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Comparison of Standard Dose Versus Once a Day Intravenous Albumin in Spontaneous Bacterial Peritonitis

A

All India Institute Of Medical Science (AIIMS)

Status

Completed

Conditions

Cirrhosis

Treatments

Drug: ALBUMIN

Study type

Interventional

Funder types

Other

Identifiers

NCT02756741
AIIMS sbp

Details and patient eligibility

About

The standard recommended management of spontaneous bacterial peritonitis (SBP) includes a third-generation cephalosporin (cefotaxime or ceftriaxone) and high dose albumin (1.5g/kg on day 1 and 1g/kg on day 3). The major drawback of the current recommendations is the high price of albumin. In the current randomized control trial investigators compared the effect of standard recommended dose of albumin (1.5g/kg on day 1 and 1g/kg on day 3) vs. low dose (20g/d for 5 days) on the resolution of SBP and subsequent cytokine changes in ascitic fluid and blood.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Diagnosis of SBP
  2. Age > 18 years
  3. Consent to participate in the trial

Exclusion criteria

  1. Secondary peritonitis
  2. Malignancies including HCC

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups, including a placebo group

STANDARD DOSE
Active Comparator group
Description:
Albumin 1.5gm/kg on day 1 and 1gm/kg on day 3
Treatment:
Drug: ALBUMIN
LOW DOSE
Placebo Comparator group
Description:
Albumin 20g/d for 5 days
Treatment:
Drug: ALBUMIN

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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