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Comparing vancomycin dose adjustment based on two equations for estimation of kidney function in liver transplant recipients

Comparison of two equations for estimation of kidney function (Cockcroft-Gault versus GRAIL) for vancomycin dosing to achieve the desired serum level of the drug in liver transplant recipients with renal insufficiency

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20100111003043N14
Enrollment
30
Registered
2019-09-24
Start date
2019-11-21
Completion date
Unknown
Last updated
2019-11-05

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

Conditions

Condition 1: liver transplantation patients. Condition 2: cirrhotic patients. Liver transplant failure and rejection Fibrosis and cirrhosis of liver

Interventions

Intervention 1: Intervention group: First intervention group: Initial dose of Vancomycin is determined according to the renal function estimation by GRAIL (Glomerular filtration Rate Assessment In Liv

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Adults recipients of liver transplant who are more than 18 years old and they are admitted in liver transpalnt ward and receiving Vancomycin antibiotic. The plasma creatinine should be in a steady level for at least 48 to 72 hours (variation of less than 0.3mg/dL is acceptable). The estimated rate of kidney function of included patients should be less than 90mL/min according to Cockcroft-Gault equation. Patients should sign the informed consent.

Exclusion criteria

Exclusion criteria: Patients who take medications (such as Cefazolin, Cimetidine, high dose of vitamin C, Methyldopa) which they interact with creatinine level measurement should be excluded from the study except patients taking Cotrimoxazole. Each patient should take the PCP prophylaxis dose of Cotrimoxazole. Patients who are candidate for receiving therapeutic dose of Cotrimoxazole are not excluded from the study and their kidney function is evaluated before administration of Cotrimoxazole. Patients who receive liver and kidney transplant simultaneously. Retransplant patients. Patients who require dialysis due to acute or chronic renal failure. Pregnant and lactating women. Patients who receive Albumin (up to 2 days after receiving Albumin).

Design outcomes

Primary

MeasureTime frame
Trough Vancomycin blood level (trough concentration of fourth and fifth dose). Timepoint: Blood level of Vancomycin within 30 minutes before administration of next dose of the drug. Method of measurement: laboratory specimen by means of fluorescence polarization immunoassay.;Peak Vancomycin blood level (peak of the fourth dose). Timepoint: 1.5 to 2.5 hours after a one hour infusion or one hour after a 2 hours infusion due to completion of distribution phase. Method of measurement: laboratory specimen by means of fluorescence polarization immunoassay.;Area under the time-concentration cure of Vancomycin. Timepoint: It is calculated for fourth dose of the dug. Method of measurement: It will be calculated by pharmacokinetic formula.

Secondary

MeasureTime frame
Evaluation of length of hospital stay. Timepoint: Daily from the start of Vancomycin administration until the time of discharge from the hospital. Method of measurement: Counting the days of hospital stay.;Evaluation of duration of antibiotic therapy. Timepoint: Daily from the start of antibiotic treatment until the end of antibiotic therapy duration. Method of measurement: Counting the days that patient receives antibiotic.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactYasaman Saee

Tehran University of Medical Sciences

yasamansaee@yahoo.com+98 21 6695 4709

Outcome results

None listed

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