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Clinical Trials/ISRCTN20479861
ISRCTN20479861
Completed
未知

A prospective randomised controlled trial to evaluate the prevention of sudden cardiac death using Implantable Cardioverter Defibrillators in dialysis patients

eiden University Medical Centre (LUMC) (The Netherlands)0 sites188 target enrollmentMay 2, 2007
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ConditionsImplantable cardiac device (ICD), sudden cardiac death (SCD)Circulatory SystemSudden cardiac death

Overview

Phase
未知
Intervention
Not specified
Conditions
Implantable cardiac device (ICD), sudden cardiac death (SCD)
Sponsor
eiden University Medical Centre (LUMC) (The Netherlands)
Enrollment
188
Status
Completed
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

2008 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/18561878 protocol 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30882234 results (added 04/11/2019) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33606179/ qualitative results (added 22/02/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36016586/ Prevalence of central venous stenosis (added 30/08/2022)

Registry
who.int
Start Date
May 2, 2007
End Date
May 1, 2019
Last Updated
3 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
eiden University Medical Centre (LUMC) (The Netherlands)

Eligibility Criteria

Inclusion Criteria

  • •1\. Patients 55 to 80 years of age
  • •2\. End Stage Renal Disease (ESRD)
  • •3\. Greater than 90 days after start dialysis

Exclusion Criteria

  • •1\. Possible living kidney donation
  • •2\. Terminal congestive heart failure according New York Heart Association (NYHA) class four at time of randomisation
  • •3\. Non\-arrhythmic medical condition making one\-year survival unlikely
  • •4\. Excessive perioperative risk for ICD implantation
  • •5\. Human Immunodeficiency Virus (HIV) infection
  • •6\. Patients with central venous line
  • •7\. Acute Myocardial Infarction (AMI) in the last 40 days
  • •8\. ICD indication according current guidelines
  • •9\. Expected poor compliance with protocol

Outcomes

Primary Outcomes

Not specified

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