Cis-Platinum Nephropathy, Mannitol Adverse Reaction
Conditions
Brief summary
This study include cancer patients who had received chemotherapy that include cisplatin. Patients were randomly assigned to either a mannitol 20 g intravenous single dose after cisplatin or a placebo (saline). The primary outcome was to compare acute kidney injury (AKI), which was defined as increase creatinine 0.3 mg/dl in 48 hours by KDIGO criteria using serum creatinine and 24 hour urine creatinine to calculated.
Interventions
DRUGMannitol
Mannitol 20 gram plus 0.9% normal saline 100 ml one hour after cisplatin
DRUGPlacebo
0.9% normal saline 100 ml
Sponsors
Phramongkutklao College of Medicine and Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Patients who was at least 18 years old. 2. Patients who had been diagnosed with cancer proven by tissue biopsy. 3. Patients who were scheduled to receive cisplatin or combination of cisplatin and other chemotherapy, which the dose of cisplatin was not exceeded 100 mg/m2. 4. Patients were required to have a normal renal function (GFR \> 60 mL/min/1.73m2). 5. Patients with an Eastern Cooperative Oncology Group (ECOG) score ≤ 2. 6. Patients with normal serum sodium and serum potassium level.
Exclusion criteria
1. Patients with any acute kidney injury event before randomized into trial not more than 6 months. 2. Patients with chronic kidney disease or hydronephrosis. 3. Patients with history of nephrectomy. 4. Patients who had previously received immunosuppressants for any immune deficiency disease. 5. Patients with who had received chemotherapy which induce nephrotoxicity. 6. Patients with had received drug which is nephrotoxic (amphotericin B, aminoglycoside or non-steroidal anti-inflammatory drug). 7. Patients who had cirrhosis with child pugh score more than 7. 8. Patients with or had a known allergy to cisplatin or mannitol. 9. Patients with chronic heart failure who cannot received fluid more than 1 liter. 10. Patients who were not comfortable to follow up at clinic for long term outcome.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute Kidney Injury | 48 hours | Rate of patients with serum creatinine increase 0.3 mg/dl or ≥50% or urine output of \<0.5 mL/kg/hour for \>6 hours by AKIN criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Decline 24-hour urine creatinine clearance | 48 hours | Rate of patients with lower than 60 mL/min/1.73m2 of 24-hour urine creatinine clearance after receiving cisplatin |
Countries
Thailand
Outcome results
None listed