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

Not Applicable

Recruiting

• Conditions: Cis-Platinum Nephropathy; Renal Insufficiency
• Interventions: Procedure: short hydration; Procedure: conventional hydration

• Registration Number: NCT05884905
• Lead Sponsor: Mahidol University

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-07
• Study First Submitted: 2023-04-30
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-23
• Last Update Submitted: 2023-05-23
• Study First Posted: 2023-06-01
• Last Update Posted: 2023-06-01
• Primary Completion: 2025-01-07
• Study Completion: 2025-03-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
short hydration	short hydration	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	conventional hydration	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

Primary Outcome Measures

Name	Time	Method
renal dysfunction at least grade 1 following cisplatin treatment in short hydration group	from starting cisplatin to 4-week after cisplatin discontinuation	increased serum creatinine of 0.3 mg/dl or serum creatinine \>= 1.5-2x upper normal limit

Secondary Outcome Measures

Name	Time	Method
rate of cisplatin modification due to adverse effects in short hydration group	from starting cisplatin to 4-week after cisplatin discontinuation	delay or dose reduction or discontinuation of cisplatin due to adverse effect
renal dysfunction >= grade 2 following cisplatin treatment in short hydration group	from starting cisplatin to 4-week after cisplatin discontinuation	serum creatinine \> 2-3x upper normal limit

Trial Locations

Locations (1)

Faculty of Medicine Siriraj Hospital; 🇹🇭 Bangkok, Thailand