Restrictive Versus Liberal Red Blood Cell Transfusion in Patients of Cirrhosis With Septic Shock

Restrictive Versus Liberal Red Blood Cell Transfusion in Patients of Cirrhosis With Septic Shock: An Open Label Randomized Controlled Trial

Consecutive cirrhotics who present to emergency department of ILBS with documented or suspected sepsis induced hypotension with Hb <8 gm/dl will be randomly assigned to restrictive (Target Hb 7-8 gm/dl) to liberal (Target Hb 10-11 gm/dl) group in a 1:1 proportion At admission, all patients will undergo physical examination and baseline investigations to identify site of sepsis. Enrolled patients will be given PRBC-transfusion (Not more than two units of PRBC/day) when they reach their assigned trigger value (Hb 7-8 g/dl or 10-11 g/dl ) during the entire ICU stay. All other interventions will be at the discretion of clinicians.

Study Overview

• Status: Withdrawn
• Conditions: Cirrhosis
• Intervention / Treatment: Biological: Liberal; Other: Restrictive

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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. Cirrhosis with septic shock.
2. Age >18 years

Exclusion Criteria:

1. Previous severe adverse reaction with blood products,
2. Disseminated intravascular coagulopathy
3. HCC
4. Pregnancy
5. Malignancy
6. Active gastrointestinal bleeding
7. Intracranial bleeding
8. Chronic Kidney disease with Maintenance Hemodialysis
9. Pulmonary Edema
10. Congestive Heart Failure
11. Lack of informed consent

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Liberal; 2 PRBC /day to maintain the target of Hemoglobin 10 to 11 gm/dL. PRBC will be given intravenously at least for 28 days	Biological: Liberal; 2 PRBC /day to maintain the target of Hemoglobin 10 to 11 gm/dL. PRBC will be given intravenously at least for 28 days
Active Comparator: Restrictive; To maintain the target Hemoglobin of 7 to 8 gm/dL.	Other: Restrictive; To maintain the target Hemoglobin of 7 to 8 gm/dL.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mortality in both groups	28 dyas

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in vasopressors in both groups	Improvement is defined as tapering the dose of vasopressors	28 days
Incidence of complications in both groups		28 days
Length of ICU (Intensive Care Unit) stay		28 days
Requirement of mechanical ventilation in both groups		28 days

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Study record dates

Study Major Dates

• Study Start (Anticipated): December 15, 2018
• Primary Completion (Anticipated): February 15, 2019
• Study Completion (Anticipated): February 15, 2019

Study Registration Dates

• First Submitted: February 8, 2018
• First Submitted That Met QC Criteria: February 13, 2018
• First Posted (Actual): February 14, 2018

Study Record Updates

• Last Update Posted (Actual): November 5, 2019
• Last Update Submitted That Met QC Criteria: November 1, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: ILBS-cirrhosis-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No