Study Stopped
lack of funds
Restrictive Versus Liberal Red Blood Cell Transfusion in Patients of Cirrhosis With Septic Shock
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 8, 2018
CompletedFirst Posted
Study publicly available on registry
February 14, 2018
CompletedStudy Start
First participant enrolled
December 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2019
CompletedNovember 5, 2019
October 1, 2019
2 months
February 8, 2018
November 1, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Mortality in both groups
28 dyas
Secondary Outcomes (4)
Improvement in vasopressors in both groups
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
Study Arms (2)
Liberal
EXPERIMENTAL2 PRBC /day to maintain the target of Hemoglobin 10 to 11 gm/dL. PRBC will be given intravenously at least for 28 days
Restrictive
ACTIVE COMPARATORTo maintain the target Hemoglobin of 7 to 8 gm/dL.
Interventions
2 PRBC /day to maintain the target of Hemoglobin 10 to 11 gm/dL. PRBC will be given intravenously at least for 28 days
Eligibility Criteria
You may qualify if:
- Cirrhosis with septic shock.
- Age \>18 years
You may not qualify if:
- Previous severe adverse reaction with blood products,
- Disseminated intravascular coagulopathy
- HCC
- Pregnancy
- Malignancy
- Active gastrointestinal bleeding
- Intracranial bleeding
- Chronic Kidney disease with Maintenance Hemodialysis
- Pulmonary Edema
- Congestive Heart Failure
- Lack of informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
February 8, 2018
First Posted
February 14, 2018
Study Start
December 15, 2018
Primary Completion
February 15, 2019
Study Completion
February 15, 2019
Last Updated
November 5, 2019
Record last verified: 2019-10