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NCT01330004 Clinical Trial

Blood Pressure Change and Outcome

High Blood Pressure Clinical Trial

— BP  

Official title:
The Relationship of Systolic and Diastolic Blood Pressure Changes Over Time to Patient Outcomes in Incident Hemodialysis Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01330004
Other study ID # 080-11
Secondary ID
Status Completed
Phase N/A
First received March 31, 2011
Last updated May 4, 2015
Start date January 1999
Est. completion date December 2010

Study information
Verified date May 2015
Source Renal Research Institute
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 12695
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 88 Years
Eligibility Inclusion Criteria:

- Hemodialysis

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Renal Research Institute New York New York

Sponsors (1)
Lead Sponsor Collaborator
Renal Research Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Effect size of the relation of dynamic changes of blood pressure (BP) at different ranges of BP to survival in incident hemodialysis patients. The ranges of blood pressure measurements in mmHg over time and the relation to patient outcomes (including survival) Up to 11 years and 11 months No
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