Cirrhosis
Conditions
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.
Interventions
BIOLOGICALLiberal
2 PRBC /day to maintain the target of Hemoglobin 10 to 11 gm/dL. PRBC will be given intravenously at least for 28 days
OTHERRestrictive
To maintain the target Hemoglobin of 7 to 8 gm/dL.
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mortality in both groups | 28 dyas |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in vasopressors in both groups | 28 days | Improvement is defined as tapering the dose of vasopressors |
| 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 | — |
Countries
India
Outcome results
None listed