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Observational Study of Blood Pressure Measurements and Continuous Dialysis

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Chicago
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01286506
First received: January 27, 2011
Last updated: March 27, 2014
Last verified: March 2014

January 27, 2011
March 27, 2014
February 2011
June 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01286506 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Observational Study of Blood Pressure Measurements and Continuous Dialysis
Observational Study Evaluating the Hemodynamic Relationship Between Volume Removal and Pulse Pressure Variation During Renal Replacement Therapy

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Adult ICU patients requiring CVVHD who have an indwelling arterial line.

  • Kidney Failure
  • Respiratory Failure
  • Critical Illness
  • Shock
Not Provided
  • Mechanically ventilated patients
  • Non-mechanically ventilated patients
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
June 2015
June 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Michael O'Connor, MD (773) 702-0182 moc5@dacc.uchicago.edu
United States
 
NCT01286506
16710A
No
University of Chicago
University of Chicago
Not Provided
Principal Investigator: Michael O'Connor, MD University of Chicago
Principal Investigator: Jay L Koyner, MD University of Chicago
University of Chicago
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP