Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611, United States
NCT Number: NCT01211730
Many but not all studies have shown improvement in morbidity and mortality with intensive glycemic management postoperatively. In this study, the investigators propose to determine whether improved glycemic control using intensive insulin treatment immediately postoperatively will improve outcomes in patients undergoing liver transplant using a prospective, controlled, randomized, parallel-group study design targeting two different glucose levels, 140 and 180 mg/dL.
Looking for future studies?
Notify Me18 year–80 year
All sexes
Interventional
Phase 4
Chicago, Illinois, 60611, United States
Many studies have shown improvement in morbidity and mortality with intensive glycemic management postoperatively. However, some recent studies have not been able to reproduce these benefits and have raised the issue of adverse consequences of hypoglycemia associated with intensive therapy. Our own data show an association of increased graft rejection proportional to postoperative glucose levels in patients who have undergone a liver transplant. Preliminary data suggest that this may improved by better glycemic control using the Glucose Management Service here at Northwestern.
In this study, we propose to determine whether improved glycemic control using intensive insulin treatment immediately postoperatively will improve outcomes in patients undergoing liver transplant using a prospective, controlled, randomized, parallel-group study design targeting two different glucose levels, 140 and 180 mg/dL. Postoperative glucose management with insulin will be supervised by the Glucose Management Service as is routine, with the only research aspect being the two different glucose targets and the outcome analysis with liver transplant rejection as the primary outcome and infections and hypoglycemia being the principle secondary outcomes.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit.
Other names: glargine insulin, aspart insulin, Lantus insulin, Novolog insulin, Detemir insulin, Levemir insulin
Time frame: within 1 year of transplantation
Liver transplant rejection determined by either biopsy or clinical criteria (>2x transaminases, clinical decision, treatment with high dose steroids and other anti-rejection medications
Time frame: Within first 3 days following transplantation
Participants experiencing hypoglycemia (glucose < 70 mg/dL) within the first 3- days following transplantation
Time frame: Within 1 year following transplantation
Time frame: Within 1 year following transplantation
Time frame: 1 year following transplantation
Time frame: 1 year
Death following liver transplant between 1 day and 1 year
Northwestern University
Other
Prospective, Randomized, Open-Label, Controlled Study to Evaluate the Safety and Efficacy of Intensive Glycemic Control on Outcomes Following Liver Transplantation
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT01208337
ALEMTUZUMAB, Behavior
View Trial DetailsNCT01022476
Adenocarcinoma, Blood-Borne Infections
Le Kremlin-Bicêtre, France
View Trial DetailsNCT02263703
Arthritis, Arthritis, Juvenile
Sydney, New South Wales, Australia
View Trial DetailsNCT04763096
Evidence of Liver Transplantation
Seoul, South Korea
View Trial Details