Improvement in low blood pressure and its outcomes due to severe infections by using normal saline fluid versus human albumin fluid in patients with cirrhosis

Not Applicable

Completed

• Conditions: Health Condition 1: null- Cirrhosis Patients With Sepsis Induced HypotensionHealth Condition 2: K746- Other and unspecified cirrhosis ofliver

• Registration Number: CTRI/2016/09/007246
• Lead Sponsor: Institute of liver and Biliary Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2015-06-30
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 308

Inclusion Criteria

1) Cirrhotic patients of any aetiology with Infection - suspected or documented and Mean arterial pressure less than 65 mm of Hg or systolic blood pressure

Exclusion Criteria

1)Cirrhosis patients in septic shock who are already on vasopressors and/or inotropes

2)Cirrhosis patients in septic shock with structural heart disease

3)Cirrhosis patients in septic shock with chronic renal failure/dialysis dependent/volume overloaded state

4)Cirrhosis patients in shock, caused by other reasons, other than septic shock

5)Cirrhosis patients in septic shock in whom contraindication to internal jugular or subclavian line insertion is present

6)Age less than 18 years

7)Previous episode of septic shock during the same hospital stay

8)Pregnant or lactating women

9)Patients in need for emergent surgical interventions

10)Cirrhosis patients in septic shock with chronic obstructive lung disease and right heart failure

11)Cirrhosis patients in septic shock with associated upper gastrointestinal bleed or coagulopathy related bleed with a haemoglobin of less than 8g/dL or requiring urgent transfusions of blood and blood products

12)A previous adverse reaction to human albumin solution

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total number of patients with MAP (Mean Arterial Pressure) 65 .Timepoint: 3 hours

Secondary Outcome Measures

Name	Time	Method
MortalityTimepoint: 7 days;Total number of patients with serum lactate less than 1 or 20% reduction from baselineTimepoint: 3 hours;Total number of patients with Urine output more than or eqals to 0.5mL/kg/hr.Timepoint: 3 hours