Plain English Summary
Background and study aims
Fluids are frequently given to patients who have undergone cardiac surgery to improve their circulation. However, only 50% of patients respond to fluid administration and it is not easily to predict which patient will be a "fluid-responder". To make matters worse, giving too little or too much fluid can have harmful effects. The variation in the arterial blood pressure caused by mechanical ventilation has shown to help in the prediction of "fluid-responsiveness". More simply put; if the arterial blood pressure shows a marked change during inspiration (breathing in) and expiration (breathing out), this could indicate a relative underfilling of the circulation (i.e. less fluid in the circulation) and the patient is more likely to respond to fluid administration, where if the arterial blood pressure would remain unaltered this would likely not be the case. However, a good functioning arterial catheter is necessary to detect these changes. We want to find out if changes in the "venous blood pressure" induced by mechanical ventilation is also a good predictor of "fluid-responsiveness", which requires a central venous catheter.
Who can participate?
Cardiac surgery patients treated in intensive care and mechanically ventilated.
What does the study involve?
Patients who have undergone cardiac surgery are standard equipped with an arterial and central venous catheter and therefore we can investigate in this patient group if the venous blood pressure variations can predict the response upon a fluid administration of 500cc compared to the arterial blood pressure variation. If so, then physicians have another tool to guide patient-tailored fluid administration. Besides from the administration of 500cc of fluids, no additional interventions are performed in this study other than standard care after surgery.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Leiden University Medical Center (Netherlands)
When is the study starting and how long is it expected to run for?
December 2001 to December 2014
Who is funding the study?
Department of Intensive Care Medicine, Leiden University Medical Center (Netherlands)
Who is the main contact?
Dr Thomas Cherpanath
Trial website
Contact information
Type
Scientific
Primary contact
Dr Thomas Cherpanath
ORCID ID
http://orcid.org/0000-0003-3845-1950
Contact details
Meibergdreef 9
Amsterdam
1105AZ
Netherlands
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
P01.111
Study information
Scientific title
Central venous pressure variation: a prospective interventional study
Acronym
Study hypothesis
Ventilator-induced central venous pressure variation is able to predict fluid responsiveness
Ethics approval
Medical Ethics Committee, Leiden University Medical Center, Leiden, the Netherlands, 28/01/2002, ref: P01.111
Study design
Prospective interventional study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Postoperative mechanically ventilated cardiac surgery patients
Intervention
Stroke volume variation and pulse pressure variation were measured with pulse contour analysis using an arterial catheter, while central venous pressure variation was obtained from a central venous catheter.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Correlation, sensitivity and specificity of central venous pressure variation in the prediction of fluid responsiveness.
Secondary outcome measures
Accuracy of central venous pressure variation in comparison to stroke volume variation and pulse pressure variation.
Overall trial start date
01/12/2001
Overall trial end date
01/12/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Elective cardiac surgery patients postoperatively on the Intensive Care Unit who are mechanically ventilated with tidal volumes of 8-10 mL/kg without spontaneous breathing efforts or cardiac arrhythmia.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
20
Participant exclusion criteria
1. Previous myocardial infarction
2. Congestive heart failure
3. Extensive peripheral arterial occlusive disease
4. Severe arrhythmia
5. Use of a cardiac assist device
6. Artificial pacing, postoperative valvular insufficiency or presence of spontaneous breathing during mechanical ventilation
Recruitment start date
01/05/2006
Recruitment end date
01/03/2011
Locations
Countries of recruitment
Netherlands
Trial participating centre
Leiden University Medical Center
Albinusdreef 2
Leiden
2333ZA
Netherlands
Sponsor information
Organisation
Department of Intensive Care Medicine, Leiden University Medical Center
Sponsor details
Albinusdreef 2
Leiden
2333ZA
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
Not defined
Funder name
Department of Intensive Care Medicine, Leiden University Medical Center
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
We plan to publish the results in a peer reviewed journal
Intention to publish date
01/01/2015
Participant level data
Stored in repository
Basic results (scientific)
Publication list