drugset / Trial / NCT04251689

The Effect of Intravenous Mannitol Plus Saline on the Prevention of Cisplatin-induced Nephrotoxicity: A Randomized, Double-blind, Placebo Controlled Trial

NCT04251689

Phase 2/3 Completed 48 enrolled Phramongkutklao College of Medicine and Hospital
RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start
2018-12-01
Primary completion
2020-07-01
Completion
2021-02-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Mannitol Diagnostic / imaging agent 20 g Intravenous

Indications