Observational Study of Blood Pressure Measurements and Continuous Dialysis

Critical Illness Clinical Trial

Official title:

Observational Study Evaluating the Hemodynamic Relationship Between Volume Removal and Pulse Pressure Variation During Renal Replacement Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01286506
• Other study ID #: 16710A
• Status: Terminated
• Phase: N/A
• First received: January 27, 2011
• Last updated: August 29, 2016
• Start date: February 2011
• Est. completion date: December 2015

Study information

• Verified date: August 2016
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

Other known NCT identifiers

• NCT01153087

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Critical Illness
• Kidney Failure
• Renal Insufficiency
• Respiratory Failure
• Respiratory Insufficiency
• Shock

Locations

Country	Name	City	State
United States	The University of Chicago Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predictive value of pulse pressure variation for tolerance of fluid removal on CVVHD		Iterative 24 hr periods for the duration of CRRT	No
Secondary	Increased doses of vasoactive agents on CRRT		Iterative 24 hr periods for the duration of CRRT	No
Secondary	Inability to meet goal ultrafiltration rate		Iterative 24 hr periods for the duration of CRRT	No
Secondary	Hypotensive events on CRRT		Iterative 24 hr periods for the duration of CRRT	No