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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
NSS infusion prior to and following cisplatin administration within 6 hours
NSS infusion prior to and following cisplatin administration over 24 hours
Faculty of Medicine Siriraj Hospital
Bangkok, Thailand
RECRUITINGrenal 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
Time frame: from starting cisplatin to 4-week after cisplatin discontinuation
renal dysfunction >= grade 2 following cisplatin treatment in short hydration group
serum creatinine \> 2-3x upper normal limit
Time frame: 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
Time frame: from starting cisplatin to 4-week after cisplatin discontinuation
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