Clinical Trials Logo

Clinical Trial Summary

This clinical observational cohort study assess the loss of albumin from blood circulation during and after liver transplantation by mass balance of albumin. The overall assumption of this method is that if albumin is more diluted than hemoglobin, it must have left the plasma, presumably into the interstitial space. Predictors of albumin leakage will be assessed, including biomarkers of inflammation and of endothelial damage and dysfunction. The sub cohorts children and patients with complications, defined as prolonged postoperative treatment in the intensive care unit, respectively, will be focused in separate publications.


Clinical Trial Description

Background Capillary leakage has been recognized to be associated with surgery and inflammation [Fleck 1985]. In liver transplantation considerable amounts of exogenous albumin is administered to support circulatory stability and a post operative plasma albumin concentration of 25 g/L to facilitate interpretation of immuno suppressive drug concentrations. However, the long term effects of exogenous albumin is not well characterized in the literature, and extravasation might promote edema formation and impair wound healing. In previous studies we have demonstrated the ability of the albumin mass balance method to identify leakage of albumin in major abdominal surgery [Norberg 2016].

In a pilot study in patients undergoing liver transplantation (n=11) we found a net leakage of albumin from plasma of 37 ± 17 g at end of surgery and 48 ± 33 g at postoperative day 3.

The primary aim of the new study is to find if this net leakage is still there at postoperative day 7. We are also looking into predictors of positive albumin shift from plasma including markers of inflammation and endothelial injury or dysfunction. Focus will also be put on the subgroup of children during and after liver transplantation. Finally a subgroup of patients in need of prolonged ICU stay after liver transplantation will be investigated to see the prolonged effects of our present routines, and these patients ability to synthetize albumin.

All patients undergoing liver transplantation at Karolinska University Hospital are eligible.

Recruitment will be made in advance as soon as patients are put on the transplant waiting list. In adults, at the day of surgery, blood samples will be taken repeatedly for estimation of plasma albumin. In all patients we will keep track of any gains or losses of albumin or hemoglobin in suction bottles, drains, exogenous blood products, exogenous albumin etc. This sampling will proceed during the study period that will end at hospital discharge or not later than post-operative day 21. Adult patients that are still in the ICU on postoperative day 3 will be subjected to a measurement of albumin synthesis rate by the flooding method [Ballmer 1993]. All subjects, even children, will have blood sampled for ELISAs of markers of inflammation and endothelial injury or dysfunction.

Total study specific blood sampling will be limited to 100 mL in adults and 6 mL in children. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03441035
Study type Observational
Source Karolinska Institutet
Contact Åke Norberg, Ass Prof
Phone +46739661152
Email ake.norberg@sll.se
Status Recruiting
Phase
Start date March 27, 2018
Completion date June 30, 2021

See also
  Status Clinical Trial Phase
Enrolling by invitation NCT05818644 - Hepatic Artery Stenosis and Thrombosis After Liver Transplantation in Children
Not yet recruiting NCT06041490 - Adjuvant Therapy for High-risk Hepatocellular Carcinoma Post Liver Transplantation Phase 2
Recruiting NCT04443322 - Durvalumab and Lenvatinib in Participants With Locally Advanced and Metastatic Hepatocellular Carcinoma ( Dulect2020-1 ) N/A
Recruiting NCT05081141 - HHV8 and Solid Organ Transplantation
Completed NCT03165916 - Study to Compare the Incidence of Biliary Complications After Liver Transplantation N/A
Withdrawn NCT04216303 - Optimal A1c Control in Post Liver or Combined Liver and Kidney Transplant Recipients Who Have Diabetes Mellitus
Recruiting NCT04506398 - Heterogeneity and Evolution of hepatoceLlular Carcinoma in Post-transplant HCC Recurrence
Not yet recruiting NCT05853484 - Home-based Bimodal Lifestyle Intervention in Patients With Liver Cirrhosis Awaiting Orthotopic Liver Transplantation N/A
Not yet recruiting NCT05036031 - Transplantation for EASL-CLIF and APASL ACLF Patients: a Retrospective Cohort Study
Recruiting NCT05065125 - Clinical Usefulness of Digital Single-operator Cholangioscopy(SpyGlass™) for Post-liver Transplant Anastomotic Stricture
Recruiting NCT06060392 - Effect of Oral Semaglutide on Liver Fat and Body Composition in Liver Transplant Recipients With Diabetes Mellitus N/A
Enrolling by invitation NCT05195944 - Semaglutide vs Sitagliptin Phase 4
Completed NCT05255510 - Risk of Acute Kidney Injury in Living Liver Donor Surgery
Not yet recruiting NCT06048445 - Placement of Biliary Drainage Stent to Prevent Biliary Intestinal Anastomosis After Liver Transplantation in Children
Completed NCT05116748 - COVID19 Vaccine in SOT Adult Recipients
Completed NCT04182256 - Magnetic Spiderman for Preparation of Liver Donation N/A
Recruiting NCT04327427 - Outcome Analysis of Aspirin in Liver Transplantation
Recruiting NCT04477967 - Design and Implementation of the Pediatric Liver Transplantation Biobank
Recruiting NCT05109156 - Preoperative Sepsis Timeline, Profile and Its Association With Recipient Outcome Following Live Donor Liver Transplant
Recruiting NCT06124209 - Use of Fibrin Sealant Patch for Vein Anastomosis During Deceased Donor Liver Transplantation- Randomized Clinical Trial Phase 4