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

Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03433508
• Other study ID #: ILBS-cirrhosis-01
• Status: Withdrawn
• Phase: N/A
• Start date: December 15, 2018
• Est. completion date: February 15, 2019

Study information

• Verified date: October 2019
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 15, 2019
• Est. primary completion date: February 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis
• Liver Cirrhosis
• Shock, Septic

Intervention

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

Other:
• Restrictive
To maintain the target Hemoglobin of 7 to 8 gm/dL.

Locations

Country	Name	City	State
India	Institute of Liver and Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality in both groups		28 dyas
Secondary	Improvement in vasopressors in both groups	Improvement is defined as tapering the dose of vasopressors	28 days
Secondary	Incidence of complications in both groups		28 days
Secondary	Length of ICU (Intensive Care Unit) stay		28 days
Secondary	Requirement of mechanical ventilation in both groups		28 days