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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05109156
Enrollment
500
Registered
2021-11-05
Start date
2021-11-05
Completion date
2022-04-30
Last updated
2022-01-26

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

Conditions

Liver Transplant; Complications, Sepsis

Keywords

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

Brief summary

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

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.

Interventions

OTHERThis is an observational study

This is an observational study

Sponsors

Institute of Liver and Biliary Sciences, India
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 70 Years
Healthy volunteers
No

Inclusion criteria

All patients who undergo living donor liver transplant. \-

Exclusion criteria

Acute Liver Failure

Design outcomes

Primary

MeasureTime frameDescription
Correlation of timeline of sepsis with recipient outcome following Live donor liver transplant.30 daysa. 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

Secondary

MeasureTime frameDescription
study the correlation between recipient liver capsular and peritoneal macrophage activity and preoperative sepsis timeline, profile as well as post operative recipient outcome.30 daysstudy the correlation between recipient liver capsular and peritoneal macrophage activity and preoperative sepsis timeline, profile as well as post operative recipient outcome.

Countries

India

Contacts

Primary ContactBharat Nair, MBBS, MS,MRCS
bharatarcher1@gmail.com+91-8373926785

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026