Acute Kidney Injury
Conditions
Keywords
Cisplatin nephrotoxicity, Acute kidney injury
Brief summary
The purpose of this study is to determine whether magnesium preloading reduce incident of cisplatin induced acute kidney injury in head and neck cancer who receiving low dose cisplatin (40 mg/m2 weekly for 7 weeks).
Detailed description
Randomized controlled trial comparing efficacy of magnesium preloading versus normal saline for prevention of acute and chronic nephrotoxicity of cisplatin.
Interventions
DRUGMagnesium
Pre loading fluid with Magnesium sulphate 16 milliequivalent plus potassium chloride 20 milliequivalent in Normal saline 500 ml IV drip in 4 hours before Cisplatin administration
OTHERControl
Potassium chloride 20 milliequivalent in Normal saline 500 ml IV drip in 4 hours before Cisplatin administration
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years * Eastern Cooperative Oncology Group score 0-2 * First Diagnosed Head and neck cancer and plan for treatment with cisplatin * Serum creatinine ≤1.5 mg/dl or eGFR≥60(ml/min/1.73 m2)
Exclusion criteria
* Prior treatment with cisplatin before randomization * Uncontrolled concurrent disease * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute kidney injury | 7 days after cisplatin administration | Comparing serum creatinine before Cisplatin treatment and seven days after cisplatin treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nephrotoxicity | up to 12 weeks | Compare serum creatinine before Cisplatin treatment and complete 7 cycles of cisplatin treatment ( up to 12 weeks) |
Countries
Thailand
Outcome results
None listed