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

December 29, 2015 updated by: Institute of Liver and Biliary Sciences, India

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

308

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Delhi
      • New Delhi, Delhi, India, 110070
        • Institute of Liver and Biliary Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 5% albumin Infusion
(250 ml over 15 to 30 minutes)
Drug: 5% albumin Infusion
colloid, 5% albumin (250 ml over 15 to 30 minutes).
Active Comparator: 0.9% sodium chloride solution
0.9% sodium chloride solution (total of 30ml/kg over 15 to 30 minute)
Drug: 0.9% sodium chloride solution
0.9% sodium chloride solution (total of 30ml/kg over 15 to 30 minutes)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total number of patients with MAP (Mean Arterial Pressure) ≥ 65
Time Frame: 3 hours
3 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: 7 days
7 days
Change in lactate dynamics
Time Frame: 3 hours
3 hours
Total number of patients with Urine output >/= 0.5mL/kg/hr.
Time Frame: 3 hours
3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Liver and Biliary Sciences, India

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

May 25, 2015

First Submitted That Met QC Criteria

June 1, 2015

First Posted (Estimate)

June 4, 2015

Study Record Updates

Last Update Posted (Estimate)

December 30, 2015

Last Update Submitted That Met QC Criteria

December 29, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ILBS-Cirrhosis with sepsis-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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