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Insulin Therapy for Postreperfusion Hyperglycemia

Phase 4
Recruiting
Conditions
Hyperglycaemia (Diabetic)
Liver Transplantation
Interventions
Registration Number
NCT03152890
Lead Sponsor
Seoul National University Hospital
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
20
Inclusion Criteria
  • Liver recipients who showed hyperglycemia (blood glucose >180mg/dL) after reperfusion of liver graft.
Exclusion Criteria
  • pediatric patients

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Study groupInsulinThe study group receives a linear mixed effects model-proposed dose of insulin when hyperglycemia is noticed after reperfusion of liver graft.
Primary Outcome Measures
NameTimeMethod
Change of blood glucose level 20 minutes after insulin administration20 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
NameTimeMethod

Trial Locations

Locations (1)

Seoul National University Hospital

🇰🇷

Seoul, Korea, Republic of

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