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Blood Glucose Control with a Targeted Pharmacotherapy Protocol in Liver Transplant Recipients

Comparison of Blood Glucose Control and Associated Outcomes Using a Targeted Pharmacotherapy Protocol Compared to Current Protocol in Adult Liver Transplant: Non-parallel, Non-randomized Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20241025063493N1
Enrollment
134
Registered
2025-01-03
Start date
2024-10-22
Completion date
Unknown
Last updated
2025-01-08

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

Conditions

Peri-liver transplant hyperglycemia.

Interventions

Intervention 1: Control group: Blood glucose control according to current protocol. Intervention 2: Intervention group: Blood glucose control based on a targeted pharmacotherapy protocol.

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Liver transplant recipients aged 18 to 65 years Deceased donor liver transplant Blood glucose level higher than 140 mg/dL intraoperatively/postoperatively (with or without a history of diabetes)

Exclusion criteria

Exclusion criteria: Recent surgery within the past 30 days before the transplant Multi-organ transplant recipients Participate in other interventional clinical trials simultaneously

Design outcomes

Primary

MeasureTime frame
Comparison of blood glucose control using a targeted pharmacotherapy protocol compared to current protocol. Timepoint: Blood glucose measurement at baseline, during hospitalization (during ICU stay in the pre-protocol phase every 6 hours and in the protocol phase every 1 to 4 hours; during hospitalization in the ward, fasting, before lunch, before dinner, and at bedtime) and after discharge on days 15, 30, 60, and 90. Method of measurement: Blood test (venous blood glucose level) or glucometer (capillary blood glucose level).

Secondary

MeasureTime frame
Comparison of targeted pharmacotherapy protocol with current protocol on the incidence of any infection in liver transplant recipients within 3 months after transplantation. Timepoint: During hospitalization and after discharge on days 15, 30, 60, and 90. Method of measurement: Based on the criteria for each infection, positive culture, antibiotic regimen for more than 3 days, and confirmation by the infectious disease service.;Comparison of targeted pharmacotherapy protocol with current protocol on mechanical ventilation in liver transplant recipients during hospitalization. Timepoint: During hospitalization. Method of measurement: Patient's medical records.;Comparison of targeted pharmacotherapy protocol with current protocol on length of hospitalization in liver transplant recipients. Timepoint: During hospitalization. Method of measurement: Patient's medical records.;Comparison of targeted pharmacotherapy protocol with current protocol on the incidence of acute kidney injury or need for dialysis in liver transplant recipients within 3 months after transplantation. Timepoint: During hospitalization and after discharge on days 15, 30, 60, and 90. Method of measurement: KDIGO criteria.;Comparison of targeted pharmacotherapy protocol with current protocol on the incidence of graft rejection in liver transplant recipients within 3 months after transplantation. Timepoint: During hospitalization and after discharge on days 15, 30, 60, and 90. Method of measurement: An unexplained two times or more of AST/ALT and normalization following 3 days of pulse methylprednisolone, definitive diagnosis and severity of graft rejection by liver biopsy and using Banff criteria.;Comparison of targeted pharmacotherapy protocol with current protocol on the incidence of new-onset diabetes after transplantation in liver transplant recipients. Timepoint: During hospitalization and after discharge on days 15, 30, 60, and 90. Method of measurement: blood glucose level.;Comparison of targete

Countries

Iran (Islamic Republic of)

Contacts

Public ContactYekta Rameshi

Tehran University of Medical Sciences

y.rameshi1375@gmail.com+98 915 220 0507

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026