Clinical trial NCT01630577: Central Venous Pressure Change With Volume Challenge in Patients With Hemodynamic Instability
Official title: Early Change of Central Venous Pressure With Volume Challenge as Predictor of Fluid Responsiveness in Patients With Hemodynamic Instability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Circulatory Failure
Keywords: acute circulatory failure
hemodynamic stability
hypovolemia
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2012-06-28
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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 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

Primary outcomes:
measure: fluid challange responsiveness
timeFrame: within 20 minutes of fluid challenge
Secondary outcomes:
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: CHU Fattouma Bourguiba
city: Monastir
country: Tunisia
facility: Emergency Department FB University Hospital
Study officials:
affiliation: FB University Hospital Monastir Tunisia
name: Nouira Semir, Professor
role: PRINCIPAL_INVESTIGATOR
References: