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

NCT05109156 | Unknown

• 1 other identifier: ILBS-Sepsis-02
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Preoperative sepsis timeline, profile and its association with recipient outcome following live donor liver transplant.

Conditions

Sepsis; Liver Transplant; Complications

Keywords

Sepsis; Live donor liver transplant(LDLT),; Liver capsular macrophages(LCM); Peritoneal macrophages(PM)

Outcome Measures

Primary Outcomes (1)

• Correlation of timeline of sepsis with recipient outcome following Live donor liver transplant.

  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 Outcomes (1)

• 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

Study Arms (1)

This is an observational study

This is an observational study

Other: This is an observational study

Interventions

This is an observational study OTHER

This is an observational study

This is an observational study

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing/ undergone live donor liver transplant at our institute

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver and Biliary Sciences

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

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Explant liver with be sent for assessment of the subcapsular layer in addition to routine Histo pathological examination (HPE). 20 ml of peritoneal fluid from the recipient will also be collected and processed for analysis of peritoneal macrophages. Samples will then be subjected to flow cytometry for assessment of: 1. Macrophage identification markers: Quantitative assessment . 2. Macrophage Activation markers: Qualitative/ Activation assessment. Density and functionality of both LCM and PM will then be co-related to both pre-LT sepsis timeline and profile as well as post operative recipient outcome . Identification of Macrophage populations using Flow Cytometry and Immunohistochemistry

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Viniyendra Pamecha, FEBS

  Institute of Liver & Biliary Sciences

  STUDY DIRECTOR

Central Study Contacts

Bharat Nair, MBBS, MS,MRCS

CONTACT

+91-8373926785; bharatarcher1@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: November 5, 2021
• Study Start: November 5, 2021
• Primary Completion: February 1, 2022
• Study Completion: April 1, 2022
• Last Updated: January 26, 2022

Record last verified: 2021-10

Locations

IN (1)