Insulin Therapy for Postreperfusion Hyperglycemia

NCT ID: NCT03152890

Last Updated: 2024-04-19

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

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-15

Study Completion Date

2024-12-31

Brief Summary

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Glycemic control during liver transplantation is challenging especially after reperfusion of the liver graft. Insulin dose to treat postreperfusion hyperglycemia is retrospectively analyzed using historical data. The proposed dose then is prospectively applied to the patients to assess the adequacy of the insulin dose.

Detailed Description

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Hyperglycemia is common during liver transplantation ,especially after graft reperfusion. Response to insulin is frequently unpredictable during postreperfusion period with no consensus or guidelines on glycemic control. The primary aim of this mixed retrospective/prospective study is to investigate the optimal insulin dose to treat hyperglycemia during the postreperfusion period of liver transplantation.

In the retrospective study, adult liver recipients (\>18 years old) who underwent liver transplantation between 2004 and 2016 are reviewed. Delta glucose is the primary outcome variable defined as the difference in blood glucose levels before and after insulin administration. The relationship between the insulin dose and delta glucose is analyzed with a linear mixed effects analysis to find the optimal insulin dose to treat postreperfusion hyperglycemia.

In the prospective trial, the proposed insulin dose is administered to the patient who showed hyperglycemia after graft reperfusion. The frequency and magnitude of glucose reduction is the primary outcome. The secondary outcome is the incidence and degree of hypoglycemia.

Conditions

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Hyperglycaemia (Diabetic) Liver Transplantation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The study group receives a linear mixed effects model-proposed dose of insulin when hyperglycemia is noticed after reperfusion of liver graft.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Study group

The study group receives a linear mixed effects model-proposed dose of insulin when hyperglycemia is noticed after reperfusion of liver graft.

Group Type EXPERIMENTAL

Insulin

Intervention Type DRUG

If blood glucose level after reperfusion of liver graft exceeds 180 mg/dL, the insulin dose proposed by the linear mixed effects analysis is given as a bolus.

Interventions

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Insulin

If blood glucose level after reperfusion of liver graft exceeds 180 mg/dL, the insulin dose proposed by the linear mixed effects analysis is given as a bolus.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Liver recipients who showed hyperglycemia (blood glucose \>180mg/dL) after reperfusion of liver graft.

Exclusion Criteria

* pediatric patients
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chul-Woo Jung

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chul-Woo Jung, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Chul-Woo Jung, MD, PhD

Role: CONTACT

82-2-2072-0640

Hyung-Chul Lee, MD

Role: CONTACT

82-2-2072-2467

Facility Contacts

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Jeong-Hwa Hong, MD

Role: primary

82-2-740-8096

Other Identifiers

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Insulin_LTPL

Identifier Type: -

Identifier Source: org_study_id

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