Observational Study of Blood Pressure Measurements and Continuous Dialysis

This study is currently recruiting participants.
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
  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

Resource links provided by NLM:


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)
Groups/Cohorts
Mechanically ventilated patients
Non-mechanically ventilated patients

  Eligibility

Ages Eligible for Study:   18 Years and older
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.

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

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

Locations
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
Investigators
Principal Investigator: Michael O'Connor, MD University of Chicago
Principal Investigator: Jay L Koyner, MD University of Chicago
  More Information

No publications provided

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:
Critical Illness
Renal Insufficiency
Shock
Respiratory Insufficiency
Disease Attributes
Pathologic Processes
Kidney Diseases
Urologic Diseases
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014