NCT00242164

Brief Summary

The study is being performed to better understand dialysis techniques which keep heart functions stable during dialysis. People on dialysis have a high risk for heart disease and strokes. More information about dialysis techniques that keep hearts stable may help prevent the high risk of cardiovascular disease and death and help to reduce discomfort during dialysis. This study will look at the way that the magnesium in dialysate affects heart function during dialysis. High or low levels of magnesium may change the way hearts beat. The question asked is if lowering the amount of magnesium in dialysate will affect the amount of magnesium in blood or change the heart beat.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2005

Completed
13 days until next milestone

Study Start

First participant enrolled

November 1, 2005

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

December 9, 2014

Status Verified

July 1, 2005

Enrollment Period

7 months

First QC Date

October 17, 2005

Last Update Submit

December 8, 2014

Conditions

Chronic Kidney DiseaseArrhythmia

Keywords

HemodialysisMagnesiumArrhythmiaQTc intervalQT dispersion

Outcome Measures

Primary Outcomes (1)

  • The primary outcome is the difference in QT dispersion between low dialysate magnesium and normal dialysate magnesium

    measurement will be the duration of some changes in the EKG.

    over one dialysis session

Interventions

Dialysate Magnesium (Concentration)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age and over with end-stage renal disease. (ESRD)
  • have been on maintenance hemodialysis therapy three times/week for greater than or equal to 3 months
  • All causes of renal failure are included

You may not qualify if:

  • less than 18 years of age
  • have been on maintenance hemodialysis therapy three times/week for less than 3 months
  • are pregnant or lactating
  • unable or unwilling to provide informed consent
  • currently participating in a clinical trial with an intervention
  • systolic (top number) blood pressure levels greater than or equal to 180 or less then 80
  • diastolic (bottom number) blood pressure levels greater than 110
  • a hemoglobin level (red blood cell measure) that is less than 8mg/dl
  • a corrected calcium level that is greater than 11mg/dl or less than 8mg/dl
  • had a change in their anti-hypertensive medications within the last three weeks
  • clinical signs and symptoms of untreated or unresolved infection
  • clinical evidence requiring admission to the hospital
  • had a cerebral vascular accident or myocardial incident within the past 3 months
  • Based on the assessment of the investigators, or study coordinator designee, patients who appear unlikely or unable to participate in the required study procedures
  • Patients with a history of arrhythmias, recent electrophysiological evaluation and or having pacemakers are excluded.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Michigan Dialysis Center

Ann Arbor, Michigan, 48104, United States

Location

University of Michigan Dialysis Center

Livonia, Michigan, 48152, United States

Location

Related Links

MeSH Terms

Conditions

Renal Insufficiency, ChronicArrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular Diseases

Study Officials

  • Panduranga S Rao, MD, DNB, MS

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 17, 2005

First Posted

October 19, 2005

Study Start

November 1, 2005

Primary Completion

June 1, 2006

Study Completion

November 1, 2006

Last Updated

December 9, 2014

Record last verified: 2005-07

Locations

US(2)