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

Sponsor

Mahidol University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05884905

Collaborator

Siriraj Hospital (Other)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Renal Insufficiency Cis-Platinum Nephropathy	Procedure: short hydration Procedure: conventional hydration	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 7, 2023

Anticipated Primary Completion Date :

Jan 7, 2025

Anticipated Study Completion Date :

Mar 7, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine Siriraj Hospital	Bangkok		Thailand	10260

Sponsors and Collaborators

Mahidol University
Siriraj Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mahidol University

ClinicalTrials.gov Identifier:

NCT05884905

Other Study ID Numbers:

si186/2023

First Posted:

Jun 1, 2023

Last Update Posted:

Jun 1, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mahidol University

renal impairment

cisplatin

hydration protocol

Additional relevant MeSH terms:

Renal Insufficiency

Study Results

No Results Posted as of Jun 1, 2023