Antibiotic ProphylaxisNCT03765645
Comparison of 9 Doses vs 3 Doses of Post Operative Antibiotics in Live Liver Donors
A study testing Piperacillin + Tazobactam in people with Antibiotic Prophylaxis and Postoperative Infection, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Antibiotic Prophylaxis, Postoperative Infection
- What is being tested?
- Piperacillin + Tazobactam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteIndia
- Study dates
- 4 Oct 2018to 31 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All patient undergoing donor hepatectomy consent for the study
Who cannot join
- Patients refusing consent for inclusion in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of 9 Doses vs 3 Doses of Post Operative Antibiotics in Live Liver Donors: A Randomized Controlled Trial
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.
Read the detailed description
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. So, a randomized trial is required to study the antibiotic duration in patient undergoing donor hepatectomy.
The investigators aim to prove that, in preventing infective complications, 3 doses of antibiotics are equally effective as compared to 9 doses of antibiotics in patients of donor hepatectomy.
Methodology:
The present study will be an equivalence randomized control trial where data will be collected from patients who are undergoing donor hepatectomy. Donor evaluation will be done according to institutional protocol. Donor evaluation will be done step wise as tabulated below.
Surgical technique After opening the abdomen through a J-shaped incision, cholecystectomy will be performed and intraoperative cholangiogram will be carried out through the cystic duct stump. The ipsilateral lobe will be mobilized and the hepatic vein will be looped. Hilar dissection will be performed and the ipsilateral portal vein and hepatic artery are defined. The transection plane will be determined by the line of demarcation obtained by temporary clamping of the ipsilateral portal vein and hepatic artery. Parenchymal transection will be performed without inflow occlusion by a Cavitron Ultrasonic Surgical Aspirator (CUSA_; Valleylab, Boulder, CO, USA). The last one-third of the transaction will be performed with a hanging maneuver. After completion of the transaction, the bile duct will be looped along with the sheath and a repeat cholangiogram will be performed by placing radio opaque markers at the proposed bile duct transection site. The bile duct will be divided between the markers. Intravenous heparin will be given (50 IU/kg); after waiting for 3 min, the hepatic artery, portal vein and hepatic vein will be divided between clamps and the graft will be taken out.
Assumptions:
- Prevalence of infective complications with 3 doses of antibiotic: 9%
- Prevalence of infective complications with 9 doses of antibiotic: 7% The alpha error, the power of the study and the equivalence margin will be taken as 5%, 80% and 15% respectively. For this investigators will need to enroll a total of 108 patients, equally divided into 2 groups.
Group A shall include 54 consecutive patients who are undergoing donor hepatectomy. These patients will be followed up closely in the post-operative period and would be serially sampled at pre-defined intervals. Patients will be assessed for infective complications. Antibiotics will be continued beyond 3 doses, if any sign of infection is present (Fever/ TLC more than 11,000/ Wound infection/others).
Group B shall include 54 patients, who will receive antibiotics for 3 days. These patients will also be followed up closely in the post-operative period and would be serially sampled at pre-defined intervals. Patients will be assessed for infective complications. Antibiotics will be continued beyond 3 days, if any sign of infection is present (Fever/ TLC more than 11,000/ Wound infection/others).
Infective complication rates / total duration of antibiotics/ cost of antibiotics and morbidity will be compared between the 2 cohorts.
EXPECTED OUTCOME: To establish that 3 doses of antibiotics are equally effective in preventing infective complications, as compared to 9 doses of antibiotics, in patients undergoing donor hepatectomy.
- Conditions
- Antibiotic Prophylaxis, Postoperative Infection
- Being tested
- Piperacillin + Tazobactam
- Keywords
- Liver Transplant, Donor Hepatectomy, Antibiotic prophylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piperacillin + TazobactamDrug
Antibiotic used will be Piperacillin + Tazobactam Dose: 4.5 g, thrice a day at regular intervals Route: Intra-venous
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Drug: Piperacillin + Tazobactam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start4 Oct 2018
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibiotic ProphylaxisStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Viniyendra Pamecha, Principal investigator, ILBS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03765645
- Sponsor's protocol ID
- ILBS Liver Transplant 001
- Status last verified
- Feb 2020
- First submitted
- 22 Oct 2018
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 9 Doses vs 3 Doses of Post Operative Antibiotics in Live Liver Donors: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03765645
- Acronym / sponsor ID
- ILBS Liver Transplant 001
- Conditions
- Antibiotic Prophylaxis, Postoperative Infection
- Keywords
- Liver Transplant, Donor Hepatectomy, Antibiotic prophylaxis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 4 Oct 2018 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 5 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. So, a randomized trial is required to study the antibiotic duration in patient undergoing donor hepatectomy.
The investigators aim to prove that, in preventing infective complications, 3 doses of antibiotics are equally effective as compared to 9 doses of antibiotics in patients of donor hepatectomy.
Methodology:
The present study will be an equivalence randomized control trial where data will be collected from patients who are undergoing donor hepatectomy. Donor evaluation will be done according to institutional protocol. Donor evaluation will be done step wise as tabulated below.
Surgical technique After opening the abdomen through a J-shaped incision, cholecystectomy will be performed and intraoperative cholangiogram will be carried out through the cystic duct stump. The ipsilateral lobe will be mobilized and the hepatic vein will be looped. Hilar dissection will be performed and the ipsilateral portal vein and hepatic artery are defined. The transection plane will be determined by the line of demarcation obtained by temporary clamping of the ipsilateral portal vein and hepatic artery. Parenchymal transection will be performed without inflow occlusion by a Cavitron Ultrasonic Surgical Aspirator (CUSA_; Valleylab, Boulder, CO, USA). The last one-third of the transaction will be performed with a hanging maneuver. After completion of the transaction, the bile duct will be looped along with the sheath and a repeat cholangiogram will be performed by placing radio opaque markers at the proposed bile duct transection site. The bile duct will be divided between the markers. Intravenous heparin will be given (50 IU/kg); after waiting for 3 min, the hepatic artery, portal vein and hepatic vein will be divided between clamps and the graft will be taken out.
Assumptions:
- Prevalence of infective complications with 3 doses of antibiotic: 9%
- Prevalence of infective complications with 9 doses of antibiotic: 7% The alpha error, the power of the study and the equivalence margin will be taken as 5%, 80% and 15% respectively. For this investigators will need to enroll a total of 108 patients, equally divided into 2 groups.
Group A shall include 54 consecutive patients who are undergoing donor hepatectomy. These patients will be followed up closely in the post-operative period and would be serially sampled at pre-defined intervals. Patients will be assessed for infective complications. Antibiotics will be continued beyond 3 doses, if any sign of infection is present (Fever/ TLC more than 11,000/ Wound infection/others).
Group B shall include 54 patients, who will receive antibiotics for 3 days. These patients will also be followed up closely in the post-operative period and would be serially sampled at pre-defined intervals. Patients will be assessed for infective complications. Antibiotics will be continued beyond 3 days, if any sign of infection is present (Fever/ TLC more than 11,000/ Wound infection/others).
Infective complication rates / total duration of antibiotics/ cost of antibiotics and morbidity will be compared between the 2 cohorts.
EXPECTED OUTCOME: To establish that 3 doses of antibiotics are equally effective in preventing infective complications, as compared to 9 doses of antibiotics, in patients undergoing donor hepatectomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3 doses on intra venous antibiotics | Active comparator | Drug: Piperacillin + TazobactamPatients will receive 3 doses of intra venous antibiotics. (1 dose preoperative, 1 intra operative and 1 post-operative) |
| 9 doses of intra venous antibiotics | Active comparator | Drug: Piperacillin + TazobactamPatients will receive 9 doses of intra venous antibiotics. (1 dose preoperative, rest 8 doses at equal intervals) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All patient undergoing donor hepatectomy consent for the study
Key exclusion criteria (1 listed)
- Patients refusing consent for inclusion in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Piperacillin + TazobactamAntibiotic used will be Piperacillin + Tazobactam Dose: 4.5 g, thrice a day at regular intervals Route: Intra-venous | Drug | 3 doses on intra venous antibiotics, 9 doses of intra venous antibiotics |
Primary outcome
Incidence of infective complications
Time frame: 1 year
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Viniyendra Pamecha principal investigator
ILBS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Piperacillin + Tazobactam in people with Antibiotic Prophylaxis and Postoperative Infection, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of infective complications (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.