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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-15

Study Completion Date

2019-02-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Liberal

Intervention Type BIOLOGICAL

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

Restrictive

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

Group Type ACTIVE_COMPARATOR

Restrictive

Intervention Type OTHER

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

Interventions

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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

Intervention Type BIOLOGICAL

Restrictive

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No