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

NCT02462902 | Completed

• 1 other identifier: ILBS-Cirrhosis with sepsis-01
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 1

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).

Conditions

Cirrhosis With Septic Shock

Outcome Measures

Primary Outcomes (1)

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

  3 hours

Secondary Outcomes (3)

• Change in lactate dynamics

  3 hours

• Total number of patients with Urine output >/= 0.5mL/kg/hr.

  3 hours

• Mortality

  7 days

Study Arms (2)

5% albumin Infusion

EXPERIMENTAL

(250 ml over 15 to 30 minutes)

Drug: 5% albumin Infusion

0.9% sodium chloride solution

ACTIVE COMPARATOR

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

Drug: 0.9% sodium chloride solution

Interventions

5% albumin Infusion DRUG

colloid, 5% albumin (250 ml over 15 to 30 minutes).

5% albumin Infusion

0.9% sodium chloride solution DRUG

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

0.9% sodium chloride solution

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2015
• First Posted: June 4, 2015
• Study Start: February 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: December 30, 2015

Record last verified: 2015-05

Locations

IN (1)