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

• Sponsor: Phramongkutklao College of Medicine and Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04251689
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arms: 2
• Actual Duration (Months): 26.5
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cis-Platinum Nephropathy; Mannitol Adverse Reaction	Drug: Mannitol; Drug: Placebo	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: The Effect of Intravenous Mannitol Plus Saline on the Prevention of Cisplatin-induced Nephrotoxicity: A Randomized, Double-blind, Placebo Controlled Trial
• Actual Study Start Date: Dec 1, 2018
• Actual Primary Completion Date: Jul 1, 2020
• Actual Study Completion Date: Feb 14, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: intervention mannitol 20 gram plus 0.9% normal saline 100 ml one hour after cisplatin	Drug: Mannitol; Mannitol 20 gram plus 0.9% normal saline 100 ml one hour after cisplatin
Placebo Comparator: placebo 0.9% normal saline 100 ml one hour after cisplatin	Drug: Placebo; 0.9% normal saline 100 ml

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Phramongkutklao Hospital	Bangkok		Thailand	10400

Sponsors and Collaborators

• Phramongkutklao College of Medicine and Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Phramongkutklao College of Medicine and Hospital
• ClinicalTrials.gov Identifier: NCT04251689
• Other Study ID Numbers: R023h/62
• First Posted: Feb 5, 2020
• Last Update Posted: Jan 21, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Kidney Diseases; Mannitol

Study Results

No Results Posted as of Jan 21, 2022