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Central Venous Pressure Change With Volume Challenge in Patients With Hemodynamic Instability (CVPCHI)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01630577
First Posted: June 28, 2012
Last Update Posted: May 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nouira, University of Monastir
  Purpose
We conducted this study to assess the value of early change in central venous pressure (CVP) in predicting fluid responsiveness in mechanically ventilated patients.

Condition Intervention Phase
Acute Circulatory Failure Other: volume expansion using modified gelatin Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Early Change of Central Venous Pressure With Volume Challenge as Predictor of Fluid Responsiveness in Patients With Hemodynamic Instability

Resource links provided by NLM:


Further study details as provided by Nouira, University of Monastir:

Primary Outcome Measures:
  • fluid challange responsiveness [ Time Frame: within 20 minutes of fluid challenge ]
    change of Stroke volume variation (SVV) by more than 10%


Enrollment: 70
Study Start Date: January 2012
Study Completion Date: May 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: responder to fluid challenge
fluid challenge
Other: volume expansion using modified gelatin
Volume expansion using modified gelatin was determined according to a procedure formulated by modifying guidelines produced by Weil and Henning. The maximum volume infusion during the study test was fixed at 400 ml.
Other Name: fluid challenge

Detailed Description:
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. 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 has not been validated in the prediction of fluid responsiveness. We therefore conducted a prospective study that in all patients we measured CVP change and stroke volume variation (SVV) after administration of fluids. Patients were classified as fluid responders when their SVV is >10% after volume expansion and non-responders if SVV is ≤10%.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • mechanically ventilated patients
  • acute circulatory failure defined by the need of vasopressive drugs (dopamine >5µg/kg/per minute or norepinephrine) with signs of tissue hypoperfusion (e.g., altered mental state, mottled skin, urine output below 0.5 ml per kilogram of body weight per hour during at least 2 h).
  • admission serum lactate level more than 2.5mmol/L

Exclusion Criteria:

  • severe hypoxemia defined as a ratio of arterial oxygen pressure to fraction of inspired oxygen [PaO2/FiO2] < 100 mmHg
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01630577


Locations
Tunisia
CHU Fattouma Bourguiba
Monastir, Tunisia, 5000
Emergency Department FB University Hospital
Monastir, Tunisia, 5000
Sponsors and Collaborators
University of Monastir
Investigators
Principal Investigator: Nouira Semir, Professor FB University Hospital Monastir Tunisia
  More Information

Responsible Party: Nouira, professor, University of Monastir
ClinicalTrials.gov Identifier: NCT01630577     History of Changes
Other Study ID Numbers: CVPChallenge
First Submitted: June 21, 2012
First Posted: June 28, 2012
Last Update Posted: May 5, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Nouira, University of Monastir:
acute circulatory failure
hemodynamic stability
hypovolemia

Additional relevant MeSH terms:
Shock
Pathologic Processes