Clinical Trials Directory

Trials / Completed

CompletedNCT01630577

Central Venous Pressure Change With Volume Challenge in Patients With Hemodynamic Instability

Early Change of Central Venous Pressure With Volume Challenge as Predictor of Fluid Responsiveness in Patients With Hemodynamic Instability

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
70 (actual)
Sponsor
University of Monastir · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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%.

Conditions

Interventions

TypeNameDescription
OTHERvolume expansion using modified gelatinVolume 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.

Timeline

Start date
2012-01-01
Primary completion
2013-04-01
Completion
2013-05-01
First posted
2012-06-28
Last updated
2016-05-05

Locations

2 sites across 1 country: Tunisia

Source: ClinicalTrials.gov record NCT01630577. Inclusion in this directory is not an endorsement.