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| Name | Class |
|---|---|
| Siriraj Hospital | OTHER |
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The aim of the study is to evaluate safety of short hydration with cisplatin administration. The main outcome is renal dysfunction following cisplatin use with short hydration protocol. Another group of patients received conventional hydration is the historical control for comparison (Randomized phase II design with a reference standard treatment control arm)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| short hydration | Experimental | Normal saline (NSS) 500 ml infusion in 1 hour cisplatin in NSS 100 ml with 20% mannitol 100 ml infusion in 1 hour other chemotherapy infusion in 1 hour (if available) NSS 500 ml infusion in 1 hour, then NSS 500 ml infusion in 2 hours |
|
| conventional hydration | Other | NSS 1000 ml infusion in 8 hour cisplatin in NSS 100 ml with 20% mannitol 100 ml infusion in 1 hour other chemotherapy infusion in 1 hour (if available) NSS 2000 ml infusion in 16 hour |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| short hydration | Procedure | NSS infusion prior to and following cisplatin administration within 6 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| renal dysfunction at least grade 1 following cisplatin treatment in short hydration group | increased serum creatinine of 0.3 mg/dl or serum creatinine >= 1.5-2x upper normal limit | from starting cisplatin to 4-week after cisplatin discontinuation |
| Measure | Description | Time Frame |
|---|---|---|
| renal dysfunction >= grade 2 following cisplatin treatment in short hydration group | serum creatinine > 2-3x upper normal limit | from starting cisplatin to 4-week after cisplatin discontinuation |
| rate of cisplatin modification due to adverse effects in short hydration group |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Suthinee Ithimakin, MD | Contact | +66898127440 | aesi105@yahoo.co.th |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine Siriraj Hospital | Recruiting | Bangkok | 10260 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39819128 | Derived | Jantarat A, Thamlikitkul L, Thephamongkhol K, Setakornnukul J, Phisalprapa P, Kositamongkol C, Srithongkul T, Ithimakin S. Efficacy and Safety of Short Intravenous Hydration for Preventing Nephrotoxicity From High-Dose Cisplatin: A Randomized, Open-Label, Phase II Trial. JCO Glob Oncol. 2025 Jan;11:e2400515. doi: 10.1200/GO-24-00515. Epub 2025 Jan 16. |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| conventional hydration | Procedure | NSS infusion prior to and following cisplatin administration over 24 hours |
|
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delay or dose reduction or discontinuation of cisplatin due to adverse effect |
| from starting cisplatin to 4-week after cisplatin discontinuation |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |