Comparison of 9 Doses vs 3 Doses of Post Operative Antibiotics in Live Liver Donors

NCT03765645 | Completed

• 1 other identifier: ILBS Liver Transplant 001
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

Antibiotic resistance is a very serious and dangerous situation in modern world. Judicious use of antibiotics is therefore of extreme importance not just in preventing antibiotic resistance but also it decreases cost of the treatment and prevent side-effects of the antibiotics. No randomized trial is available in literature for antibiotic prophylaxis in patient undergoing donor hepatectomy. Currently, antibiotic regimen is based on individual institutional protocol. There have been studies, comparing short course vs long dose of antibiotics in hepatectomy patients, concluding equivalent efficacy in preventing infective complications. The investigators aim at proving that 3 doses of antibiotics are equally effective in preventing infective complications, when compared to 9 doses of antibiotics, in patients undergoing donor hepatectomy. So, a randomized trial is required to study the antibiotic duration in patient undergoing donor hepatectomy.

Conditions

Antibiotic Prophylaxis; Postoperative Infection

Keywords

Liver Transplant; Donor Hepatectomy; Antibiotic prophylaxis

Outcome Measures

Primary Outcomes (1)

• Incidence of infective complications

  The number of infective complications (CDC guidelines) in post operative period will be compared among patients receiving 3 doses vs patients receiving 9 doses of antibiotics.

  1 year

Study Arms (2)

3 doses on intra venous antibiotics

ACTIVE COMPARATOR

Patients will receive 3 doses of intra venous antibiotics. (1 dose preoperative, 1 intra operative and 1 post-operative)

Drug: Piperacillin + Tazobactam

9 doses of intra venous antibiotics

ACTIVE COMPARATOR

Patients will receive 9 doses of intra venous antibiotics. (1 dose preoperative, rest 8 doses at equal intervals)

Drug: Piperacillin + Tazobactam

Interventions

Piperacillin + Tazobactam DRUG

Antibiotic used will be Piperacillin + Tazobactam Dose: 4.5 g, thrice a day at regular intervals Route: Intra-venous

3 doses on intra venous antibiotics; 9 doses of intra venous antibiotics

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• All patient undergoing donor hepatectomy consent for the study

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

ILBS

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

Location

MeSH Terms

Interventions

Piperacillin, Tazobactam Drug Combination

Intervention Hierarchy (Ancestors)

Tazobactam; Penicillanic Acid; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Piperacillin; Ampicillin; Penicillin G; Sulfur Compounds; Sulfones; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Dr. Viniyendra Pamecha

  ILBS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2018
• First Posted: December 5, 2018
• Study Start: October 4, 2018
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: February 4, 2021

Record last verified: 2020-02

Locations

IN (1)