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

Cis-Platinum Nephropathy Clinical Trial

— MACIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04251689
• Other study ID #: R023h/62
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: December 1, 2018
• Est. completion date: February 14, 2021

Study information

• Verified date: January 2022
• Source: Phramongkutklao College of Medicine and Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 14, 2021
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cis-Platinum Nephropathy
• Kidney Diseases
• Mannitol Adverse Reaction

Intervention

Drug:
• Mannitol
Mannitol 20 gram plus 0.9% normal saline 100 ml one hour after cisplatin
• Placebo
0.9% normal saline 100 ml

Locations

Country	Name	City	State
Thailand	Phramongkutklao Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Phramongkutklao College of Medicine and Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Decline 24-hour urine creatinine clearance	Rate of patients with lower than 60 mL/min/1.73m2 of 24-hour urine creatinine clearance after receiving cisplatin	48 hours