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

Institute of Liver and Biliary Sciences, India

Status: Withdrawn

Conditions: Cirrhosis

Treatments: Biological: Liberal; Other: Restrictive

Study type: Interventional

Funder types: Other

Identifiers

NCT03433508

ILBS-cirrhosis-01

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Liberal

Experimental group

Description:

2 PRBC /day to maintain the target of Hemoglobin 10 to 11 gm/dL. PRBC will be given intravenously at least for 28 days

Treatment:

Biological: Liberal

Restrictive

Active Comparator group

Description:

To maintain the target Hemoglobin of 7 to 8 gm/dL.

Treatment:

Other: Restrictive