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Observational Study of Blood Pressure Measurements and Continuous Dialysis

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01286506
First Posted: January 31, 2011
Last Update Posted: August 31, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Chicago
  Purpose

Dialysis is used to control the fluid balance and metabolic state of patients with kidney disease. Control of the metabolic state, via electrolytes, can be monitored using labs that are routinely drawn from patients undergoing continuous hemodialysis. Control of fluid removal is much more difficult. This study aims to determine whether changes in the blood pressure associated with breathing correlate with or predict intolerance to fluid responsiveness with continuous dialysis.

We hypothesize that a measurement of changes in blood pressure with breathing called arterial pulse pressure variation may be able to predict the ability to remove fluid during continuous renal replacement therapy.


Condition
Kidney Failure Respiratory Failure Critical Illness Shock

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study Evaluating the Hemodynamic Relationship Between Volume Removal and Pulse Pressure Variation During Renal Replacement Therapy

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Predictive value of pulse pressure variation for tolerance of fluid removal on CVVHD [ Time Frame: Iterative 24 hr periods for the duration of CRRT ]

Secondary Outcome Measures:
  • Increased doses of vasoactive agents on CRRT [ Time Frame: Iterative 24 hr periods for the duration of CRRT ]
  • Inability to meet goal ultrafiltration rate [ Time Frame: Iterative 24 hr periods for the duration of CRRT ]
  • Hypotensive events on CRRT [ Time Frame: Iterative 24 hr periods for the duration of CRRT ]

Enrollment: 7
Study Start Date: February 2011
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Mechanically ventilated patients
Non-mechanically ventilated patients

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult ICU patients requiring CVVHD who have an indwelling arterial line.
Criteria

Inclusion Criteria:

  • age > 17 years old
  • CVVHD renal replacement therapy
  • indwelling arterial line

Exclusion Criteria:

  • age < 18 years old
  • pregnancy
  • temperature < 34°C
  • severe mechanical ventilator dyssynchrony
  • cardiac arrhythmias precluding automated PPV measurement by ICU monitors
  • non-pulsatile cardiac flow
  • open thoracic cavity
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01286506


Locations
United States, Illinois
The University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Michael O'Connor, MD University of Chicago
Principal Investigator: Jay L Koyner, MD University of Chicago
  More Information

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01286506     History of Changes
Obsolete Identifiers: NCT01153087
Other Study ID Numbers: 16710A
First Submitted: January 27, 2011
First Posted: January 31, 2011
Last Update Posted: August 31, 2016
Last Verified: August 2016

Keywords provided by University of Chicago:
Pulse pressure variation
Continuous venovenous hemodialysis
Volume status
Critical care

Additional relevant MeSH terms:
Respiratory Insufficiency
Critical Illness
Renal Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Kidney Diseases
Urologic Diseases


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