The Effect of Intravenous Mannitol Plus Saline on the Prevention of Cisplatin-induced Nephrotoxic… (NCT04251689) | Clinical Trial Compass
CompletedPhase 2/3
The Effect of Intravenous Mannitol Plus Saline on the Prevention of Cisplatin-induced Nephrotoxicity: A Randomized, Double-blind, Placebo Controlled Trial
Thailand48 participantsStarted 2018-12-01
Plain-language 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.
Who can participate
Age range18 Years – 90 Years
SexALL
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Inclusion criteria
✓. Patients who was at least 18 years old.
✓. Patients who had been diagnosed with cancer proven by tissue biopsy.
✓. 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.
✓. Patients were required to have a normal renal function (GFR \> 60 mL/min/1.73m2).
✓. Patients with an Eastern Cooperative Oncology Group (ECOG) score ≤ 2.
✓. Patients with normal serum sodium and serum potassium level.
Exclusion criteria
✕. Patients with any acute kidney injury event before randomized into trial not more than 6 months.
✕. Patients with chronic kidney disease or hydronephrosis.
✕. Patients with history of nephrectomy.
✕. Patients who had previously received immunosuppressants for any immune deficiency disease.
✕. Patients with who had received chemotherapy which induce nephrotoxicity.
✕. Patients with had received drug which is nephrotoxic (amphotericin B, aminoglycoside or non-steroidal anti-inflammatory drug).
✕. Patients who had cirrhosis with child pugh score more than 7.
What they're measuring
1
Acute Kidney Injury
Timeframe: 48 hours
Trial details
NCT IDNCT04251689
SponsorPhramongkutklao College of Medicine and Hospital