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

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

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)

Study Overview

• Status: Recruiting
• Conditions: Renal Insufficiency; Cis-Platinum Nephropathy
• Intervention / Treatment: Procedure: short hydration; Procedure: conventional hydration

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Suthinee Ithimakin, MD; Phone Number: +66898127440; Email: aesi105@yahoo.co.th

Study Locations

• Thailand
  • Bangkok, Thailand, 10260
    • Recruiting
    • Faculty of Medicine Siriraj Hospital
    • Contact: Suthinee Ithimakin; Phone Number: 0898127440; Email: aesi105@yahoo.co.th

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Procedure: short hydration; NSS infusion prior to and following cisplatin administration within 6 hours; Other Names: short intravenous fluid infusion
Other: 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	Procedure: conventional hydration; NSS infusion prior to and following cisplatin administration over 24 hours; Other Names: long intravenous fluid infusion

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mahidol University
• Collaborators: Siriraj Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2023
• Primary Completion (Estimated): January 7, 2025
• Study Completion (Estimated): March 7, 2025

Study Registration Dates

• First Submitted: April 30, 2023
• First Submitted That Met QC Criteria: May 23, 2023
• First Posted (Actual): June 1, 2023

Study Record Updates

• Last Update Posted (Actual): June 1, 2023
• Last Update Submitted That Met QC Criteria: May 23, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: cisplatin; renal impairment; hydration protocol
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency
• Other Study ID Numbers: si186/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No