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

Mahidol University

Status: Enrolling

Conditions: Cis-Platinum Nephropathy; Renal Insufficiency

Treatments: Procedure: short hydration; Procedure: conventional hydration

Study type: Interventional

Funder types: Other

Identifiers

NCT05884905

si186/2023

Details and patient eligibility

About

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)

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

short hydration

Experimental group

Description:

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

Treatment:

Procedure: short hydration

conventional hydration

Other group

Description:

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

Treatment:

Procedure: conventional hydration