Insulin Therapy for Postreperfusion Hyperglycemia

Liver Transplantation Clinical Trial

— INS_LTPL  

Official title:

Insulin Therapy for Postreperfusion Hyperglycemia in Liver Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03152890
• Other study ID #: Insulin_LTPL
• Status: Recruiting
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Hyperglycaemia (Diabetic)
• Hyperglycemia
• Liver Transplantation

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