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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive glycemic management | Active Comparator | Multifaceted approach to achieve strict glucose goals of 90 to 120 mg/dL in the ICU and hospital wards. |
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| Conventional management | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive glycemic management | Other | 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. |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gunjan Y. Gandhi, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Jacksonville | Florida | 32224 | United States |
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| Conventional management | Other | 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. |
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