Brachial Artery Peak Velocity Variation to Predict Fluid Responsiveness

Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00890071
• Other study ID #: UIE-SCCU-200902
• Status: Completed
• Phase: N/A
• First received: April 28, 2009
• Last updated: April 28, 2009
• Start date: December 2008
• Est. completion date: April 2009

Study information

• Verified date: April 2009
• Source: Hospital del SAS de Jerez
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: April 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypotension
• Shock

Intervention

Other:
• Fluid administration
500 ml of synthetic colloid (Voluven®, hydroxyethylstarch 6%; Fresenius, Bad Homburg, Germany) infused over 30 minutes

Locations

Country	Name	City	State
Spain	Hospital del SAS de Jerez	Jerez de la Frontera	Cádiz

Sponsors (1)

Lead Sponsor	Collaborator
Hospital del SAS de Jerez

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No