Brachial Artery Peak Velocity Variation to Predict Fluid Responsiveness

Completed

• Conditions: Hypotension; Shock
• Interventions: Other: Fluid administration

• Registration Number: NCT00890071
• Lead Sponsor: Hospital del SAS de Jerez

Brief 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.

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 Timeline

• Study Start: 2008-12
• Primary Completion: 2009-03
• Status Verified: 2009-04
• Study Completion: 2009-04
• Study First Submitted: 2009-04-28
• Study First Submitted QC: 2009-04-28
• Last Update Submitted: 2009-04-28
• Study First Posted: 2009-04-29
• Last Update Posted: 2009-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acute circulatory failure	Fluid administration	Patients for whom the decision to give fluids was taken because the presence of one or more clinical signs of acute circulatory failure.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital del SAS de Jerez; 🇪🇸 Jerez de la Frontera, Cádiz, Spain