Hospital Hyperglycemia, Post-transplant Hyperglycemia
Conditions
Keywords
liver transplant, high blood sugars, hospital hyperglycemia, post-transplant hyperglycemia, post liver transplant, post liver-kidney transplant
Brief summary
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.
Interventions
OTHERIntensive glycemic management
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.
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.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Conduct a randomized controlled trial to compare outcomes with two management strategies to control hospital hyperglycemia in adult patients following liver transplantation. | 90 days 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. |
Secondary
| Measure | 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. |
Countries
United States
Outcome results
None listed