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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

Tracking Information
First Submitted Date  ICMJE May 17, 2015
First Posted Date  ICMJE June 25, 2015
Last Update Posted Date August 20, 2019
Actual Study Start Date  ICMJE March 2015
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2015)
Acute kidney injury [ Time Frame: 7 days after cisplatin administration ]
Comparing serum creatinine before Cisplatin treatment and seven days after cisplatin treatment
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02481518 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2015)
Nephrotoxicity [ Time Frame: up to 12 weeks ]
Compare serum creatinine before Cisplatin treatment and complete 7 cycles of cisplatin treatment ( up to 12 weeks)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preloading Magnesium Attenuate Cisplatin-induced Nephrotoxicity
Official Title  ICMJE Preloading Magnesium Attenuate Cisplatin-induced Nephrotoxicity
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).
Detailed Description Randomized controlled trial comparing efficacy of magnesium preloading versus normal saline for prevention of acute and chronic nephrotoxicity of cisplatin.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Acute Kidney Injury
Intervention  ICMJE
  • 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
  • Other: Control
    Potassium chloride 20 milliequivalent in Normal saline 500 ml IV drip in 4 hours before Cisplatin administration
    Other Name: Normal saline
Study Arms  ICMJE
  • Experimental: Magnesium
    Magnesium preloading group : Magnesium preloading for Cisplatin treatment
    Intervention: Drug: Magnesium
  • Active Comparator: Control
    Control group : Normal saline preloading for cisplatin treatment
    Intervention: Other: Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 18, 2019)
30
Original Estimated Enrollment  ICMJE
 (submitted: June 24, 2015)
100
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02481518
Other Study ID Numbers  ICMJE 2558/172
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mahidol University
Study Sponsor  ICMJE Mahidol University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Arkom Nongnuch, MD Ramathibodi hospital, Mahidol university
PRS Account Mahidol University
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP