Intensive Glycemic Management and Outcomes Following Liver Transplantation

Mayo Clinic

Status: Completed

Conditions: Post-transplant Hyperglycemia; Hospital Hyperglycemia

Treatments: Other: Intensive glycemic management; Other: Conventional management

Study type: Interventional

Funder types: Other

Identifiers

NCT01432093

11-002918

Details and patient eligibility

About

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.

Enrollment: 270 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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270 participants in 2 patient groups

Intensive glycemic management

Active Comparator group

Description:

Multifaceted approach to achieve strict glucose goals of 90 to 120 mg/dL in the ICU and hospital wards.

Treatment:

Other: Intensive glycemic management

Conventional management

Active Comparator group

Description:

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.

Treatment:

Other: Conventional management