Study of Glycemic Control on Liver Transplantation Outcomes
Status: | Active, not recruiting |
---|---|
Conditions: | Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - 80 |
Updated: | 4/21/2016 |
Start Date: | April 2009 |
End Date: | March 2016 |
Prospective, Randomized, Open-Label, Controlled Study to Evaluate the Safety and Efficacy of Intensive Glycemic Control on Outcomes Following Liver Transplantation
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.
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.
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.
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.
Inclusion Criteria:
1. Require Liver Transplantation
2. Age 18 - 80
3. Able to give informed consent personally or via a family member who has appropriate
authorization to do so if patient unconscious.
4. Expected survival following transplantation for > 1 year.
5. Glucose level over 180 mg/dL postoperatively
Exclusion Criteria:
1. Inability of patient or family member to give informed consent
2. Not expected to survive for > 1 year following liver transplantation.
3. Previous liver transplantation
4. Acute liver failure
5. Living related donor
We found this trial at
1
site
303 E Chicago Ave
Chicago, Illinois 60611
Chicago, Illinois 60611
(312) 503-8194

Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
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