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Brachial Artery Peak Velocity Variation to Predict Fluid Responsiveness

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ClinicalTrials.gov Identifier: NCT00890071
Recruitment Status : Completed
First Posted : April 29, 2009
Last Update Posted : April 29, 2009
Sponsor:
Information provided by:
Hospital del SAS de Jerez

Tracking Information
First Submitted Date April 28, 2009
First Posted Date April 29, 2009
Last Update Posted Date April 29, 2009
Study Start Date December 2008
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 28, 2009)
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 ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: April 28, 2009)
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Brachial Artery Peak Velocity Variation to Predict Fluid Responsiveness
Official Title Brachial Artery Peak Velocity Variation to Predict Fluid Responsiveness in Mechanically Ventilated Patients
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Critical ill patients with controlled mechanical ventilation and acute circulatory failure.
Condition
  • Hypotension
  • Shock
Intervention Other: Fluid administration
500 ml of synthetic colloid (Voluven®, hydroxyethylstarch 6%; Fresenius, Bad Homburg, Germany) infused over 30 minutes
Study Groups/Cohorts 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.
Intervention: Other: Fluid administration
Publications * Monge García MI, Gil Cano A, Díaz Monrové 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 28, 2009)
38
Original Actual Enrollment Same as current
Actual Study Completion Date April 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT00890071
Other Study ID Numbers UIE-SCCU-200902
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Manuel Ignacio Monge García, Hospital del SAS de Jerez
Study Sponsor Hospital del SAS de Jerez
Collaborators Not Provided
Investigators
Principal Investigator: M. Ignacio Monge García Hospital del SAS de Jerez
PRS Account Hospital del SAS de Jerez
Verification Date April 2009