Back to results

Monitoring Resuscitation in Severe Sepsis and Septic Shock

Primary Purpose

Hemodynamics

Status

Unknown status

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Dynamic-parameters-guided fluid management

Standard-guided-fluid management

About this trial

This is an interventional treatment trial for Hemodynamics

Eligibility Criteria

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

Inclusion Criteria:

Age > 18 years
Clinical evidence of sepsis (microbiology confirmation, radiological or direct view - pus in biological fluid or surgical direct view-).
≥ 2 SIRS criteria:
- Temperature < 36.0°C or > 38.0°C
- Heart rate > 90 bpm
- Respiratory rate > 20 rpm or PaCO2 < 32 mmHg or need of mechanical ventilation.
- Leukocytes > 12.0 x109/L or < 4.0 x109/L
Hemodynamic insufficiency defined as (at least one of the following):
- Sustained systemic hypotension (systolic arterial pressure ≤ 90 mmHg or MAP < 65 mmHg) or a decrease in MAP of > 30 mm Hg in a hypertensive patient.
- Need of vasopressors.
- Tachycardia (HR > 110 bpm) or bradycardia (HR < 55 bpm)
- Acute onset of oliguria, defined as a decreased urine output < 0.5 ml/kg/hr for ≥ 2 hours
- Serum lactate > 2 mmol/l
- Peripheral cyanosis, mottled skin, prolonged capillary refill
Mechanical ventilation without any kind of inspiratory effort and Vt 7-10 mL/Kg, Pplateau < 30 mmH2O. Those patients with ARDS under mechanical ventilation will need to tolerate a tidal volume of at least 7 mL/Kg during 30 seconds while the plateau pressure remains < 30 mmH2O.
Prior hemodynamic monitoring by arterial catheter.
Central venous catheter.

Exclusion Criteria:

Acute myocardial infarction < 7 days.
Pregnancy
Prior request of limited code status or expected life length lower than 3 months.
Shock > 12h
Cardiac arrhythmia
Aortic valvular disease
Inability to properly measure arterial pressure wave forms

Sites / Locations

Area de Critics. Hospital de SabadellRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dynamic guide resuscitation

Standard resuscitation

Arm Description

This arm follows a resuscitation protocol based on dynamic-parameters-guided fluid management.

This arm follows a common resuscitation protocol based on Surviving Sepsis Campaign recommendations.

Outcomes

Primary Outcome Measures

Mortality at 28 days

Secondary Outcome Measures

Length of resuscitation

Vasopressor use and fluid load between 0h to 6h Vasopressor use and fluid load between 7h to 72h

Ventilator-free days

From 1 to 28 days over 28 days in a month.

Vasopressor-free days

From 1 to 28 days over 28 days in a month.

Organ failure-free days

Cardiovascular, CNS, renal, hepatic, coagulation abnormalities. From 1 to 28 days over 28 days in a month.

ICU length of stay

Hospital length of stay

Renal function evolution

Creatinin clearance will be calculated every day for the first 3 days (Cockroft-Gault formula).

Mortality at 3 months

Full Information

NCT ID

NCT01747057

First Posted

November 29, 2012

Last Updated

February 12, 2014

Sponsor

Corporacion Parc Tauli

1. Study Identification

Unique Protocol Identification Number

NCT01747057

Brief Title

Monitoring Resuscitation in Severe Sepsis and Septic Shock

Official Title

Monitoring Resuscitation in Severe Sepsis and Septic Shock

Study Type

Interventional

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Unknown status

Study Start Date

March 2013 (undefined)

Primary Completion Date

February 2015 (Anticipated)

Study Completion Date

May 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Corporacion Parc Tauli

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Our hypothesis is that hemodynamic fluid resuscitation guided by dynamic parameters will improve outcome in patients with severe sepsis and septic shock, by limiting the deleterious effects of fluid overload.

Detailed Description

To evaluate the efficacy of dynamic parameters versus static measures to guide fluid resuscitation we pretend to detect a 10% relative reduction in mortality. In addition, we pretend to observe an improvement on the length of resuscitation time, mechanical ventilation and vasopressor support-free days, ICU and hospital length of stay, organ failure and renal function.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemodynamics

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

952 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dynamic guide resuscitation

Arm Type

Experimental

Arm Description

This arm follows a resuscitation protocol based on dynamic-parameters-guided fluid management.

Arm Title

Standard resuscitation

Arm Type

Active Comparator

Arm Description

This arm follows a common resuscitation protocol based on Surviving Sepsis Campaign recommendations.

Intervention Type

Behavioral

Intervention Name(s)

Dynamic-parameters-guided fluid management

Intervention Description

● In preload-responsive patients defined by the following dynamic parameters: Patients fully adapted to mechanical ventilation* and with sinus rhythm. PPV >12%. PPV: Pulse pressure variation PPV = (PPmax-PPmin)/ [(PPmax+PPmin)/2] x100 (during 5 respiratory cycles) SVV > 12% (15). SVV: Stroke volume variation A tidal volume (Vt) ≥ 7-10cc/kg in mechanically ventilated (in a controlled mode - control volume or control pressure) and well-adapted patients without any inspiratory effort should be guaranteed. Fluid loading must be performed with crystalloids (1omL/Kg) or colloids (5ml/Kg) every 30 minutes until PPV-SVV < 12%, while hypoperfusion signs are present. Continue resuscitation following Surviving Sepsis Campaign rules excluding more fluid administration (as described in the standard intervention once CVP>12). ● Non-preload responsive patients (defined as PPV or SVV < 12%) will resume the same protocol as responders when fluid response parameters are negative.

Intervention Type

Behavioral

Intervention Name(s)

Standard-guided-fluid management

Intervention Description

Fluid loading in patients with hypotension or elevated lactates until normalization of MAP (> 65mmHg) or CVP > 12mmHg. If CVP reaches > 12 mmHg and MAP remains < 65mmHg, norepinephrine should be started to reach MAP > 65mmHg. Once MAP is restored, if hypoperfusion signs persist (elevated lactate or urine output < 0.5mL/Kg/h), ScvO2/SvO2 must be measured. In order to reach a ScvO2 ≥70% or SVO2 ≥65%, consider giving blood transfusion if hemoglobin level (Hb) ≤ 7g/dL, and also consider dobutamine (initial dose 2,5 µg/kg/min, increased by 2,5 µg/kg/min every 30 min up to a maximum dose of 20 µg/kg/min, presence of arrhythmia, or FC>110bpm). At that point, if hypoperfusion signs remain present, consider restart protocol from the beginning.

Primary Outcome Measure Information:

Title

Mortality at 28 days

Time Frame

28 days after hospital admission

Secondary Outcome Measure Information:

Title

Length of resuscitation

Description

Vasopressor use and fluid load between 0h to 6h Vasopressor use and fluid load between 7h to 72h

Time Frame

72 hours after protocol inclusion

Title

Ventilator-free days

Description

From 1 to 28 days over 28 days in a month.

Time Frame

28 days after admission

Title

Vasopressor-free days

Description

From 1 to 28 days over 28 days in a month.

Time Frame

28 days after admission

Title

Organ failure-free days

Description

Cardiovascular, CNS, renal, hepatic, coagulation abnormalities. From 1 to 28 days over 28 days in a month.

Time Frame

28 days after admission

Title

ICU length of stay

Time Frame

At ICU discharge (expected average 30 days after admission)

Title

Hospital length of stay

Time Frame

At hospital discharge (expected average 45 days after hospital admission)

Title

Renal function evolution

Description

Creatinin clearance will be calculated every day for the first 3 days (Cockroft-Gault formula).

Time Frame

3 days after study enrollment

Title

Mortality at 3 months

Time Frame

3 months after admission

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age > 18 years Clinical evidence of sepsis (microbiology confirmation, radiological or direct view - pus in biological fluid or surgical direct view-). ≥ 2 SIRS criteria: Temperature < 36.0°C or > 38.0°C Heart rate > 90 bpm Respiratory rate > 20 rpm or PaCO2 < 32 mmHg or need of mechanical ventilation. Leukocytes > 12.0 x109/L or < 4.0 x109/L Hemodynamic insufficiency defined as (at least one of the following): Sustained systemic hypotension (systolic arterial pressure ≤ 90 mmHg or MAP < 65 mmHg) or a decrease in MAP of > 30 mm Hg in a hypertensive patient. Need of vasopressors. Tachycardia (HR > 110 bpm) or bradycardia (HR < 55 bpm) Acute onset of oliguria, defined as a decreased urine output < 0.5 ml/kg/hr for ≥ 2 hours Serum lactate > 2 mmol/l Peripheral cyanosis, mottled skin, prolonged capillary refill Mechanical ventilation without any kind of inspiratory effort and Vt 7-10 mL/Kg, Pplateau < 30 mmH2O. Those patients with ARDS under mechanical ventilation will need to tolerate a tidal volume of at least 7 mL/Kg during 30 seconds while the plateau pressure remains < 30 mmH2O. Prior hemodynamic monitoring by arterial catheter. Central venous catheter. Exclusion Criteria: Acute myocardial infarction < 7 days. Pregnancy Prior request of limited code status or expected life length lower than 3 months. Shock > 12h Cardiac arrhythmia Aortic valvular disease Inability to properly measure arterial pressure wave forms

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xaime Garcia, MD

Phone

+34937231010

Ext

21156

xgarcia@tauli.cat

First Name & Middle Initial & Last Name or Official Title & Degree

Gisela Gili, RN

Phone

+34937231010

Ext

21159

ggilis@tauli.cat

Facility Information:

Facility Name

Area de Critics. Hospital de Sabadell

City

Sabadell

State/Province

Barcelona

ZIP/Postal Code

08208

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gemma Goma, RN

Phone

937231010

Ext

21179

ggoma@tauli.cat

First Name & Middle Initial & Last Name & Degree

Xaime Garcia, MD

First Name & Middle Initial & Last Name & Degree

Guillem Gruartmoner, MD

12. IPD Sharing Statement

Links:

URL

http://www.edusepsis.org/proyectos_fic.php?id_pro=10

Description

Spanish webpage of the study

Learn more about this trial

Monitoring Resuscitation in Severe Sepsis and Septic Shock

We'll reach out to this number within 24 hrs