We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intensive Glycemic Management and Outcomes Following Liver Transplantation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01432093
First Posted: September 12, 2011
Last Update Posted: November 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gunjan Gandhi, Mayo Clinic
  Purpose
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.

Condition Intervention
Hospital Hyperglycemia Post-transplant Hyperglycemia Other: Intensive glycemic management Other: Conventional management

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intensive Glycemic Management and Outcomes Following Liver Transplantation: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Gunjan Gandhi, Mayo Clinic:

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. [ 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 Outcome Measures:
  • Compare length of stay in the ICU and hospital in the two study groups. [ Time Frame: 90 days following liver transplantation. ]
  • Compare the incidence of hypoglycemia in the ICU and hospital in the two study groups. [ Time Frame: 90 days following liver transplantation. ]

Enrollment: 270
Study Start Date: October 2011
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intensive glycemic management
Multifaceted approach to achieve strict glucose goals of 90 to 120 mg/dL in the ICU and hospital wards.
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.
Active Comparator: 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.
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01432093


Locations
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Gunjan Y. Gandhi, MD Mayo Clinic
  More Information

Responsible Party: Gunjan Gandhi, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01432093     History of Changes
Other Study ID Numbers: 11-002918
First Submitted: September 7, 2011
First Posted: September 12, 2011
Last Update Posted: November 13, 2013
Last Verified: November 2013

Keywords provided by Gunjan Gandhi, Mayo Clinic:
liver transplant
high blood sugars
hospital hyperglycemia
post-transplant hyperglycemia
post liver transplant
post liver-kidney transplant

Additional relevant MeSH terms:
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases


To Top