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Completed

NCT Number: NCT04251689

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

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.

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Key information

Conditions

Cis-Platinum Nephropathy Mannitol Adverse Reaction

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Phramongkutklao Hospital

Bangkok, 10400, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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.

Treatment and study plan

Mannitol

Drug

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

Placebo

Drug

0.9% normal saline 100 ml

Primary outcomes

  1. Acute Kidney Injury

    Time frame: 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 outcomes

  1. Decline 24-hour urine creatinine clearance

    Time frame: 48 hours

    Rate of patients with lower than 60 mL/min/1.73m2 of 24-hour urine creatinine clearance after receiving cisplatin

Sponsors and collaborators

Lead sponsor

Phramongkutklao College of Medicine and Hospital

Other

Registry information

Acronym: MACIN

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Feb 5, 2020
Registry last updated
Jan 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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