Insulin Therapy for Postreperfusion Hyperglycemia

NCT03152890 | Recruiting Phase 4 DMC

• 1 other identifier: Insulin_LTPL
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperglycaemia (Diabetic); Liver Transplantation

Keywords

Insulin; Liver transplantation; Hyperglycemia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Study group

EXPERIMENTAL

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

Drug: Insulin

Interventions

Insulin DRUG

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.

Study group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• pediatric patients

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-799, South Korea

RECRUITING

MeSH Terms

Conditions

Hyperglycemia; Insulin Resistance

Interventions

Insulin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Chul-Woo Jung, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chul-Woo Jung, MD, PhD

CONTACT

82-2-2072-0640; jungcwoo@gmail.com

Hyung-Chul Lee, MD

CONTACT

82-2-2072-2467; lucid80@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

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

Study Record Dates

• First Submitted: May 3, 2017
• First Posted: May 15, 2017
• Study Start: May 15, 2017
• Primary Completion: December 15, 2024
• Study Completion: December 31, 2024
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)