Central Venous Pressure Trial Challenge
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Purpose
In patients with shock a primary goal of treatment is to restore and maintain organ perfusion, for which an adequate cardiac preload is required. Apart from the situations in which hypovolemia is evident and a favourable response to fluid administration will be seen, clinical and biological parameters often fail to predict hypovolemia. Inappropriate use of volume expansion carries out the risk of generating volume overload and pulmonary oedema and/or right-ventricular dysfunction. Consequently, reliable predictors of fluid responsiveness are needed especially in the early phase of cardiocirculatory deterioration. In the clinical setting, different static and dynamic indices have been shown to be useful indicators of cardiac preload. Central venous pressure (CVP) is widely used to measure right ventricular preload in patients requiring invasive hemodynamic monitoring. However, the use of the CVP is much criticized because CVP poorly predicts cardiac preload and volume status. However several decades ago, Weil and Henning proposed the fluid challenge technique, based on the 2-5 rule using CVP. There is a method for guiding volume repletion based on measurements of the patient's response to fluid load. This method had never validated in the prediction of fluid responsiveness. We therefore conducted a prospective study to assess whether the 2-5 rule using CVP could predict fluid responsiveness in mechanically ventilated patients with acute circulatory failure.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Circulatory Failure |
Other: volume of serum salin titated to CVP level |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Value of Central Venous Pressure Trial Challenge in Predicting Fluid Responsiveness in Critically Ill Patients |
- fluid dependency [ Time Frame: within one hour of fluid challenge ] [ Designated as safety issue: Yes ]change of cardiac output by more than 10%
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: responder to fluid challenge
fluid challenge
|
Other: volume of serum salin titated to CVP level
volume of serum salin titated to CVP level
Other Name: fluid challenge
|
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- acute circulatory failure defined by a systolic blood pressure < 90 mmHg or the need of vasopressive drugs (dopamine> 5µg/kg/min or norepinephrine);
- instrumentation with indwelling pulmonary artery catheters;
- hemodynamic stability, defined by a variation in heart rate, blood pressure, and cardiac output (CO) of less than 10% over the 15-min before starting the protocol.
Exclusion Criteria:
- Patients were excluded if they have severe hypoxemia (ratio of arterial oxygen pressure to fraction of inspired oxygen [PaO2/FiO2] < 100 mmHg, or a PVC ≥ 12 mmHg.
Contacts and Locations| Contact: Nouira Semir, Professor | 216 73 532 014 | semir.nouira@rns.tn |
| Tunisia | |
| Emergency Department FB University Hospital | Recruiting |
| Monastir, Tunisia, 5000 | |
| Contact: Marghli Soudani, Professor 216 98 408 159 soudani.marghli@rns.tn | |
| Principal Investigator: | Nouira Semir, Professor | FB University Hospital Monastir Tunisia |
More Information
No publications provided
| Responsible Party: | Nouira, professor, University of Monastir |
| ClinicalTrials.gov Identifier: | NCT01630577 History of Changes |
| Other Study ID Numbers: | CVPChallenge |
| Study First Received: | June 21, 2012 |
| Last Updated: | June 26, 2012 |
| Health Authority: | Tunisia: Ministry of Public Health |
Keywords provided by University of Monastir:
|
acute circulatory failure hemodynamic stability hypovolemia |
Additional relevant MeSH terms:
|
Shock Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013