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Intensive Glycemic Management and Outcomes Following Liver Transplantation

NCT01432093 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2013-11-13

No results posted yet for this study

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.

Conditions

  • Hospital Hyperglycemia
  • Post-transplant Hyperglycemia

Interventions

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.

OTHER

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.

Sponsors & Collaborators

Principal Investigators

  • Gunjan Y. Gandhi, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01432093 on ClinicalTrials.gov