Brachial Artery Peak Velocity Variation to Predict Fluid Responsiveness

Brachial Artery Peak Velocity Variation to Predict Fluid Responsiveness in Mechanically Ventilated Patients

The investigators designed this study to determine the predictive value for predicting fluid responsiveness of noninvasive evaluation of respiratory variation of peak velocity in brachial artery, in mechanically ventilated patients with acute circulatory failure.

Study Overview

• Status: Completed
• Conditions: Shock; Hypotension
• Intervention / Treatment: Other: Fluid administration

Detailed Description

Predicting the hemodynamic response to fluid administration (or fluid responsiveness) in critical ill patients is still a matter of concern, since fluid overload could worse the clinical situation of these patients. Parameters of fluid responsiveness usually require an invasive monitoring (like arterial pulse pressure variation).

We hypothesize that noninvasive evaluation of respiratory variation of peak velocity in brachial artery using Doppler ultrasound could provide a feasible estimation on fluid responsiveness in mechanically ventilated patients with acute circulatory failure.

• Study Type: Observational
• Enrollment (Actual): 38

Contacts and Locations

Study Locations

• Spain
  • Cádiz
    • Jerez de la Frontera, Cádiz, Spain, 11407
      • Hospital del SAS de Jerez

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

Critical ill patients with controlled mechanical ventilation and acute circulatory failure.

Description

Inclusion Criteria:

• Patients with controlled mechanical ventilation, equipped with an indwelling radial artery catheter and for whom the decision to give fluids will be taken because the presence of one or more clinical signs of acute circulatory failure:

  • systolic blood pressure <90 mmHg (or a decrease >50 mmHg in previously hypertensive patients)
  • the need of vasopressor drugs
  • oliguria (urine output <0.5 ml/kg/min for at least 2 h)
  • tachycardia
  • delayed capillary refilling
  • the presence of skin mottling

Exclusion Criteria:

• Contraindication for the volume administration: evidence of fluid overload and/or of hydrostatic pulmonary edema
• Patients with instable cardiac rhythm

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Acute circulatory failure; Patients for whom the decision to give fluids was taken because the presence of one or more clinical signs of acute circulatory failure.	Other: Fluid administration; 500 ml of synthetic colloid (Voluven®, hydroxyethylstarch 6%; Fresenius, Bad Homburg, Germany) infused over 30 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Predictive value of respiratory variation in brachial artery peak velocity before volume expansion assessed by ROC curve. We defined responser as patients that increased stroke volume index equal or more than 15% after fluid administration.	immediately after volume expansion

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluate the predictive value of pulse pressure variation for predicting hemodynamic response to fluid administration, comparing with the predictive value of respiratory variation of brachial artery peak velocity.	immediately after fluid administration
Evaluate the predictive value of stroke volume variation for predicting hemodynamic response to fluid administration, comparing with the predictive value of respiratory variation of brachial artery peak velocity.	immediately after volume expansion

Collaborators and Investigators

• Sponsor: Hospital del SAS de Jerez
• Investigators: Principal Investigator: M. Ignacio Monge García, Hospital del SAS de Jerez

Publications and helpful links

General Publications

• Monge Garcia MI, Gil Cano A, Diaz Monrove JC. Brachial artery peak velocity variation to predict fluid responsiveness in mechanically ventilated patients. Crit Care. 2009;13(5):R142. doi: 10.1186/cc8027. Epub 2009 Sep 3.

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): April 1, 2009

Study Registration Dates

• First Submitted: April 28, 2009
• First Submitted That Met QC Criteria: April 28, 2009
• First Posted (Estimate): April 29, 2009

Study Record Updates

• Last Update Posted (Estimate): April 29, 2009
• Last Update Submitted That Met QC Criteria: April 28, 2009
• Last Verified: April 1, 2009

More Information

Terms related to this study

• Keywords: Ultrasound; Cardiac output; Fluid responsiveness
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: UIE-SCCU-200902

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No