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Completed

NCT Number: NCT01630577

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

We conducted this study to assess the value of early change in central venous pressure (CVP) in predicting fluid responsiveness in mechanically ventilated patients.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Fattouma Bourguiba, Monastir, Monastir Governorate, Tunisia

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About this study

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%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

volume expansion using modified gelatin

Other

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 names: fluid challenge

Primary outcomes

  1. fluid challange responsiveness

    Time frame: within 20 minutes of fluid challenge

    change of Stroke volume variation (SVV) by more than 10%

Sponsors and collaborators

Lead sponsor

University of Monastir

Other

Registry information

Official study title

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

Acronym: CVPCHI

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 28, 2012
Registry last updated
May 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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