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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | 5%DNSS/2 with KCL and MgSO4 IV infusion with rate 125 ml/m2/hr. | |
| Treatment | Experimental | 5%DNSS/2 with KCL and MgSO4 IV infusion with rate 125 ml/m2/hr. plus aminophylline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aminophylline | Drug | Give aminophylline for 5 days to keep serum theophylline level 5-15 mg/dl |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in glomerular filtration rate | Glomerular filtration rate is calculated using Cystatin C-creatinine-based equations. (ref. Kidney Int. 2012 Aug;82(4):445-53.) | Baseline before cisplatin, and 48 hours 72 hours and 21 days post cisplatin |
| Measure | Description | Time Frame |
|---|---|---|
| Renal tubular biomarkers | Urine for beta2 macroglobulin | Baseline before cisplatin, and 48 hours 72 hours and 21 days post cisplatin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anirut Pattaragarn, MD | Contact | 66816651020 | apattaragarn@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Anirut Pattaragarn, MD | Siriraj Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Siriraj hospital, Mahidol university | Bangkok | 10700 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33805488 | Background | McSweeney KR, Gadanec LK, Qaradakhi T, Ali BA, Zulli A, Apostolopoulos V. Mechanisms of Cisplatin-Induced Acute Kidney Injury: Pathological Mechanisms, Pharmacological Interventions, and Genetic Mitigations. Cancers (Basel). 2021 Mar 29;13(7):1572. doi: 10.3390/cancers13071572. | |
| 16038872 | Background | Sugawara M, Mochizuki T, Takekuma Y, Miyazaki K. Structure-affinity relationship in the interactions of human organic anion transporter 1 with caffeine, theophylline, theobromine and their metabolites. Biochim Biophys Acta. 2005 Aug 15;1714(2):85-92. doi: 10.1016/j.bbamem.2005.06.006. |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D000628 | Aminophylline |
| ID | Term |
|---|---|
| D005029 | Ethylenediamines |
| D003959 | Diamines |
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 |
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| 33192231 | Background | Alsaadoun S, Rustom F, Hassan HA, Alkhurais H, Aloufi M, Alzahrani S, Bakhsh S, Dalbhi SA. Aminophylline for improving acute kidney injury in pediatric patients: A systematic review and meta-analysis. Int J Health Sci (Qassim). 2020 Nov-Dec;14(6):44-51. |
| 15590762 | Background | Benoehr P, Krueth P, Bokemeyer C, Grenz A, Osswald H, Hartmann JT. Nephroprotection by theophylline in patients with cisplatin chemotherapy: a randomized, single-blinded, placebo-controlled trial. J Am Soc Nephrol. 2005 Feb;16(2):452-8. doi: 10.1681/ASN.2004030225. Epub 2004 Dec 8. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| Organic Chemicals |
| D013806 | Theophylline |
| D014970 | Xanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |