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Brachial Artery Peak Velocity Variation to Predict Fluid Responsiveness

This study has been completed.
Sponsor:
Information provided by:
Hospital del SAS de Jerez
ClinicalTrials.gov Identifier:
NCT00890071
First received: April 28, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Hypotension
Shock
 Other: Fluid administration

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Brachial Artery Peak Velocity Variation to Predict Fluid Responsiveness in Mechanically Ventilated Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital del SAS de Jerez:

Primary Outcome Measures:
  • 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. [ Time Frame: immediately after volume expansion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: immediately after fluid administration ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: immediately after volume expansion ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: December 2008
Study Completion Date: April 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00890071

Locations
Spain
Hospital del SAS de Jerez
Jerez de la Frontera, Cádiz, Spain, 11407
Sponsors and Collaborators
Hospital del SAS de Jerez
Investigators
Principal Investigator: M. Ignacio Monge García Hospital del SAS de Jerez
  More Information

No publications provided by Hospital del SAS de Jerez

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Manuel Ignacio Monge García, Hospital del SAS de Jerez
ClinicalTrials.gov Identifier: NCT00890071     History of Changes
Other Study ID Numbers: UIE-SCCU-200902
Study First Received: April 28, 2009
Last Updated: April 28, 2009
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Hospital del SAS de Jerez:
Fluid responsiveness
Ultrasound
Cardiac output

Additional relevant MeSH terms:
Hypotension
Shock
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013