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

NCT04251689 | Completed Phase 2

• 1 other identifier: R023h/62
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Cis-Platinum Nephropathy; Mannitol Adverse Reaction

Outcome Measures

Primary Outcomes (1)

• Acute Kidney Injury

  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

  48 hours

Secondary Outcomes (1)

• Decline 24-hour urine creatinine clearance

  48 hours

Study Arms (2)

intervention

EXPERIMENTAL

mannitol 20 gram plus 0.9% normal saline 100 ml one hour after cisplatin

Drug: Mannitol

placebo

PLACEBO COMPARATOR

0.9% normal saline 100 ml one hour after cisplatin

Drug: Placebo

Interventions

Mannitol DRUG

Mannitol 20 gram plus 0.9% normal saline 100 ml one hour after cisplatin

intervention

Placebo DRUG

0.9% normal saline 100 ml

placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Patients with or had a known allergy to cisplatin or mannitol.
• Patients with chronic heart failure who cannot received fluid more than 1 liter.
• Patients who were not comfortable to follow up at clinic for long term outcome.

Sponsors & Collaborators

• Phramongkutklao College of Medicine and Hospital: lead

Study Sites (1)

Phramongkutklao Hospital

Bangkok, 10400, Thailand

Location

MeSH Terms

Interventions

Mannitol

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2020
• First Posted: February 5, 2020
• Study Start: December 1, 2018
• Primary Completion: July 1, 2020
• Study Completion: February 14, 2021
• Last Updated: January 21, 2022

Record last verified: 2022-01

Locations

TH (1)