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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03152890
Other study ID # Insulin_LTPL
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date May 15, 2017
Est. completion date December 31, 2024

Study information

Verified date April 2024
Source Seoul National University Hospital
Contact Chul-Woo Jung, MD, PhD
Phone 82-2-2072-0640
Email jungcwoo@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date December 31, 2024
Est. primary completion date December 15, 2024
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - Liver recipients who showed hyperglycemia (blood glucose >180mg/dL) after reperfusion of liver graft. Exclusion Criteria: - pediatric patients

Study Design


Intervention

Drug:
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.

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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).
20 minutes after insulin administration
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