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Completed

NCT Number: NCT02481518

Preloading Magnesium Attenuate Cisplatin-induced Nephrotoxicity

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).

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of medicine, Ramathibodi Hospital, Mahidol University

Bangkok, 10400, Thailand

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnesium

Drug

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

Control

Other

Potassium chloride 20 milliequivalent in Normal saline 500 ml IV drip in 4 hours before Cisplatin administration

Other names: Normal saline

Primary outcomes

  1. Acute kidney injury

    Time frame: 7 days after cisplatin administration

    Comparing serum creatinine before Cisplatin treatment and seven days after cisplatin treatment

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Acronym: PRAGMATIC

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 25, 2015
Registry last updated
Aug 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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