Preoperative Sepsis Timeline, Profile and Its Association With Recipient Outcome Following Live Donor Liver Transplant

January 13, 2022 updated by: Institute of Liver and Biliary Sciences, India
Preoperative sepsis timeline, profile and its association with recipient outcome following live donor liver transplant.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Sepsis is a critical factor causing major mortality and morbidity in liver recipients.

  • According to guidelines patients with active infection should be treated before listing, and those who develop infection while on the waiting list should be removed until the infection is cured or has improved with appropriate antimicrobial treatment.
  • Live donor liver transplant (LDLT) in comparison to Deceased Donor Liver Transplant (DDLT) is a more planned surgery. This gives us an opportunity for preoperative optimization and surgery can be timed. In identifying the impact of timing of LDLT wrt. sepsis , major morbidity can be reduced by optimizing/delaying timing of transplant. On the other hand, preoperative optimization may not be as critical as currently thought, and many more patients , currently delisted following sepsis can reap the benefits of a timely transplant. Results will help in better selection of patients as well as better management of pre transplant sepsis. A variety of studies have evaluated the impact of preoperative sepsis at different periods prior to LT on postoperative outcomes but results are widely varied.

The subsets of macrophages in hepatic capsule are known as liver capsular macrophages(LCMs). LCMs recruit neutrophils in response to bacteria reaching the liver capsule .LCM depletion increases liver pathogen load. Further it is also important to study peritoneal macrophages in chronic liver disease . Chronic sterile inflammation, as in nonalcoholic fatty liver disease, is associated with constant release of damage-associated molecular patterns. Continuous activation and recruitment of peritoneal and Liver capsular macrophages may contribute to fibrogenesis under condition of chronic liver diseases. Study of LCMs and PMs could be a landmark study identifying peritoneal macrophages and Liver capsular macrophages as highly mobile cells with a specialized function , with many possible therapeutic applications.The study will be collecting data both prospectively and retrospectively and will involve assessment of association of timeline and profile of preoperative sepsis on mortality and morbidity of liver transplant recipients. Primary objective will be Correlation of timeline of sepsis with recipient outcome following Live donor liver transplant. Outcome parameters will be Post operative sepsis ,In hospital mortality, Hospital stay, ICU stay, Retransfer to ICU, Days on ventilator, Need for tracheostomy/re-intubation, Duration of inotropic support. Secondary objectives To study the impact of source of sepsis on postoperative outcomes, To evaluate the causative organism of sepsis on post operative outcome. To study the correlation between recipient liver capsular and peritoneal macrophage activity and preoperative sepsis timeline, profile as well as post operative recipient outcome. 25 samples will be collected for liver capsular and peritoneal macrophage study.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • India
    • Delhi
      • New Delhi, Delhi, India, 110070
        • Recruiting
        • Institute of Liver and Biliary Sciences
        • Contact:
        • Contact:
          • Ankit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 70 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing/ undergone live donor liver transplant at our institute

Description

Inclusion Criteria:All patients who undergo living donor liver transplant.

-

Exclusion Criteria: Acute Liver Failure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
This is an observational study
Other: This is an observational study
This is an observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of timeline of sepsis with recipient outcome following Live donor liver transplant.
Time Frame: 30 days
a. Post-operative sepsis b. In hospital mortality c. Hospital stay d. ICU stay e. Retransfer to ICU f. Days on ventilator g. Need for tracheostomy/re-intubation h Duration of inotropic support
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
study the correlation between recipient liver capsular and peritoneal macrophage activity and preoperative sepsis timeline, profile as well as post operative recipient outcome.
Time Frame: 30 days
study the correlation between recipient liver capsular and peritoneal macrophage activity and preoperative sepsis timeline, profile as well as post operative recipient outcome.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Liver and Biliary Sciences, India

Investigators

  • Study Director: Viniyendra Pamecha, FEBS, Institute of Liver & Biliary Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 5, 2021

Primary Completion (ANTICIPATED)

February 1, 2022

Study Completion (ANTICIPATED)

April 1, 2022

Study Registration Dates

First Submitted

October 20, 2021

First Submitted That Met QC Criteria

November 4, 2021

First Posted (ACTUAL)

November 5, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 26, 2022

Last Update Submitted That Met QC Criteria

January 13, 2022

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ILBS-Sepsis-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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