Blood Pressure Change and Outcome (BP)

May 4, 2015 updated by: Renal Research Institute

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

12695

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10128
        • Renal Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Renal Research Institute hemodialysis patients

Description

Inclusion Criteria:

  • Hemodialysis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Hemodialysis patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Renal Research Institute

Investigators

  • Principal Investigator: Nathan W Levin, MD, Renal Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1999

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

March 31, 2011

First Submitted That Met QC Criteria

April 5, 2011

First Posted (Estimate)

April 6, 2011

Study Record Updates

Last Update Posted (Estimate)

May 5, 2015

Last Update Submitted That Met QC Criteria

May 4, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 080-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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