Central Venous Pressure Trial Challenge

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Monastir.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Nouira, University of Monastir
ClinicalTrials.gov Identifier:
NCT01630577
First received: June 21, 2012
Last updated: June 26, 2012
Last verified: June 2012
  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

Resource links provided by NLM:


Further study details as provided by University of Monastir:

Primary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01630577

Contacts
Contact: Nouira Semir, Professor 216 73 532 014 semir.nouira@rns.tn

Locations
Tunisia
Emergency Department FB University Hospital Recruiting
Monastir, Tunisia, 5000
Contact: Marghli Soudani, Professor    216 98 408 159    soudani.marghli@rns.tn   
Sponsors and Collaborators
University of Monastir
Investigators
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 August 01, 2014