Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06196853
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-09
First Post:
2023-12-25
Brief Title:
Prevention of Cisplatin-induced Nephrotoxicity
Sponsor:
Mahidol University
Organization:
Mahidol University
Study Overview
Official Title:
Nephroprotective Effects of Aminophylline in Pediatric Oncologic Patient on Cisplatin Based Chemotherapy Double Blind Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 5DNSS2 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None