Observational Study of Blood Pressure Measurements and Continuous Dialysis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2014 by University of Chicago.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
First received: January 27, 2011
Last updated: March 27, 2014
Last verified: March 2014

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.

Kidney Failure
Respiratory Failure
Critical Illness

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Increased doses of vasoactive agents on CRRT [ Time Frame: Iterative 24 hr periods for the duration of CRRT ] [ Designated as safety issue: No ]
  • Inability to meet goal ultrafiltration rate [ Time Frame: Iterative 24 hr periods for the duration of CRRT ] [ Designated as safety issue: No ]
  • Hypotensive events on CRRT [ Time Frame: Iterative 24 hr periods for the duration of CRRT ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: February 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Mechanically ventilated patients
Non-mechanically ventilated patients


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

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01286506

Contact: Michael O'Connor, MD (773) 702-0182 moc5@dacc.uchicago.edu

United States, Illinois
The University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Michael O'Connor, MD    773-702-0182    moc5@dacc.uchicago.edu   
Principal Investigator: Michael O'Connor, MD         
Sponsors and Collaborators
University of Chicago
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 
Study First Received: January 27, 2011
Last Updated: March 27, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on August 25, 2016