NCT00890071

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

April 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 29, 2009

Completed
Last Updated

April 29, 2009

Status Verified

April 1, 2009

Enrollment Period

3 months

First QC Date

April 28, 2009

Last Update Submit

April 28, 2009

Conditions

Keywords

Fluid responsivenessUltrasoundCardiac output

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

Study Arms (1)

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

Interventions

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

Acute circulatory failure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Contraindication for the volume administration: evidence of fluid overload and/or of hydrostatic pulmonary edema
  • Patients with instable cardiac rhythm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital del SAS de Jerez

Jerez de la Frontera, Cádiz, 11407, Spain

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

HypotensionShock

Interventions

Hypodermoclysis

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Infusions, SubcutaneousInfusions, ParenteralDrug Administration RoutesDrug TherapyTherapeuticsFluid Therapy

Study Officials

  • M. Ignacio Monge García

    Hospital del SAS de Jerez

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 28, 2009

First Posted

April 29, 2009

Study Start

December 1, 2008

Primary Completion

March 1, 2009

Study Completion

April 1, 2009

Last Updated

April 29, 2009

Record last verified: 2009-04

Locations