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Completed

NCT Number: NCT02468089

To Compare the Efficacy of Carbepenem Versus Carbepenem Plus GM-CSF in Difficult To Treat Spontaneous Bacterial Peritonitis

A Minimum of 150 consecutive patients of decompensated cirrhosis of any etiology, presenting to the Institute of Liver and Biliary Sciences hospital with a diagnosis of difficult to treat SBP will be included and randomized into two treatment groups.

Group A - Carbepenem+albumin Group B - Carbepenem+albumin+GMCSF.

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Key information

Conditions

Spontaneous Bacterial Peritonitis

Age range

18 year and older

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

  • Age more than 18 years
  • Patients of decompensated liver cirrhosis who present with- Spontaneous bacterial peritonitis (Presence of more than 250 neutrophils per cc of ascetic fluid, in the absence of a surgical abdomen, in the presence of decompensated cirrhosis and portal hypertension) that is not responding to initial therapy- DTT-SBP:
  • Hospital acquired - New onset SBP (Spontaneous bacterial peritonitis) after 48 h of hospitalization.
  • Recurrent SBP - One or more prior episode(s) of SBP in year.
  • Antibiotic resistant - Resistance to 3rd Gen Cephalosporin in last 3 m.
  • Antibiotic non-response -Non-response to 3rd Gen Cephalosporin, sepsis on 3rd Gen Cephalosporin.

Exclusion criteria

  • < 18 years.
  • Advanced HCC (HepatoCellular Carcinoma)
  • Post liver transplant
  • HIV + ve, Immunosuppressive therapy
  • Pregnancy
  • Domiciliary treatment
  • No consent

Treatment and study plan

Carbepenem

Drug

ALBUMIN

Drug

GMCSF (of Granulocyte-Monocyte Colony-Stimulating Factor) .

Drug

Primary outcomes

  1. Total no of patients cured from SBP (Spontaneous Bacterial Peritonitis)

    Time frame: 1 week

Secondary outcomes

  1. Survival at week 2

    Time frame: week 2

  2. Survival at week 4

    Time frame: week 4

  3. Survival at week 12

    Time frame: week 12

  4. Total number of patients develop variceal bleed.

    Time frame: 1 week

  5. Total number of patients develop non-SBP (Spontaneous Bacterial Peritonitis) infections within 1 wk of enrolment.

    Time frame: 1 week

  6. Total number of patients develop HE (Hepatic Encephalopathy).

    Time frame: 1 week

  7. Total number of patients develop AKI (Acute kidney Injury).

    Time frame: 1 week

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Official study title

A Randomized Study to Compare the Efficacy of Carbepenem Versus Carbepenem Plus GM-CSF in Difficult To Treat Spontaneous Bacterial Peritonitis

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 10, 2015
Registry last updated
Nov 6, 2017

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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