Intensive Glycemic Management and Outcomes Following Liver Transplantation

Study Overview
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Brief Summary
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Most people develop high blood sugars following liver transplant that requires treatment with insulin in the hospital, even if they don't have diabetes, due to stress and use of steroid medications. High blood sugar levels can be treated with a hormone that the body makes called insulin. This study is being done to determine if maintaining normal blood sugar levels after transplant for as long as needed while in the hospital results in a lesser incidence of death, infections, transplanted liver rejection or failure or need for rehospitalization within 90 days after transplant.

Official Title
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Intensive Glycemic Management and Outcomes Following Liver Transplantation: A Randomized Controlled Trial

Conditions
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Hospital Hyperglycemia, Post-transplant Hyperglycemia

Intervention / Treatment
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* Other: Intensive glycemic management
* Other: Conventional management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age and older Undergoing liver transplant or combined liver-kidney transplant Exclusion Criteria: Unable to grant informed consent or comply with study procedure Allergic to any of the excipients in insulin

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intensive glycemic management<br>Multifaceted approach to achieve strict glucose goals of 90 to 120 mg/dL in the ICU and hospital wards. | Other: Intensive glycemic management<br>* Intravenous insulin infusion, strict dietary intervention, carbohydrate matched subcutaneous insulin therapy. This is a multifaceted approach to achieve strict glucose goals of 90 to 120 mg/dL in the ICU and hospital wards.<br>|
| Active Comparator: Conventional management<br>Conventional treatment to control hyperglycemia with a target glucose goal of 120 to 150 mg/dL in the ICU and 140 to 180 mg/dL on the hospital floors. | Other: Conventional management<br>* Conventional treatment to control hyperglycemia with a target glucose goal of 120 to 150 mg/dL in the ICU and 140 to 180 mg/dL on the hospital floors.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conduct a randomized controlled trial to compare outcomes with two management strategies to control hospital hyperglycemia in adult patients following liver transplantation. | The primary outcome is a 90 day composite of mortality by any cause, graft failure, rejection, infections, and rehospitalization following liver transplantation. | 90 days following liver transplantation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare length of stay in the ICU and hospital in the two study groups. |  | 90 days following liver transplantation. | 
| Compare the incidence of hypoglycemia in the ICU and hospital in the two study groups. |  | 90 days following liver transplantation. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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liver transplant, high blood sugars, hospital hyperglycemia, post-transplant hyperglycemia, post liver transplant, post liver-kidney transplant