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Insulin Therapy for Postreperfusion Hyperglycemia

Insulin Therapy for Postreperfusion Hyperglycemia in Liver Transplantation

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03152890
Acronym
INS_LTPL
Enrollment
20
Registered
2017-05-15
Start date
2017-05-15
Completion date
2024-12-31
Last updated
2024-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperglycaemia (Diabetic), Liver Transplantation

Keywords

Insulin, Liver transplantation, Hyperglycemia

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.

Interventions

DRUGInsulin

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.

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* pediatric patients

Design outcomes

Primary

MeasureTime frameDescription
Change of blood glucose level 20 minutes after insulin administration20 minutes after insulin administrationInsulin 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).

Countries

South Korea

Contacts

Primary ContactChul-Woo Jung, MD, PhD
jungcwoo@gmail.com82-2-2072-0640
Backup ContactHyung-Chul Lee, MD
lucid80@gmail.com82-2-2072-2467

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026