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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03433508
Other study ID # ILBS-cirrhosis-01
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


Related Conditions & MeSH terms


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
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