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Completed

NCT Number: NCT02462902

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

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).

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Key information

Conditions

Cirrhosis With Septic Shock

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Cirrhosis patients in septic shock who are already on vasopressors and/or inotropes
  • Cirrhosis patients in septic shock with structural heart disease
  • Cirrhosis patients in septic shock with chronic renal failure/dialysis dependent/volume overloaded state
  • Cirrhosis patients in shock, caused by other reasons, other than septic shock
  • Cirrhosis patients in septic shock in whom contraindication to internal jugular or subclavian line insertion is present
  • Age less than 18 years
  • Previous episode of septic shock during the same hospital stay
  • Pregnant or lactating women
  • Patients in need for emergent surgical interventions
  • Cirrhosis patients in septic shock with chronic obstructive lung disease and right heart failure
  • 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
  • A previous adverse reaction to human albumin solution

Treatment and study plan

5% albumin Infusion

Drug

colloid, 5% albumin (250 ml over 15 to 30 minutes).

0.9% sodium chloride solution

Drug

0.9% sodium chloride solution (total of 30ml/kg over 15 to 30 minutes)

Primary outcomes

  1. Total number of patients with MAP (Mean Arterial Pressure) ≥ 65

    Time frame: 3 hours

Secondary outcomes

  1. Change in lactate dynamics

    Time frame: 3 hours

  2. Total number of patients with Urine output >/= 0.5mL/kg/hr.

    Time frame: 3 hours

  3. Mortality

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 4, 2015
Registry last updated
Dec 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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