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Study of Glycemic Control on Liver Transplantation Outcomes

NCT ID: NCT01211730

Last Updated: 2016-12-23

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2016-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Evidence of Liver Transplantation Hyperglycemia Rejection

Keywords

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Liver transplantation Glucose Hyperglycemia Insulin Rejection Hypoglycemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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140 Group

Insulin treatment to target blood glucose at 140 mg/dl

Group Type ACTIVE_COMPARATOR

Insulin

Intervention Type DRUG

Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit.

180 Group

Insulin treatment to target blood glucose at 180 mg/dl

Group Type ACTIVE_COMPARATOR

Insulin

Intervention Type DRUG

Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit.

Interventions

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Insulin

Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit.

Intervention Type DRUG

Other Intervention Names

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glargine insulin aspart insulin Lantus insulin Novolog insulin Detemir insulin Levemir insulin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Mark Molitch

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mark E Molitch, M.D.

Role: PRINCIPAL_INVESTIGATOR

Northwestern University Feinberg School of Medicine

Locations

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Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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Bellon F, Sola I, Gimenez-Perez G, Hernandez M, Metzendorf MI, Rubinat E, Mauricio D. Perioperative glycaemic control for people with diabetes undergoing surgery. Cochrane Database Syst Rev. 2023 Aug 1;8(8):CD007315. doi: 10.1002/14651858.CD007315.pub3.

Reference Type DERIVED
PMID: 37526194 (View on PubMed)

Other Identifiers

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STU00005806

Identifier Type: -

Identifier Source: org_study_id