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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04251689
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : August 18, 2020
Sponsor:
Information provided by (Responsible Party):
Phramongkutklao College of Medicine and Hospital

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 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
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : February 14, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Creatinine

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04251689


Contacts
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Contact: Panot Sainamthip +66955974249 panotonco@outlook.com

Locations
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Thailand
Phramongkutklao Hospital Recruiting
Bangkok, Thailand, 10400
Contact: Suthee Panichkul    6623547600 ext 93681    suthee99@yahoo.com   
Sponsors and Collaborators
Phramongkutklao College of Medicine and Hospital
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Responsible Party: Phramongkutklao College of Medicine and Hospital
ClinicalTrials.gov Identifier: NCT04251689    
Other Study ID Numbers: R023h/62
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: August 18, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Kidney Diseases
Urologic Diseases
Mannitol
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs