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Intensive Glycemic Management and Outcomes Following Liver Transplantation

NCT ID: NCT01432093

Last Updated: 2013-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hospital Hyperglycemia Post-transplant Hyperglycemia

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intensive glycemic management

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

Group Type ACTIVE_COMPARATOR

Intensive glycemic management

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

Conventional management

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Gunjan Gandhi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gunjan Y. Gandhi, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Jacksonville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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11-002918

Identifier Type: -

Identifier Source: org_study_id