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OpenTrials
Completed

NCT Number: NCT01432093

Intensive Glycemic Management and Outcomes Following Liver Transplantation

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.

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Key information

Conditions

Hospital Hyperglycemia Post-transplant Hyperglycemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intensive glycemic management

Other

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

Other

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 outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 90 days following liver transplantation.

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

    Time frame: 90 days following liver transplantation.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 12, 2011
Registry last updated
Nov 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.