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

Not Applicable

Withdrawn

• Conditions: Cirrhosis
• Interventions: Other: Restrictive; Biological: Liberal

• Registration Number: NCT03433508
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-08
• Study First Submitted QC: 2018-02-13
• Study First Posted: 2018-02-14
• Study Start: 2018-12-15
• Primary Completion: 2019-02-15
• Study Completion: 2019-02-15
• Status Verified: 2019-10
• Last Update Submitted: 2019-11-01
• Last Update Posted: 2019-11-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Restrictive	Restrictive	To maintain the target Hemoglobin of 7 to 8 gm/dL.
Liberal	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

Primary Outcome Measures

Name	Time	Method
Mortality in both groups	28 dyas

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Institute of Liver and Biliary Sciences; 🇮🇳 New Delhi, Delhi, India