search
Back to results

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

Primary Purpose

Cis-Platinum Nephropathy, Mannitol Adverse Reaction

Status
Completed
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
Mannitol
Placebo
Sponsored by
Phramongkutklao College of Medicine and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cis-Platinum Nephropathy

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Phramongkutklao Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

intervention

placebo

Arm Description

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

0.9% normal saline 100 ml one hour after cisplatin

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 30, 2020
Last Updated
January 19, 2022
Sponsor
Phramongkutklao College of Medicine and Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04251689
Brief Title
The Effect of Intravenous Mannitol Plus Saline on the Prevention of Cisplatin-induced Nephrotoxicity: A Randomized, Double-blind, Placebo Controlled Trial
Acronym
MACIN
Official Title
The Effect of Intravenous Mannitol Plus Saline on the Prevention of Cisplatin-induced Nephrotoxicity: A Randomized, Double-blind, Placebo Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
February 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Phramongkutklao College of Medicine and Hospital

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cis-Platinum Nephropathy, Mannitol Adverse Reaction

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention
Arm Type
Experimental
Arm Description
mannitol 20 gram plus 0.9% normal saline 100 ml one hour after cisplatin
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
0.9% normal saline 100 ml one hour after cisplatin
Intervention Type
Drug
Intervention Name(s)
Mannitol
Intervention Description
Mannitol 20 gram plus 0.9% normal saline 100 ml one hour after cisplatin
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
0.9% normal saline 100 ml
Primary Outcome Measure Information:
Title
Acute Kidney Injury
Description
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
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Decline 24-hour urine creatinine clearance
Description
Rate of patients with lower than 60 mL/min/1.73m2 of 24-hour urine creatinine clearance after receiving cisplatin
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Phramongkutklao Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs