Pharmacokinetics of tacrolimus in the first days after heart and lung transplantation.
Completed
- Conditions
- transplantationtacrolimuspharmacokinetics
- Registration Number
- NL-OMON20956
- Lead Sponsor
- Prof. J. Meulenbelt, MD, PhDHead of department of National Poisons Information Center Intensive Care Center of the division of Anesthesiology, Intensive Care and Emergency Medicine, University Medical Center of UtrechtP.O. Box 855003508 GA UtrechtThe Netherlands
- Brief Summary
doi.org/10.1007/s13318-019-00591-7, doi.org/10.1007/s40262-019-00854-1
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
1. Patients ≥ 18 years;
2. Patients admitted to the ICC of UMCU after heart or lung transplantation;
Exclusion Criteria
1. Patients < 18 years;
2. Patients who die within one day after admission to the ICC of UMCU;
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To show the greater variability of tacrolimus whole blood total and unbound plasma concentrations during the first 6 days post transplantation compared to the variation of tacrolimus concentrations in stable clinical situation.
- Secondary Outcome Measures
Name Time Method 1. To show that unbound tacrolimus plasma concentrations can better predict the occurrence of renal dysfunction than whole blood total tacrolimus concentrations;<br /><br>2. To study which factors influence unbound tacrolimus plasma concentrations in heart and lung transplant recipients (hematocrit, albumin, α1-acid glycoprotein (AGP), and high density lipoprotein (HDL), pH, extensive volume suppletion or CYP3A4/ CYP3A5 and P-glycoprotein (Pgp) polymorphisms, bowel dysfunction or liver dysfunction);<br /><br>3. To evaluate whether variations in tacrolimus concentrations in the first days after lung transplantation in cystic fibrosis patients are higher than without cystic fibrosis;<br /><br>4. The data will be used to develop a kinetic model in the future in order to be able to adjust the tacrolimus dose to the individual patient to prevent or reduce adverse effects of tacrolimus.