Safety of Short Hydration Method for Cisplatin Administration Compared With Conventional Hydration

Study Overview
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Brief Summary
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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)

Official Title
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Randomized Study Evaluating Safety of Short Hydration Method for Cisplatin Administration Compared With Conventional Hydration

Conditions
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Renal Insufficiency, Cis-Platinum Nephropathy

Intervention / Treatment
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* Procedure: short hydration
* Procedure: conventional hydration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cancer patient who has plan to receive first cycle of cisplatin >= 60 mg/m2 Normal serum creatinine and creatinine clearance >= 50 ml/min Age < 75 years old Serum albumin >= 3 g/dl Plan to receive optimal antiemetic regimen consisting of olanzapine or neurokinase 1 receptor antagonist Exclusion Criteria: The patient who receives other chemotherapy with adminstration volume higher than 500 ml Prior heart failure or known left ventricular ejection fraction > 50% Prior renal dysfunction within 3 months Uncontrolled renal disease current use of diuretic or non-steroidal anti-inflammatory drug (NSAIDs) or starting angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blockade (ARB) within 3 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: short hydration<br>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 | Procedure: short hydration<br>* NSS infusion prior to and following cisplatin administration within 6 hours<br>* Other names: short intravenous fluid infusion;|
| Other: conventional hydration<br>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 | Procedure: conventional hydration<br>* NSS infusion prior to and following cisplatin administration over 24 hours<br>* Other names: long intravenous fluid infusion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | delay or dose reduction or discontinuation of cisplatin due to adverse effect | from starting cisplatin to 4-week after cisplatin discontinuation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cisplatin, renal impairment, hydration protocol