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

Renal Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05884905
• Other study ID #: si186/2023
• Status: Recruiting
• Phase: N/A
• Start date: March 7, 2023
• Est. completion date: March 7, 2025

Study information

• Verified date: May 2023
• Source: Mahidol University
• Contact: Suthinee Ithimakin, MD
• Phone: +66898127440
• Email: aesi105[@]yahoo.co.th
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 7, 2025
• Est. primary completion date: January 7, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cis-Platinum Nephropathy
• Renal Insufficiency

Intervention

Procedure:
• short hydration
NSS infusion prior to and following cisplatin administration within 6 hours
• conventional hydration
NSS infusion prior to and following cisplatin administration over 24 hours

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Mahidol University	Siriraj Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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