Comparison And Outcomes Of Fluid Resucitation With 0.9% Normal Saline And 5% Albumin In Cirrhosis Patients With Sepsis Induced Hypotension

Cirrhosis With Septic Shock Clinical Trial

Official title:

Comparison And Outcomes Of Fluid Resucitation With 0.9% Normal Saline And 5% Albumin In Cirrhosis Patients With Sepsis Induced Hypotension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02462902
• Other study ID #: ILBS-Cirrhosis with sepsis-01
• Status: Completed
• Phase: N/A
• First received: May 25, 2015
• Last updated: December 29, 2015
• Start date: February 2014
• Est. completion date: June 2015

Study information

• Verified date: May 2015
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

300 consecutive patients with cirrhosis of any aetiology admitted with features of sepsis and sepsis induced hypotension to the intensive care unit, the emergency department and the step down units of Institute of Liver and Biliary Sciences, New Delhi, who fulfil the inclusion criteria.

This study will be a single centre prospective randomized comparative trial. Patients will be randomized into two groups. Group A will receive crystalloid, 0.9% sodium chloride solution (total of 30ml/kg over 30 minutes) and Group B will receive colloid, 5% albumin (250 ml over 15 minutes).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 308
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

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

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cirrhosis With Septic Shock
• Hypotension
• Liver Cirrhosis

Intervention

Drug:
• 5% albumin Infusion
colloid, 5% albumin (250 ml over 15 to 30 minutes).
• 0.9% sodium chloride solution
0.9% sodium chloride solution (total of 30ml/kg over 15 to 30 minutes)

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	Total number of patients with MAP (Mean Arterial Pressure) = 65		3 hours	No
Secondary	Change in lactate dynamics		3 hours	No
Secondary	Total number of patients with Urine output >/= 0.5mL/kg/hr.		3 hours	No
Secondary	Mortality		7 days	No