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

• ClinicalTrials.gov Identifier: NCT01630577
• Recruitment Status: Completed
• First Posted: June 28, 2012
• Last Update Posted: May 5, 2016
• Sponsor: University of Monastir
• Information provided by (Responsible Party): Nouira, University of Monastir

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Acute Circulatory Failure	Other: volume expansion using modified gelatin	Phase 3

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%.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 70 participants
• Allocation: N/A
• 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
• Study Start Date: January 2012
• Actual Primary Completion Date: April 2013
• Actual Study Completion Date: May 2013

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

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
• Other Study ID Numbers: CVPChallenge
• 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