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Intensive Glycemic Management and Outcomes Following Liver Transplantation

Primary Purpose

Hospital Hyperglycemia, Post-transplant Hyperglycemia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Intensive glycemic management

Conventional management

About this trial

This is an interventional treatment trial for Hospital Hyperglycemia focused on measuring liver transplant, high blood sugars, hospital hyperglycemia, post-transplant hyperglycemia, post liver transplant, post liver-kidney transplant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Intensive glycemic management

Conventional management

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Compare length of stay in the ICU and hospital in the two study groups.

Compare the incidence of hypoglycemia in the ICU and hospital in the two study groups.

Full Information

NCT ID

NCT01432093

First Posted

September 7, 2011

Last Updated

November 11, 2013

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT01432093

Brief Title

Intensive Glycemic Management and Outcomes Following Liver Transplantation

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Completed

Study Start Date

October 2011 (undefined)

Primary Completion Date

July 2013 (Actual)

Study Completion Date

July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hospital Hyperglycemia, Post-transplant Hyperglycemia

Keywords

liver transplant, high blood sugars, hospital hyperglycemia, post-transplant hyperglycemia, post liver transplant, post liver-kidney transplant

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

270 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intensive glycemic management

Arm Type

Active Comparator

Arm Description

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

Arm Title

Conventional management

Arm Type

Active Comparator

Arm 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.

Intervention Type

Other

Intervention Name(s)

Intensive glycemic management

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Conventional management

Intervention 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.

Primary Outcome Measure Information:

Title

Conduct a randomized controlled trial to compare outcomes with two management strategies to control hospital hyperglycemia in adult patients following liver transplantation.

Description

The primary outcome is a 90 day composite of mortality by any cause, graft failure, rejection, infections, and rehospitalization following liver transplantation.

Time Frame

90 days following liver transplantation.

Secondary Outcome Measure Information:

Title

Compare length of stay in the ICU and hospital in the two study groups.

Time Frame

90 days following liver transplantation.

Title

Compare the incidence of hypoglycemia in the ICU and hospital in the two study groups.

Time Frame

90 days following liver transplantation.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gunjan Y. Gandhi, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32224

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Intensive Glycemic Management and Outcomes Following Liver Transplantation

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