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

Acute Circulatory Failure Clinical Trial

— CVPCHI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01630577
• Other study ID #: CVPChallenge
• Status: Completed
• Phase: Phase 3
• First received: June 21, 2012
• Last updated: May 4, 2016
• Start date: January 2012
• Est. completion date: May 2013

Study information

• Verified date: May 2016
• Source: University of Monastir
• Contact: n/a
• Is FDA regulated: No
• Health authority: Tunisia: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Acute Circulatory Failure
• Shock

Intervention

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.

Locations

Country	Name	City	State
Tunisia	CHU Fattouma Bourguiba	Monastir
Tunisia	Emergency Department FB University Hospital	Monastir

Sponsors (1)

Lead Sponsor	Collaborator
University of Monastir

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fluid challange responsiveness	change of Stroke volume variation (SVV) by more than 10%	within 20 minutes of fluid challenge	Yes