
Phone
0532236451
Email
vlc@unife.it
Facility Name
Ospedali Riuniti di Foggia
City
Foggia
State/Province
FG
ZIP/Postal Code
71121
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Ospedale del Mugello
City
Borgo San Lorenzo
State/Province
FI
ZIP/Postal Code
50032
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vieri Parrini, MD
Phone
05584451310
Email
vieri.parrini@uslcentro.tosca.it
Facility Name
Ospedale San Giuseppe
City
Empoli
State/Province
FI
ZIP/Postal Code
50053
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
AOU Careggi
City
Firenze
State/Province
FI
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefano Romagnoli, MD
Phone
055 0760007
Email
stefano.romagnoli@unifi.it
Facility Name
Ente Ospedaliero Ospedali Galliera
City
Genova
State/Province
GE
ZIP/Postal Code
16128
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco Lattuada, MD
Phone
01056231
Email
marco.lattuada@galliera.it
Facility Name
Ospedale Policlinico San Martino
City
Genova
State/Province
GE
ZIP/Postal Code
16132
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paolo Pelosi, MD
Phone
0105554982
Email
ppelosi@hotmail.com
Facility Name
Ospedale Colline dell'Albegna
City
Orbetello
State/Province
GR
ZIP/Postal Code
58045
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giovanni Pasetti, MD
Phone
05644869212
Email
giovannistefano.pasetti@uslsudest.toscana.it
Facility Name
ASST Lecco AO Manzoni
City
Lecco
State/Province
LC
ZIP/Postal Code
23900
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Ospedale Vito Fazzi
City
Lecce
State/Province
LE
ZIP/Postal Code
73100
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Presidio Ospedaliero di Desio
City
Desio
State/Province
MB
ZIP/Postal Code
20039
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Citerio, MD
Phone
0362383213
Email
giuseppe.citerio@unimib.it
Facility Name
Azienda Ospedaliera S. Gerardo
City
Monza
State/Province
MB
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giacomo Bellani, MD
Phone
039 233 9269
Email
giacomo.bellani1@unimib.it
Facility Name
ASST Nord Milano - Ospedale Bassini
City
Cinisello Balsamo
State/Province
MI
ZIP/Postal Code
20092
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angelo Pezzi, MD
Phone
0257998271
Email
angelo.pezzi@asst-nordmilano.it
Facility Name
ASST Ovest Milano
City
Legnano
State/Province
MI
ZIP/Postal Code
20025
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danilo Radrizzani, MD
Phone
0331449458
Email
danilo.radrizzani@asst-ovestmi.it
Facility Name
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
City
Milano
State/Province
MI
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Pesenti, MD
Phone
0255033230
Email
antonio.pesenti@unimi.it
Facility Name
ASST Santi Paolo e Carlo, Ospedale San Paolo
City
Milano
State/Province
MI
ZIP/Postal Code
20142
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
ASST Fatebenefratelli - Sacco P.O. Sacco
City
Milano
State/Province
MI
ZIP/Postal Code
20157
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
ASST Grande Ospedale Metropolitano Niguarda
City
Milano
State/Province
MI
ZIP/Postal Code
20162
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Riccardo Pinciroli, MD
Phone
02644447235
Email
riccardo.pinciroli@unimib.it
Facility Name
IRCCS Policlinico San Donato
City
San Donato Milanese
State/Province
MI
ZIP/Postal Code
20097
Country
Italy
Individual Site Status
Suspended
Facility Name
Azienda Ospedaliero-Universitaria di Modena, Policlinico di Modena
City
Modena
State/Province
MO
ZIP/Postal Code
41125
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Massimo Girardis, MD
Phone
0594224813
Email
girardis.massimo@unimo.it
Facility Name
AOU Policlinico Paolo Giaccone
City
Palermo
State/Province
PA
ZIP/Postal Code
90127
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Cortegiani, MD
Phone
0916552738
Email
cortegiani@gmail.com
Facility Name
ISMETT
City
Palermo
State/Province
PA
ZIP/Postal Code
90127
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Arcadipane, MD
Phone
0912192378
Email
aarcadipane@ismett.edu
Facility Name
AOU Pisana
City
Pisa
State/Province
PI
ZIP/Postal Code
56126
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
As FO Azienda sanitaria Friuli Occidentale
City
Pordenone
State/Province
PN
ZIP/Postal Code
33170
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadia Todesco, MD
Phone
0434399522
Email
nadia.todesco@asfo.sanita.fvg.it
Facility Name
Azienda Ospedaliero - Universitaria di Parma
City
Parma
State/Province
PR
ZIP/Postal Code
43123
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Fondazione IRCCS Policlinico San Matteo
City
Pavia
State/Province
PV
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giorgio Iotti, MD
Phone
0382503477
Email
g.iotti@smatteo.pv.it
Facility Name
IRCCS ASMN Reggio Emilia
City
Reggio Emilia
State/Province
RE
ZIP/Postal Code
43123
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giovanni Salati, MD
Phone
0522236599
Email
giovanni.salati@ausl.re.it
Facility Name
Fondazione Policlinico Universitario A. Gemelli, Università Cattolica del Sacro Cuore
City
Roma
State/Province
RM
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Massimo Antonelli, MD
Phone
0630154490
Email
m.antonelli@rm.unicatt.it
Facility Name
Azienda Ospedaliera Universitaria Sassari
City
Sassari
State/Province
SS
ZIP/Postal Code
07100
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierpaolo Terragni, MD
Phone
079228270
Email
pterragni@uniss.it
Facility Name
Ospedale Santa Chiara
City
Trento
State/Province
TN
ZIP/Postal Code
38122
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Ospedale Santa Croce
City
Moncalieri
State/Province
TO
ZIP/Postal Code
10024
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Azienda Ospedaliero - Universitaria S. Luigi Gonzaga
City
Orbassano
State/Province
TO
ZIP/Postal Code
10043
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pietro Caironi, MD
Phone
0119026386
Email
pietro.caironi@unito.it
Facility Name
AOU Città della Salute e della Scienza di Torino
City
Torino
State/Province
TO
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luca Brazzi, MD
Phone
0116335500
Email
luca.brazzi@unito.it
Facility Name
ASU Giuliano Isontina
City
Trieste
State/Province
TS
ZIP/Postal Code
34128
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Azienda Sanitaria Universitaria Integrata di Udine
City
Udine
State/Province
UD
ZIP/Postal Code
33100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tiziana Bove, MD
Phone
0432 559501
Email
clinicaanestesiarianimazione@asuiud.sanita.fvg.it
Facility Name
Ospedale Galmarini Tradate
City
Tradate
State/Province
VA
ZIP/Postal Code
21049
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Ospedale di Circolo e Fondazione Macchi
City
Varese
State/Province
VA
ZIP/Postal Code
21100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luca Cabrini, MD
Phone
0332 278111
Email
l.cabrini@asst-settelaghi.it
Facility Name
Azienda Ospedaliera Universitaria Integrata di Verona
City
Verona
State/Province
VR
ZIP/Postal Code
37126
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Ospedale SS. Antonio e Biagio e Cesare Arrigo
City
Alessandria
ZIP/Postal Code
15121
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valeria Bonato, MD
Phone
0131266347
Email
vbonato@ospedale.al.it
Facility Name
Ospedale San Carlo Borromeo
City
Milano
ZIP/Postal Code
20153
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefano Muttini, MD
Phone
0240222958
Email
stefano.muttini@asst-santipaolocarlo.it
Facility Name
Azienda Ospedaliero-Universitaria Sant'Andrea
City
Roma
ZIP/Postal Code
1035
Country
Italy
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24635772
Citation
Caironi P, Tognoni G, Masson S, Fumagalli R, Pesenti A, Romero M, Fanizza C, Caspani L, Faenza S, Grasselli G, Iapichino G, Antonelli M, Parrini V, Fiore G, Latini R, Gattinoni L; ALBIOS Study Investigators. Albumin replacement in patients with severe sepsis or septic shock. N Engl J Med. 2014 Apr 10;370(15):1412-21. doi: 10.1056/NEJMoa1305727. Epub 2014 Mar 18.
Results Reference
result
PubMed Identifier
20924555
Citation
SAFE Study Investigators; Finfer S, McEvoy S, Bellomo R, McArthur C, Myburgh J, Norton R. Impact of albumin compared to saline on organ function and mortality of patients with severe sepsis. Intensive Care Med. 2011 Jan;37(1):86-96. doi: 10.1007/s00134-010-2039-6. Epub 2010 Oct 6.
Results Reference
result
PubMed Identifier
25099709
Citation
Patel A, Laffan MA, Waheed U, Brett SJ. Randomised trials of human albumin for adults with sepsis: systematic review and meta-analysis with trial sequential analysis of all-cause mortality. BMJ. 2014 Jul 22;349:g4561. doi: 10.1136/bmj.g4561. Erratum In: BMJ. 2014;349:g4850.
Results Reference
result
PubMed Identifier
29768150
Citation
Semler MW, Self WH, Rice TW. Balanced Crystalloids versus Saline in Critically Ill Adults. N Engl J Med. 2018 May 17;378(20):1951. doi: 10.1056/NEJMc1804294.
Results Reference
result
PubMed Identifier
23984731
Citation
Angus DC, van der Poll T. Severe sepsis and septic shock. N Engl J Med. 2013 Aug 29;369(9):840-51. doi: 10.1056/NEJMra1208623. No abstract available. Erratum In: N Engl J Med. 2013 Nov 21;369(21):2069.
Results Reference
result

Learn more about this trial

ALBumin Italian Outcome Septic Shock-BALANCED Trial (ALBIOSS-BALANCED)

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