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

NCT ID: NCT04251689

Last Updated: 2022-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2021-02-14

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

intervention

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

Group Type: EXPERIMENTAL

Mannitol

Intervention Type: DRUG

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

placebo

0.9% normal saline 100 ml one hour after cisplatin

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

0.9% normal saline 100 ml

Interventions

Mannitol

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

Intervention Type: DRUG

Placebo

0.9% normal saline 100 ml

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Phramongkutklao College of Medicine and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Phramongkutklao Hospital

Bangkok, , Thailand

Countries

Thailand

Other Identifiers

R023h/62

Identifier Type: -

Identifier Source: org_study_id