NCT04251689

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Phramongkutklao College of Medicine and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cis-Platinum Nephropathy
• Mannitol Adverse Reaction

Interventions

Type	Name	Description
DRUG	Mannitol	Mannitol 20 gram plus 0.9% normal saline 100 ml one hour after cisplatin
DRUG	Placebo	0.9% normal saline 100 ml

Timeline

• Start date: 2018-12-01
• Primary completion: 2020-07-01
• Completion: 2021-02-14
• First posted: 2020-02-05
• Last updated: 2022-01-21

Locations

1 site across 1 country: Thailand