Condition category
Circulatory System
Date applied
09/06/2015
Date assigned
24/06/2015
Last edited
22/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

www.lumc.nl

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes