Acute Kidney Injury, Renal Tubulopathy
Conditions
Keywords
Acute Kidney Injury, Chemotherapy induced kidney related complication
Brief summary
The research design is a prospective, randomized, controlled clinical trial in children to study effect of aminophylline in preserving renal function in oncologic patient received cisplatin either combined with other CMT or used alone. The participants in both groups will receive standard protocol pre-cisplatin infusion which include hydration with 5%DNSS/2 with KCL and MgSO4 IV infusion. In the treatment group, the participants will receive aminophylline infusion in the first 24 hours along with cisplatin, followed by oral aminophylline oral three times daily orally for 4 consecutive days post cisplatin. The aminophylline serum level will be maintained at the therapeutic range 10-20 mg. The side effect of aminophylline including nausea, vomiting and ECG will be monitored. The collected data including urine volume, GFR (estimated by cystatin C-creatinine based equation and by radiopharmaceutical-Tc DTPA), and renal tubular biomarker (urine B2 macroglobulin and urine NGAL) will be collected at baseline before receiving cisplatin, 24 hours and 5 days post cisplatin.
Interventions
DRUGAminophylline
Give aminophylline for 5 days to keep serum theophylline level 5-15 mg/dl
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* Age under 18 years old * Oncology patients who receive cisplatin-based therapy
Exclusion criteria
* Preexisting renal anomalies * Preexisting GFR less than 60 ml/min/1.73 m2 * Contraindication of aminophylline including structural heart disease, arrhythmia, hyperthyroidism, chronic liver disease, epilepsy * Aminophylline use within 24 hours prior to study entry
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in glomerular filtration rate | Baseline before cisplatin, and 48 hours 72 hours and 21 days post cisplatin | Glomerular filtration rate is calculated using Cystatin C-creatinine-based equations. (ref. Kidney Int. 2012 Aug;82(4):445-53.) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Renal tubular biomarkers | Baseline before cisplatin, and 48 hours 72 hours and 21 days post cisplatin | Urine for beta2 macroglobulin |
Countries
Thailand
Contacts
Primary ContactAnirut Pattaragarn, MD
Outcome results
None listed