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Blood Pressure Change and Outcome (BP)

This study has been completed.
Sponsor:
Information provided by:
Renal Research Institute
ClinicalTrials.gov Identifier:
NCT01330004
First received: March 31, 2011
Last updated: May 18, 2011
Last verified: May 2011
History of Changes
  Purpose

Hyper- and hypotension are important predictors of survival in non-ESRD (end stage renal disease) population. In dialysis patients, however, it has been shown that higher blood pressure levels may actually be beneficial to patient outcomes. Dynamics of blood pressure evolution over time has not been previously studied in dialysis population. The investigators aim to understand how both blood pressure levels and blood pressure changes over time predict patient survival.


Condition
Renal Disease
High Blood Pressure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Relationship of Systolic and Diastolic Blood Pressure Changes Over Time to Patient Outcomes in Incident Hemodialysis Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Renal Research Institute:

Primary Outcome Measures:
  • Effect size of the relation of dynamic changes of blood pressure (BP) at different ranges of BP to survival in incident hemodialysis patients. [ Time Frame: Up to 11 years and 11 months ] [ Designated as safety issue: No ]
    The ranges of blood pressure measurements in mmHg over time and the relation to patient outcomes (including survival)


Enrollment: 12695
Study Start Date: January 1999
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Hemodialysis patients

  Eligibility

Ages Eligible for Study:   18 Years to 88 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Renal Research Institute hemodialysis patients

Criteria

Inclusion Criteria:

  • Hemodialysis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01330004

Locations
United States, New York
Renal Research Institute
New York, New York, United States, 10128
Sponsors and Collaborators
Renal Research Institute
Investigators
Principal Investigator: Nathan W Levin, MD Renal Research Institute
  More Information

No publications provided by Renal Research Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Nathan Levin MD, Renal Research Institute
ClinicalTrials.gov Identifier: NCT01330004     History of Changes
Other Study ID Numbers: 080-11
Study First Received: March 31, 2011
Last Updated: May 18, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypertension
Kidney Diseases
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on June 18, 2013