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.

Study Overview

• Status: Terminated
• Conditions: Shock; Critical Illness; Respiratory Failure; Kidney Failure

• Study Type: Observational
• Enrollment (Actual): 7

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • The University of Chicago Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Mechanically ventilated patients
Non-mechanically ventilated patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Predictive value of pulse pressure variation for tolerance of fluid removal on CVVHD	Iterative 24 hr periods for the duration of CRRT

Secondary Outcome Measures

Outcome Measure	Time Frame
Increased doses of vasoactive agents on CRRT	Iterative 24 hr periods for the duration of CRRT
Inability to meet goal ultrafiltration rate	Iterative 24 hr periods for the duration of CRRT
Hypotensive events on CRRT	Iterative 24 hr periods for the duration of CRRT

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Michael O'Connor, MD, University of Chicago

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: January 27, 2011
• First Submitted That Met QC Criteria: January 27, 2011
• First Posted (Estimate): January 31, 2011

Study Record Updates

• Last Update Posted (Estimate): August 31, 2016
• Last Update Submitted That Met QC Criteria: August 29, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Critical care; Pulse pressure variation; Continuous venovenous hemodialysis; Volume status
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Kidney Diseases; Urologic Diseases; Disease Attributes; Respiratory Insufficiency; Renal Insufficiency; Critical Illness
• Other Study ID Numbers: 16710A