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Preloading Magnesium Attenuate Cisplatin-induced Nephrotoxicity (PRAGMATIC)

Primary Purpose

Acute Kidney Injury

Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Magnesium
Control
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Kidney Injury focused on measuring Cisplatin nephrotoxicity, Acute kidney injury

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of medicine, Ramathibodi Hospital, Mahidol University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Magnesium

Control

Arm Description

Magnesium preloading group : Magnesium preloading for Cisplatin treatment

Control group : Normal saline preloading for cisplatin treatment

Outcomes

Primary Outcome Measures

Acute kidney injury
Comparing serum creatinine before Cisplatin treatment and seven days after cisplatin treatment

Secondary Outcome Measures

Nephrotoxicity
Compare serum creatinine before Cisplatin treatment and complete 7 cycles of cisplatin treatment ( up to 12 weeks)

Full Information

First Posted
May 17, 2015
Last Updated
August 18, 2019
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT02481518
Brief Title
Preloading Magnesium Attenuate Cisplatin-induced Nephrotoxicity
Acronym
PRAGMATIC
Official Title
Preloading Magnesium Attenuate Cisplatin-induced Nephrotoxicity
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
Keywords
Cisplatin nephrotoxicity, Acute kidney injury

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Magnesium
Arm Type
Experimental
Arm Description
Magnesium preloading group : Magnesium preloading for Cisplatin treatment
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Control group : Normal saline preloading for cisplatin treatment
Intervention Type
Drug
Intervention Name(s)
Magnesium
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Control
Other Intervention Name(s)
Normal saline
Intervention Description
Potassium chloride 20 milliequivalent in Normal saline 500 ml IV drip in 4 hours before Cisplatin administration
Primary Outcome Measure Information:
Title
Acute kidney injury
Description
Comparing serum creatinine before Cisplatin treatment and seven days after cisplatin treatment
Time Frame
7 days after cisplatin administration
Secondary Outcome Measure Information:
Title
Nephrotoxicity
Description
Compare serum creatinine before Cisplatin treatment and complete 7 cycles of cisplatin treatment ( up to 12 weeks)
Time Frame
up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arkom Nongnuch, MD
Organizational Affiliation
Ramathibodi hospital, Mahidol university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of medicine, Ramathibodi Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand

12. IPD Sharing Statement

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Preloading Magnesium Attenuate Cisplatin-induced Nephrotoxicity

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