Preloading Magnesium Attenuate Cisplatin-induced Nephrotoxicity

Acute Kidney Injury Clinical Trial

— PRAGMATIC  

Official title:

Preloading Magnesium Attenuate Cisplatin-induced Nephrotoxicity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02481518
• Other study ID #: 2558/172
• Status: Completed
• Phase: Phase 4
• Start date: March 2015
• Est. completion date: March 2016

Study information

• Verified date: August 2019
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

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

Locations

Country	Name	City	State
Thailand	Faculty of medicine, Ramathibodi Hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute kidney injury	Comparing serum creatinine before Cisplatin treatment and seven days after cisplatin treatment	7 days after cisplatin administration
Secondary	Nephrotoxicity	Compare serum creatinine before Cisplatin treatment and complete 7 cycles of cisplatin treatment ( up to 12 weeks)	up to 12 weeks