Central venous pressure variation
| ISRCTN | ISRCTN60025937 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN60025937 |
| Secondary identifying numbers | P01.111 |
- Submission date
- 09/06/2015
- Registration date
- 24/06/2015
- Last edited
- 10/05/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Scientific
Meibergdreef 9
Amsterdam
1105AZ
Netherlands
 ORCID ID |
0000-0003-3845-1950 |
|---|
Study information
| Study design | Prospective interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Central venous pressure variation: a prospective interventional study |
| Study objectives | Ventilator-induced central venous pressure variation is able to predict fluid responsiveness |
| Ethics approval(s) | Medical Ethics Committee, Leiden University Medical Center, Leiden, the Netherlands, 28/01/2002, ref: P01.111 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/12/2001 |
| Completion date | 01/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 20 |
| Total final enrolment | 19 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/05/2006 |
| Date of final enrolment | 01/03/2011 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leiden
2333ZA
Netherlands
Sponsor information
University/education
Albinusdreef 2
Leiden
2333ZA
Netherlands
| Website | www.lumc.nl |
|---|---|
"ROR" |
https://ror.org/05xvt9f17 |
Funders
Funder type
Not defined
No information available
Results and Publications
| Intention to publish date | 01/01/2015 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | We plan to publish the results in a peer reviewed journal |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/11/2016 | 10/05/2021 | Yes | No |
Editorial Notes
10/05/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
