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Preloading Magnesium Attenuate Cisplatin-induced Nephrotoxicity (PRAGMATIC)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02481518
Recruitment Status : Completed
First Posted : June 25, 2015
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Mahidol University

Brief Summary:
The purpose of this study is to determine whether magnesium preloading reduce incident of cisplatin induced acute kidney injury in head and neck cancer who receiving low dose cisplatin (40 mg/m2 weekly for 7 weeks).

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Drug: Magnesium Other: Control Phase 4

Detailed Description:
Randomized controlled trial comparing efficacy of magnesium preloading versus normal saline for prevention of acute and chronic nephrotoxicity of cisplatin.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preloading Magnesium Attenuate Cisplatin-induced Nephrotoxicity
Actual Study Start Date : March 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Magnesium
Magnesium preloading group : Magnesium preloading for Cisplatin treatment
Drug: Magnesium
Pre loading fluid with Magnesium sulphate 16 milliequivalent plus potassium chloride 20 milliequivalent in Normal saline 500 ml IV drip in 4 hours before Cisplatin administration

Active Comparator: Control
Control group : Normal saline preloading for cisplatin treatment
Other: Control
Potassium chloride 20 milliequivalent in Normal saline 500 ml IV drip in 4 hours before Cisplatin administration
Other Name: Normal saline




Primary Outcome Measures :
  1. Acute kidney injury [ Time Frame: 7 days after cisplatin administration ]
    Comparing serum creatinine before Cisplatin treatment and seven days after cisplatin treatment


Secondary Outcome Measures :
  1. Nephrotoxicity [ Time Frame: up to 12 weeks ]
    Compare serum creatinine before Cisplatin treatment and complete 7 cycles of cisplatin treatment ( up to 12 weeks)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Eastern Cooperative Oncology Group score 0-2
  • First Diagnosed Head and neck cancer and plan for treatment with cisplatin
  • Serum creatinine ≤1.5 mg/dl or eGFR≥60(ml/min/1.73 m2)

Exclusion Criteria:

  • Prior treatment with cisplatin before randomization
  • Uncontrolled concurrent disease
  • Pregnancy

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): NCT02481518


Locations
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Thailand
Faculty of medicine, Ramathibodi Hospital, Mahidol University
Bangkok, Thailand, 10400
Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Arkom Nongnuch, MD Ramathibodi hospital, Mahidol university

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Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT02481518    
Other Study ID Numbers: 2558/172
First Posted: June 25, 2015    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Keywords provided by Mahidol University:
Cisplatin nephrotoxicity
Acute kidney injury
Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Cisplatin
Antineoplastic Agents