Clinical trial NCT00890071: Brachial Artery Peak Velocity Variation to Predict Fluid Responsiveness
Official title: Brachial Artery Peak Velocity Variation to Predict Fluid Responsiveness in Mechanically Ventilated Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypotension
Shock
Keywords: Fluid responsiveness
Ultrasound
Cardiac output
Lead sponsor: Hospital del SAS de Jerez
Sponsor class: OTHER
First posted: 2009-04-29
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critical ill patients with controlled mechanical ventilation and acute circulatory failure.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: immediately after volume expansion
Secondary outcomes:
measure: 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.
timeFrame: immediately after fluid administration
measure: 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.
timeFrame: immediately after volume expansion
Other outcomes:
Locations:
city: Jerez de la Frontera
country: Spain
facility: Hospital del SAS de Jerez
state: Cádiz
Study officials:
affiliation: Hospital del SAS de Jerez
name: M. Ignacio Monge García
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.