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

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