Clinical Trials Logo

Clinical Trial Summary

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


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT05109156
Study type Observational
Source Institute of Liver and Biliary Sciences, India
Contact Bharat Nair, MBBS, MS,MRCS
Phone +91-8373926785
Email bharatarcher1@gmail.com
Status Recruiting
Phase
Start date November 5, 2021
Completion date April 2022

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05095324 - The Biomarker Prediction Model of Septic Risk in Infected Patients
Completed NCT02714595 - Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens Phase 3
Completed NCT03644030 - Phase Angle, Lean Body Mass Index and Tissue Edema and Immediate Outcome of Cardiac Surgery Patients
Completed NCT02867267 - The Efficacy and Safety of Ta1 for Sepsis Phase 3
Completed NCT04804306 - Sepsis Post Market Clinical Utility Simple Endpoint Study - HUMC
Recruiting NCT05578196 - Fecal Microbial Transplantation in Critically Ill Patients With Severe Infections. N/A
Terminated NCT04117568 - The Role of Emergency Neutrophils and Glycans in Postoperative and Septic Patients
Completed NCT03550794 - Thiamine as a Renal Protective Agent in Septic Shock Phase 2
Completed NCT04332861 - Evaluation of Infection in Obstructing Urolithiasis
Completed NCT04227652 - Control of Fever in Septic Patients N/A
Enrolling by invitation NCT05052203 - Researching the Effects of Sepsis on Quality Of Life, Vitality, Epigenome and Gene Expression During RecoverY From Sepsis
Terminated NCT03335124 - The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock Phase 4
Recruiting NCT04005001 - Machine Learning Sepsis Alert Notification Using Clinical Data Phase 2
Completed NCT03258684 - Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Sepsis and Septic Shock N/A
Recruiting NCT05217836 - Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.
Completed NCT05018546 - Safety and Efficacy of Different Irrigation System in Retrograde Intrarenal Surgery N/A
Completed NCT03295825 - Heparin Binding Protein in Early Sepsis Diagnosis N/A
Not yet recruiting NCT06045130 - PUFAs in Preterm Infants
Not yet recruiting NCT05361135 - 18-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in S. Aureus Bacteraemia N/A
Not yet recruiting NCT05443854 - Impact of Aminoglycosides-based Antibiotics Combination and Protective Isolation on Outcomes in Critically-ill Neutropenic Patients With Sepsis: (Combination-Lock01) Phase 3