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

Phase 2

Completed

• Conditions: Cis-Platinum Nephropathy; Mannitol Adverse Reaction
• Interventions: Drug: Placebo; Drug: Mannitol

• Registration Number: NCT04251689
• Lead Sponsor: Phramongkutklao College of Medicine and Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-01
• Study First Submitted: 2020-01-30
• Study First Submitted QC: 2020-01-30
• Study First Posted: 2020-02-05
• Primary Completion: 2020-07-01
• Study Completion: 2021-02-14
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-19
• Last Update Posted: 2022-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	0.9% normal saline 100 ml one hour after cisplatin
intervention	Mannitol	mannitol 20 gram plus 0.9% normal saline 100 ml one hour after cisplatin

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Phramongkutklao Hospital; 🇹🇭 Bangkok, Thailand