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

Primary Purpose

Acute Circulatory Failure

Status
Completed
Phase
Phase 3
Locations
Tunisia
Study Type
Interventional
Intervention
volume expansion using modified gelatin
Sponsored by
University of Monastir
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Circulatory Failure focused on measuring acute circulatory failure, hemodynamic stability, hypovolemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Fattouma Bourguiba
  • Emergency Department FB University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

responder to fluid challenge

Arm Description

fluid challenge

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 21, 2012
Last Updated
May 4, 2016
Sponsor
University of Monastir
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1. Study Identification

Unique Protocol Identification Number
NCT01630577
Brief Title
Central Venous Pressure Change With Volume Challenge in Patients With Hemodynamic Instability
Acronym
CVPCHI
Official Title
Early Change of Central Venous Pressure With Volume Challenge as Predictor of Fluid Responsiveness in Patients With Hemodynamic Instability
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Monastir

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Circulatory Failure
Keywords
acute circulatory failure, hemodynamic stability, hypovolemia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
responder to fluid challenge
Arm Type
Experimental
Arm Description
fluid challenge
Intervention Type
Other
Intervention Name(s)
volume expansion using modified gelatin
Other Intervention Name(s)
fluid challenge
Intervention Description
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.
Primary Outcome Measure Information:
Title
fluid challange responsiveness
Description
change of Stroke volume variation (SVV) by more than 10%
Time Frame
within 20 minutes of fluid challenge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nouira Semir, Professor
Organizational Affiliation
FB University Hospital Monastir Tunisia
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Fattouma Bourguiba
City
Monastir
ZIP/Postal Code
5000
Country
Tunisia
Facility Name
Emergency Department FB University Hospital
City
Monastir
ZIP/Postal Code
5000
Country
Tunisia

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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