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Insulin Therapy for Postreperfusion Hyperglycemia (INS_LTPL)

Primary Purpose

Hyperglycaemia (Diabetic), Liver Transplantation

Status
Recruiting
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Insulin
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperglycaemia (Diabetic) focused on measuring Insulin, Liver transplantation, Hyperglycemia

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • pediatric patients

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study group

Arm Description

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

Outcomes

Primary Outcome Measures

Change of blood glucose level 20 minutes after insulin administration
Insulin is administered immediately after baseline hyperglycemia (blood glucose >180 mg/dL) has been observed. Change of blood glucose level after insulin administration is calculated as (baseline glucose - glucose after insulin administration).

Secondary Outcome Measures

Full Information

First Posted
May 3, 2017
Last Updated
April 10, 2023
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03152890
Brief Title
Insulin Therapy for Postreperfusion Hyperglycemia
Acronym
INS_LTPL
Official Title
Insulin Therapy for Postreperfusion Hyperglycemia in Liver Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2017 (Actual)
Primary Completion Date
December 15, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycaemia (Diabetic), Liver Transplantation
Keywords
Insulin, Liver transplantation, Hyperglycemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
The study group receives a linear mixed effects model-proposed dose of insulin when hyperglycemia is noticed after reperfusion of liver graft.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
The study group receives a linear mixed effects model-proposed dose of insulin when hyperglycemia is noticed after reperfusion of liver graft.
Intervention Type
Drug
Intervention Name(s)
Insulin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of blood glucose level 20 minutes after insulin administration
Description
Insulin is administered immediately after baseline hyperglycemia (blood glucose >180 mg/dL) has been observed. Change of blood glucose level after insulin administration is calculated as (baseline glucose - glucose after insulin administration).
Time Frame
20 minutes after insulin administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Liver recipients who showed hyperglycemia (blood glucose >180mg/dL) after reperfusion of liver graft. Exclusion Criteria: pediatric patients
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chul-Woo Jung, MD, PhD
Phone
82-2-2072-0640
Email
jungcwoo@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hyung-Chul Lee, MD
Phone
82-2-2072-2467
Email
lucid80@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chul-Woo Jung, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-799
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeong-Hwa Hong, MD
Phone
82-2-740-8096
Email
jhhong@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Chul-Woo Jung, MD. PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Insulin Therapy for Postreperfusion Hyperglycemia

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