Intensive Glycemic Management and Outcomes Following Liver Transplantation

Hospital Hyperglycemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01432093
• Other study ID #: 11-002918
• Status: Completed
• Phase: N/A
• First received: September 7, 2011
• Last updated: November 11, 2013
• Start date: October 2011
• Est. completion date: July 2013

Study information

• Verified date: November 2013
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hospital Hyperglycemia
• Hyperglycemia
• Post-transplant Hyperglycemia

Intervention

Other:
• Intensive 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 management
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.

Locations

Country	Name	City	State
United States	Mayo Clinic	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Compare length of stay in the ICU and hospital in the two study groups.		90 days following liver transplantation.	No
Secondary	Compare the incidence of hypoglycemia in the ICU and hospital in the two study groups.		90 days following liver transplantation.	No