HypotensionNCT00890071
Brachial Artery Peak Velocity Variation to Predict Fluid Responsiveness
An observational study of Hypotension and Shock, run by Hospital del SAS de Jerez at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypotension, Shock
- What is being tested?
- Fluid administration
- How many people
- 38 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2008to Apr 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critical ill patients with controlled mechanical ventilation and acute circulatory failure.
Who may be able to join
- 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
Who cannot join
- Contraindication for the volume administration: evidence of fluid overload and/or of hydrostatic pulmonary edema
- Patients with instable cardiac rhythm
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brachial Artery Peak Velocity Variation to Predict Fluid Responsiveness in Mechanically Ventilated Patients
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.
Read the 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.
- Conditions
- Hypotension, Shock
- Being tested
- Fluid administration
- Keywords
- Fluid responsiveness, Ultrasound, Cardiac output
- Medical subject headings
- Hypotension, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid administrationOther
500 ml of synthetic colloid (Voluven®, hydroxyethylstarch 6%; Fresenius, Bad Homburg, Germany) infused over 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Fluid administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: immediately after volume expansion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2009 (estimated)
- Study startDec 2008
- Primary completionMar 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital del SAS de Jerez
- Sponsor type
- University, hospital or other
- Investigators
- M. Ignacio Monge García, Principal investigator, Hospital del SAS de Jerez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00890071
- Sponsor's protocol ID
- UIE-SCCU-200902
- Status last verified
- Apr 2009
- First submitted
- 28 Apr 2009
- Last updated
- 29 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19728876
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brachial Artery Peak Velocity Variation to Predict Fluid Responsiveness in Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT00890071
- Acronym / sponsor ID
- UIE-SCCU-200902
- Conditions
- Hypotension, Shock
- Keywords
- Fluid responsiveness, Ultrasound, Cardiac output
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Hospital del SAS de JerezUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 29 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute circulatory failure | – | Other: Fluid administrationPatients for whom the decision to give fluids was taken because the presence of one or more clinical signs of acute circulatory failure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critical ill patients with controlled mechanical ventilation and acute circulatory failure.
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (2 listed)
- Contraindication for the volume administration: evidence of fluid overload and/or of hydrostatic pulmonary edema
- Patients with instable cardiac rhythm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluid administration500 ml of synthetic colloid (Voluven®, hydroxyethylstarch 6%; Fresenius, Bad Homburg, Germany) infused over 30 minutes | Other | Acute circulatory failure |
Primary outcome
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
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2009.
- Derived from this study: PubMed 19728876Monge 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M. Ignacio Monge García principal investigator
Hospital del SAS de Jerez
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypotension and Shock, run by Hospital del SAS de Jerez at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: immediately after volume expansion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00890071, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2009.