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Role of antibiotic in preventing infections in patients with Child A cirrhosis presenting with gastrointestinal bleeding: A randomized controlled trial

Role of antibiotic prophylaxis in preventing infections in patients with Child A cirrhosis during the episode of acute variceal bleeding: A randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/06/033939
Enrollment
180
Registered
2021-06-01
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K74- Fibrosis and cirrhosis of liver

Interventions

Intervention1: ANTIBIOTIC -INJECTION CEFTRIAXONE: IN PATIENTS WITH CHILD A CIRRHOSIS PRESENTING TO EMERGENCY WITH ACUTE VARICEAL BLEED WILL BE RANDOMIZED TO EITHER CEFTRIAXONE ARM OR NO DRUG Control I

Sponsors

NIL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients of Child-A cirrhosis presenting with Acute variceal bleed.

Exclusion criteria

Exclusion criteria: 1) Child-B/C cirrhosis 2) Child-A cirrhosis who have received antibiotics prior to randomisation 3) Child-A cirrhosis who have evidence of infection at presentation 4) Child- A cirrhosis with concomitant hepatocellular carcinoma (HCC) 5) Patients with overt hepatic encephalopathy at presentation 6) AVB in patients with ACLF 7) Patients with renal dysfunction at presentation (serum creatinine >1.5g/dl) 8) Pregnant and lactating females 9) Patients with age 10) COVID -19 positive patients. 11) Refusal to give consent.

Design outcomes

Primary

MeasureTime frame
Comparison of incidence of infections (SBP and non-SBP related) between those receiving and not receiving antibiotic prophylaxisin child A patients presenting with acute variceal bleed during the period of hospitalisation due to AVB.Timepoint: 72 hours

Secondary

MeasureTime frame
Comparison of the following outcomes between antibiotic treated and non-treated patients: 1) 6-week rebleed rate 2) 6-week mortality rate 3) Incidence of failure to control bleed during the index AVB Timepoint: 6 weeks

Countries

India

Contacts

Public ContactANOOP SARAYA

ALL INDIA INSTITUE OF MEDICAL SCIENCES, NEW DELHI

ansaraya@yahoo.com9868397203

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026