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Comparison And Outcomes Of Fluid Resucitation With 0.9% Normal Saline And 5% Albumin In Cirrhosis Patients With Sepsis Induced Hypotension

Primary Purpose

Cirrhosis With Septic Shock

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
5% albumin Infusion
0.9% sodium chloride solution
Sponsored by
Institute of Liver and Biliary Sciences, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cirrhosis With Septic Shock

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Cirrhotic patients of any aetiology with Infection - suspected or documented and Mean arterial pressure less than 65 mm of Hg

Exclusion Criteria:

  1. Cirrhosis patients in septic shock who are already on vasopressors and/or inotropes
  2. Cirrhosis patients in septic shock with structural heart disease
  3. Cirrhosis patients in septic shock with chronic renal failure/dialysis dependent/volume overloaded state
  4. Cirrhosis patients in shock, caused by other reasons, other than septic shock
  5. Cirrhosis patients in septic shock in whom contraindication to internal jugular or subclavian line insertion is present
  6. Age less than 18 years
  7. Previous episode of septic shock during the same hospital stay
  8. Pregnant or lactating women
  9. Patients in need for emergent surgical interventions
  10. Cirrhosis patients in septic shock with chronic obstructive lung disease and right heart failure
  11. Cirrhosis patients in septic shock with associated upper gastrointestinal bleed or coagulopathy related bleed with a haemoglobin of less than 8g/dL or requiring urgent transfusions of blood and blood products
  12. A previous adverse reaction to human albumin solution

Sites / Locations

  • Institute of Liver and Biliary Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

5% albumin Infusion

0.9% sodium chloride solution

Arm Description

(250 ml over 15 to 30 minutes)

0.9% sodium chloride solution (total of 30ml/kg over 15 to 30 minute)

Outcomes

Primary Outcome Measures

Total number of patients with MAP (Mean Arterial Pressure) ≥ 65

Secondary Outcome Measures

Change in lactate dynamics
Total number of patients with Urine output >/= 0.5mL/kg/hr.
Mortality

Full Information

First Posted
May 25, 2015
Last Updated
December 29, 2015
Sponsor
Institute of Liver and Biliary Sciences, India
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1. Study Identification

Unique Protocol Identification Number
NCT02462902
Brief Title
Comparison And Outcomes Of Fluid Resucitation With 0.9% Normal Saline And 5% Albumin In Cirrhosis Patients With Sepsis Induced Hypotension
Official Title
Comparison And Outcomes Of Fluid Resucitation With 0.9% Normal Saline And 5% Albumin In Cirrhosis Patients With Sepsis Induced Hypotension
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
300 consecutive patients with cirrhosis of any aetiology admitted with features of sepsis and sepsis induced hypotension to the intensive care unit, the emergency department and the step down units of Institute of Liver and Biliary Sciences, New Delhi, who fulfil the inclusion criteria. This study will be a single centre prospective randomized comparative trial. Patients will be randomized into two groups. Group A will receive crystalloid, 0.9% sodium chloride solution (total of 30ml/kg over 30 minutes) and Group B will receive colloid, 5% albumin (250 ml over 15 minutes).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis With Septic Shock

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
308 (Actual)

8. Arms, Groups, and Interventions

Arm Title
5% albumin Infusion
Arm Type
Experimental
Arm Description
(250 ml over 15 to 30 minutes)
Arm Title
0.9% sodium chloride solution
Arm Type
Active Comparator
Arm Description
0.9% sodium chloride solution (total of 30ml/kg over 15 to 30 minute)
Intervention Type
Drug
Intervention Name(s)
5% albumin Infusion
Intervention Description
colloid, 5% albumin (250 ml over 15 to 30 minutes).
Intervention Type
Drug
Intervention Name(s)
0.9% sodium chloride solution
Intervention Description
0.9% sodium chloride solution (total of 30ml/kg over 15 to 30 minutes)
Primary Outcome Measure Information:
Title
Total number of patients with MAP (Mean Arterial Pressure) ≥ 65
Time Frame
3 hours
Secondary Outcome Measure Information:
Title
Change in lactate dynamics
Time Frame
3 hours
Title
Total number of patients with Urine output >/= 0.5mL/kg/hr.
Time Frame
3 hours
Title
Mortality
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cirrhotic patients of any aetiology with Infection - suspected or documented and Mean arterial pressure less than 65 mm of Hg Exclusion Criteria: Cirrhosis patients in septic shock who are already on vasopressors and/or inotropes Cirrhosis patients in septic shock with structural heart disease Cirrhosis patients in septic shock with chronic renal failure/dialysis dependent/volume overloaded state Cirrhosis patients in shock, caused by other reasons, other than septic shock Cirrhosis patients in septic shock in whom contraindication to internal jugular or subclavian line insertion is present Age less than 18 years Previous episode of septic shock during the same hospital stay Pregnant or lactating women Patients in need for emergent surgical interventions Cirrhosis patients in septic shock with chronic obstructive lung disease and right heart failure Cirrhosis patients in septic shock with associated upper gastrointestinal bleed or coagulopathy related bleed with a haemoglobin of less than 8g/dL or requiring urgent transfusions of blood and blood products A previous adverse reaction to human albumin solution
Facility Information:
Facility Name
Institute of Liver and Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India

12. IPD Sharing Statement

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Comparison And Outcomes Of Fluid Resucitation With 0.9% Normal Saline And 5% Albumin In Cirrhosis Patients With Sepsis Induced Hypotension

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