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Albumin Replacement Therapy in Septic Shock (ARISS)

Primary Purpose

Septic Shock

Status
Unknown status
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Albutein® 200 g/L or Plasbumin® 20
Sponsored by
Jena University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock focused on measuring Human albumin, Sepsis

Eligibility Criteria

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

Inclusion Criteria:

  • The presence of septic shock meeting all of the following criteria:

    • Clinically possible or probable or microbiologically confirmed infection taking into account the definitions of the "International Sepsis Forum (ISF)"
    • Despite adequate volume therapy, vasopressors are required to maintain mean arterial pressure (MAP) ≥ 65 mm Hg for at least 1 hour
    • Serum lactate level > 2 mmol/l (18 mg/dl) despite adequate volume therapy
  • Start of septic shock less than 24 hours prior to inclusion, so that the start dose of the trial drug in the albumin group will be possible within 6-24 hours after the start of the septic shock
  • Age: ≥ 18 years
  • Written informed consent of the patient or his/her legal representative or confirmation of the urgency of participation in the clinical trial and possible benefit to the patient by an independent consultant or the implementation of other established procedures according to the local regulations of the contributing centre to include patients who are unable to provide informed consent in whom subsequent consent may be obtained retrospectively.
  • Patients of childbearing age: negative pregnancy test

Exclusion Criteria:

  • Moribund conditions with life expectancy less than 28 days because of comorbid conditions or advanced malignant disease and palliative situations with life expectancy less than 6 months
  • Presence of an "end of life" decision prior to obtaining informed consent: "Do Not Resuscitate (DNR)" and "Withhold/Withdraw Life-Sustaining measures"
  • Previous participation in this study
  • Participation in another interventional clinical trial within the past 3 months
  • Shock states that can be explained by other causes, e.g. cardiogenic shock, anaphylactic shock, neurogenic shock
  • History of hypersensitivity to albumin or any other component of the trial drug, e.g., B., sodium caprylate, sodium N-acetyltryptophanate
  • Diseases in which albumin administration may be deleterious, e.g., decompensated heart failure or traumatic brain injury
  • Clinical conditions where albumin administration is indicated, e.g., hepatorenal syndrome, nephrosis, burns, intestinal malabsorption syndrome
  • Lactation

Sites / Locations

  • Klinikum Augsburg, Klinik für Anästhesiologie und Operative IntensivmedizinRecruiting
  • Helios Klinikum Bad Saarow, Klinik für IntensivmedizinRecruiting
  • Vivantes Humboldt Klinikum, Klinik für Innere Medizin, Kardiologie und konservative Intensivmedizin
  • Universitätsklinikum Bonn, Klinik für Anästesiologie und Operative IntensivmedizinRecruiting
  • Universitätsklinikum Erlangen, Anästesiologische KlinikRecruiting
  • Universitätsklinikum Freiburg, Klinik für Allgemein- und Viszeralchirurgie, Chir. IntensivstationRecruiting
  • Universitätsmedizin Greifswald, Klinik für Anästhesiologie, Intensiv-, Notfall- und SchmerzmedizinRecruiting
  • Universitätsmedizin Göttingen, Klinik für Anästhesiologie, Rettungs- und IntensivmedizinRecruiting
  • Universitätsklinikum Hamburg-Eppendorf, Klinik für IntensivmedizinRecruiting
  • Universitätsklinikum Heidelberg, Klinik für AnästhesiologieRecruiting
  • Klinikum Herford, Medizinische Klinik III, KardiologieRecruiting
  • Marien Hospital Herne, Universitätsklinikum der Ruhr-Universität Bochum, Klinik für Anästhesiologie, Operative Intensivmedizin, Schmerztherapie, PalliativmedizinRecruiting
  • Universitätsklinikum des Saarlandes, Klinik für Anästhesiologie, Intensivmedizin und SchmerztherapieRecruiting
  • Universitätsklinikum Jena, Innere Medizin I, KardiologieRecruiting
  • Universitätsklinikum Jena, Klinik für Innere Medizin I, KardiologieRecruiting
  • Universitätsklinikum Schleswig-Holstein, Klinik für Operative IntensivmedizinRecruiting
  • St. Elisabeth Krankenhaus, Klinik für Anästhesiologie, Operative Intensivmedizin und SchmerztherapieRecruiting
  • Universitätsklinikum Leipzig, Interdisziplinäre Internistische IntensivmedizinRecruiting
  • Universitätsklinikum Leipzig, Klinik für Anästhesiologie u. IntensivtherapieRecruiting
  • Universitätsklinikum Leipzig, Klinik und Poliklinik für NeurologieRecruiting
  • Universitätsklinikum Magdeburg, Klinik für Innere Medizin, Kardiologie und AngiologieRecruiting
  • Universitätsklinikum Magdeburg, Klinik für Anästhesiologie und IntensivmedizinRecruiting
  • Universitätsklinikum der Johannes-Gutenberg-Universität Mainz, Klinik für AnästhesiologieRecruiting
  • Klinikum der LMU München, Klinik für AnästhesiologieRecruiting
  • Klinikum rechts der Isar der TU München, Klinik für Anästhesiologie und IntensivmedizinRecruiting
  • Universitätsklinikum Münster, Klinik für Anästesiologie, operative Intensivmedizin und SchmerztherapieRecruiting
  • Universitätsklinikum Regensburg, Klinik und Poliklinik für ChirurgieRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Albumin group

Control group without albumin:

Arm Description

Patients assigned to the Albumin group will receive a 60 g loading dose of human albumin 20% over 2-3 hours. Serum albumin levels will be maintained at least at 30 g/l in the ICU for a maximum of 28 days following randomization using 40-80 g human albumin 20% infusion.

The control group will be treated according to the usual practice with crystalloids as the first choice for the resuscitation and maintenance phase of septic shock.

Outcomes

Primary Outcome Measures

90-day all cause mortality
Mortality within 90 days after randomisation

Secondary Outcome Measures

28-day mortality
Mortality within 28 days after randomisation
60-day mortality
Mortality within 60 days after randomisation
Organ failure
Organ failure defined as increase in the daily recorded Sequential organ Failure Assessement (SOFA) subscores; cardiovascular, respiratory, hematologic, hepatic, renal, neurologic (range 0-4 points each) from a value <2 to a value ≥ 2
Sequential Organ Failure Assessement (SOFA) score
The overall degree of organ dysfunction/failure assessed daily by the total SOFA score (range 0-24 points), with higher scores indicating higher degree of overall organ dysfunction/failure).
ICU length of stay
ICU stay of first hospitalization after randomisation within 90 days
Hospital length of stay
Hospital stay of first hospitalization after randomisation within 90 days
Ventilation-free days
Ventilation-free days within 28 days after randomisation
Vasopressor-free days
Vasopressor-free days within 28 days after randomisation
Total amount of fluid of fluid administration and total fluid balance in the ICU.
Total amount of fluid of fluid administration and total fluid balance in the ICU within 28 days after randomisation

Full Information

First Posted
March 8, 2019
Last Updated
June 24, 2021
Sponsor
Jena University Hospital
Collaborators
German Research Foundation, Instituto Grifols, S.A., University Hospital Goettingen, SepNet - Critical Care Trials Group, Center for Sepsis Control and Care, Germany, The Center for Clinical Trials (ZKS), Jena
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1. Study Identification

Unique Protocol Identification Number
NCT03869385
Brief Title
Albumin Replacement Therapy in Septic Shock
Acronym
ARISS
Official Title
Randomised Controlled Multicentre Study of Albumin Replacement Therapy in Septic Shock
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 21, 2019 (Actual)
Primary Completion Date
October 30, 2022 (Anticipated)
Study Completion Date
January 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jena University Hospital
Collaborators
German Research Foundation, Instituto Grifols, S.A., University Hospital Goettingen, SepNet - Critical Care Trials Group, Center for Sepsis Control and Care, Germany, The Center for Clinical Trials (ZKS), Jena

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Albumin is a key regulator of fluid distribution within the extracellular space and possesses several properties beyond its oncotic activity, including binding and transport of several endogenous molecules, anti-inflammatory and anti-oxidant actions, nitric oxide modulation, and buffer function. The accumulating evidence suggests that supplementation of albumin may provide survival advantages only when the insult is severe as in patients with septic shock. Prospective randomized trials on the possible impact of albumin replacement in these patients with septic shock are lacking. The aim of the study is to investigate whether the replacement with albumin and the maintenance of its serum levels at least at 30 g/l for 28 days improve survival in patients with septic shock compared to resuscitation and volume maintenance without albumin. In this prospective, multicenter, randomised trial, adult patients (≥18 years) with septic shock will be randomly assigned within a maximum of 24 hours after the onset of septic shock after obtaining informed consents to treatment or control groups. Patients assigned to the treatment group will receive a 60 g loading dose of human albumin 20% over 2-3 hours. Serum albumin levels will be maintained at least at 30 g/l in the ICU for a maximum of 28 days following randomization using 40-80 g human albumin 20% infusion. The control group will be treated according to the usual practice with crystalloids as the first choice for the resuscitation and maintenance phase of septic shock. The primary end point is 90 days mortality and secondary end points include 28-day, 60-day, ICU, and in-hospital mortality, organ dysfunction/failure, and length of ICU and hospital stay. In total 1412 patients need to be analyzed, 706 per group. Assuming a dropout rate of 15%, a total of 1662 patients need to be allocated.
Detailed Description
This is a prospective, multicentre, randomised, controlled, parallel-grouped, open-label, interventional clinical trial in which 1662 patients are planned to be allocated. Subjects will be randomized in a 1:1 ratio to receive either Albumin or routine treatment with crystalloids. Treatment will be continued at maximum for 28 days or until the patient leaves the ICU. Primary endpoint measurement will be carried out 90 days after randomisation

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock
Keywords
Human albumin, Sepsis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1662 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Albumin group
Arm Type
Experimental
Arm Description
Patients assigned to the Albumin group will receive a 60 g loading dose of human albumin 20% over 2-3 hours. Serum albumin levels will be maintained at least at 30 g/l in the ICU for a maximum of 28 days following randomization using 40-80 g human albumin 20% infusion.
Arm Title
Control group without albumin:
Arm Type
No Intervention
Arm Description
The control group will be treated according to the usual practice with crystalloids as the first choice for the resuscitation and maintenance phase of septic shock.
Intervention Type
Drug
Intervention Name(s)
Albutein® 200 g/L or Plasbumin® 20
Other Intervention Name(s)
Human Albumin 20%
Intervention Description
The initial dose of the trial drug must be started within 6 to 24 hours after the beginning of the septic shock. Starting dose: 60 g human albumin 20% (Albutein® 200 g/L, infusion solution) over 2-3 h Daily administration of the trial drug will be based on the serum albumin concentration measured each day. Dose adjustment will follow a predetermined schedule with the aim of maintaining a serum albumin concentration of at least 30 g/l. Administration of the trial drug will continue for a maximum of 28 study days after randomisation and only as long as the participant is being treated in the ICU.
Primary Outcome Measure Information:
Title
90-day all cause mortality
Description
Mortality within 90 days after randomisation
Time Frame
90 days
Secondary Outcome Measure Information:
Title
28-day mortality
Description
Mortality within 28 days after randomisation
Time Frame
28 days
Title
60-day mortality
Description
Mortality within 60 days after randomisation
Time Frame
60 days
Title
Organ failure
Description
Organ failure defined as increase in the daily recorded Sequential organ Failure Assessement (SOFA) subscores; cardiovascular, respiratory, hematologic, hepatic, renal, neurologic (range 0-4 points each) from a value <2 to a value ≥ 2
Time Frame
28 days
Title
Sequential Organ Failure Assessement (SOFA) score
Description
The overall degree of organ dysfunction/failure assessed daily by the total SOFA score (range 0-24 points), with higher scores indicating higher degree of overall organ dysfunction/failure).
Time Frame
28 days
Title
ICU length of stay
Description
ICU stay of first hospitalization after randomisation within 90 days
Time Frame
90 days
Title
Hospital length of stay
Description
Hospital stay of first hospitalization after randomisation within 90 days
Time Frame
90 days
Title
Ventilation-free days
Description
Ventilation-free days within 28 days after randomisation
Time Frame
28 days
Title
Vasopressor-free days
Description
Vasopressor-free days within 28 days after randomisation
Time Frame
28 days
Title
Total amount of fluid of fluid administration and total fluid balance in the ICU.
Description
Total amount of fluid of fluid administration and total fluid balance in the ICU within 28 days after randomisation
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The presence of septic shock meeting all of the following criteria: Clinically possible or probable or microbiologically confirmed infection taking into account the definitions of the "International Sepsis Forum (ISF)" Despite adequate volume therapy, vasopressors are required to maintain mean arterial pressure (MAP) ≥ 65 mm Hg for at least 1 hour Serum lactate level > 2 mmol/l (18 mg/dl) despite adequate volume therapy Start of septic shock less than 24 hours prior to inclusion, so that the start dose of the trial drug in the albumin group will be possible within 6-24 hours after the start of the septic shock Age: ≥ 18 years Written informed consent of the patient or his/her legal representative or confirmation of the urgency of participation in the clinical trial and possible benefit to the patient by an independent consultant or the implementation of other established procedures according to the local regulations of the contributing centre to include patients who are unable to provide informed consent in whom subsequent consent may be obtained retrospectively. Patients of childbearing age: negative pregnancy test Exclusion Criteria: Moribund conditions with life expectancy less than 28 days because of comorbid conditions or advanced malignant disease and palliative situations with life expectancy less than 6 months Presence of an "end of life" decision prior to obtaining informed consent: "Do Not Resuscitate (DNR)" and "Withhold/Withdraw Life-Sustaining measures" Previous participation in this study Participation in another interventional clinical trial within the past 3 months Shock states that can be explained by other causes, e.g. cardiogenic shock, anaphylactic shock, neurogenic shock History of hypersensitivity to albumin or any other component of the trial drug, e.g., B., sodium caprylate, sodium N-acetyltryptophanate Diseases in which albumin administration may be deleterious, e.g., decompensated heart failure or traumatic brain injury Clinical conditions where albumin administration is indicated, e.g., hepatorenal syndrome, nephrosis, burns, intestinal malabsorption syndrome Lactation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yasser Sakr, MD, PhD
Phone
01742191538
Ext
0049
Email
yasser.sakr@med.uni-jena.de
Facility Information:
Facility Name
Klinikum Augsburg, Klinik für Anästhesiologie und Operative Intensivmedizin
City
Augsburg
ZIP/Postal Code
86156
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ulrich Jaschinski, Dr.
First Name & Middle Initial & Last Name & Degree
Philipp Deetjen, Dr.
Facility Name
Helios Klinikum Bad Saarow, Klinik für Intensivmedizin
City
Bad Saarow
ZIP/Postal Code
15526
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lukas Kreienbühl, Dr.
First Name & Middle Initial & Last Name & Degree
Stefan P. Wirtz, Dr.
Facility Name
Vivantes Humboldt Klinikum, Klinik für Innere Medizin, Kardiologie und konservative Intensivmedizin
City
Berlin
ZIP/Postal Code
13509
Country
Germany
Individual Site Status
Completed
Facility Name
Universitätsklinikum Bonn, Klinik für Anästesiologie und Operative Intensivmedizin
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Putensen, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Carsten Weißbrich, Dr.
Facility Name
Universitätsklinikum Erlangen, Anästesiologische Klinik
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreas Wehrfritz, Dr.
First Name & Middle Initial & Last Name & Degree
Ixchel Castellonos, Dr.
Facility Name
Universitätsklinikum Freiburg, Klinik für Allgemein- und Viszeralchirurgie, Chir. Intensivstation
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Utzolino, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Lampros Kousoulas, Dr.
Facility Name
Universitätsmedizin Greifswald, Klinik für Anästhesiologie, Intensiv-, Notfall- und Schmerzmedizin
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Scheer, Dr.
First Name & Middle Initial & Last Name & Degree
Sven-Olaf Kuhn, Dr.
Facility Name
Universitätsmedizin Göttingen, Klinik für Anästhesiologie, Rettungs- und Intensivmedizin
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Onnen Mörer, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Michael Quintel, Prof. Dr.
Facility Name
Universitätsklinikum Hamburg-Eppendorf, Klinik für Intensivmedizin
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephan Kluge, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Axel Nierhaus, Dr.
Facility Name
Universitätsklinikum Heidelberg, Klinik für Anästhesiologie
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johann Motsch, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Jan Larmann, Dr.
Facility Name
Klinikum Herford, Medizinische Klinik III, Kardiologie
City
Herford
ZIP/Postal Code
32049
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Kähler, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Marc Werner, Dr.
Facility Name
Marien Hospital Herne, Universitätsklinikum der Ruhr-Universität Bochum, Klinik für Anästhesiologie, Operative Intensivmedizin, Schmerztherapie, Palliativmedizin
City
Herne
ZIP/Postal Code
44625
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florian Roghmann, PD Dr.
First Name & Middle Initial & Last Name & Degree
Metin Senkal, Prof. Dr.
Facility Name
Universitätsklinikum des Saarlandes, Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie
City
Homburg
ZIP/Postal Code
66421
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreas Meiser, Dr.
First Name & Middle Initial & Last Name & Degree
Tanja Meisel, Dr.
Facility Name
Universitätsklinikum Jena, Innere Medizin I, Kardiologie
City
Jena
ZIP/Postal Code
07747
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chrsitian Schulze, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Julian Westphal, Dr.
Facility Name
Universitätsklinikum Jena, Klinik für Innere Medizin I, Kardiologie
City
Jena
ZIP/Postal Code
07747
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasser Sakr, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Julian Westphal, Dr.
Facility Name
Universitätsklinikum Schleswig-Holstein, Klinik für Operative Intensivmedizin
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Norbert Weiler, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Ingmar Lautenschläger, Dr.
Facility Name
St. Elisabeth Krankenhaus, Klinik für Anästhesiologie, Operative Intensivmedizin und Schmerztherapie
City
Köln
ZIP/Postal Code
50935
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fritz Fiedler, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Petra Tepaß, Dr.
Facility Name
Universitätsklinikum Leipzig, Interdisziplinäre Internistische Intensivmedizin
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sirak Petros, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Lorenz Weidhase, Dr.
Facility Name
Universitätsklinikum Leipzig, Klinik für Anästhesiologie u. Intensivtherapie
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Falk Fichtner, Dr.
First Name & Middle Initial & Last Name & Degree
Michael Röder
Facility Name
Universitätsklinikum Leipzig, Klinik und Poliklinik für Neurologie
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katja Wartenberg, Dr.
First Name & Middle Initial & Last Name & Degree
Dominic Michalski, PD Dr.
Facility Name
Universitätsklinikum Magdeburg, Klinik für Innere Medizin, Kardiologie und Angiologie
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivan Tanev, Dr.
First Name & Middle Initial & Last Name & Degree
Alexander Schmeisser, Prof. Dr.
Facility Name
Universitätsklinikum Magdeburg, Klinik für Anästhesiologie und Intensivmedizin
City
Magdeburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Jacob, Dr.
First Name & Middle Initial & Last Name & Degree
Uwe Lodes
Facility Name
Universitätsklinikum der Johannes-Gutenberg-Universität Mainz, Klinik für Anästhesiologie
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marion Ferner, Dr.
First Name & Middle Initial & Last Name & Degree
Patrick Schramm, Dr.
Facility Name
Klinikum der LMU München, Klinik für Anästhesiologie
City
München
ZIP/Postal Code
81377
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandra Frank, PD Dr.
First Name & Middle Initial & Last Name & Degree
Stefan Stern-Straeter, Dr.
Facility Name
Klinikum rechts der Isar der TU München, Klinik für Anästhesiologie und Intensivmedizin
City
München
ZIP/Postal Code
81675
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Kapfer, Dr.
First Name & Middle Initial & Last Name & Degree
Jan Martin, Dr.
Facility Name
Universitätsklinikum Münster, Klinik für Anästesiologie, operative Intensivmedizin und Schmerztherapie
City
Münster
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Zarbrock, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Melanie Meersch, Dr.
Facility Name
Universitätsklinikum Regensburg, Klinik und Poliklinik für Chirurgie
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hans Jürgen Schlitt, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Thomas Dienemann, Dr.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33287911
Citation
Sakr Y, Bauer M, Nierhaus A, Kluge S, Schumacher U, Putensen C, Fichtner F, Petros S, Scheer C, Jaschinski U, Tanev I, Jacob D, Weiler N, Schulze PC, Fiedler F, Kapfer B, Brunkhorst F, Lautenschlaeger I, Wartenberg K, Utzolino S, Briegel J, Moerer O, Bischoff P, Zarbock A, Quintel M, Gattinoni L; SepNet - Critical Care Trials Group. Randomized controlled multicentre study of albumin replacement therapy in septic shock (ARISS): protocol for a randomized controlled trial. Trials. 2020 Dec 7;21(1):1002. doi: 10.1186/s13063-020-04921-y.
Results Reference
derived

Learn more about this trial

Albumin Replacement Therapy in Septic Shock

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