Cis-Platinum Nephropathy, Renal Insufficiency
Conditions
Keywords
renal impairment, cisplatin, hydration protocol
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)
Interventions
PROCEDUREshort hydration
NSS infusion prior to and following cisplatin administration within 6 hours
PROCEDUREconventional hydration
NSS infusion prior to and following cisplatin administration over 24 hours
Sponsors
Siriraj Hospital
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Thailand
Contacts
Primary ContactSuthinee Ithimakin, MD
Outcome results
None listed