Plain English Summary
Background and study aims
Seriously ill patients in an intensive care ward often need to have fluid therapy as part of their treatment. This is especially the case for patients who have lost blood or fluids and so do not have enough blood circling around their body (hypovolemia). Hypovolemia is seriously detrimental for patients, as it is accompanied by low cardiac output (volume of blood being pumped by the heart) and insufficient delivery of oxygen to the body's tissues. It is widely acknowledged that IV fluid administration (giving fluids through a drip) should be closely monitored in order to avoid hypovolemia or hypervolemia (fluid overload, often a consequence of treating hypovolemia incorrectly). Assessing changes in cardia output after giving fluids is a reliable method of evaluating patient's response to treatment, however this may not show the long-term consequences. The aim of this study is to investigate the effects of bolus fluid treatment ( of a single, large amount of fluid through a drip) on oxygen delivery to bodily tissues.
Who can participate?
Adults with suspected hypovolemia who are being treated in ICU at CHU-Brugmann (Belgium).
What does the study involve?
For all patients, before they receive the fluid bolus (single delivery of a large amount of fluid), samples of blood from veins and arteries are taken so that the amount of oxygen present canbe measured. The results are then used to calculate the amount of oxygen being delivered to the different tissues in the body and how the tissues are using the oxygen. At the same times, a scan of the heart is performed with a special ultrasound probe to measure cardiac output.
What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with participating in this study.
Where is the study run from?
CHU-Brugmann (Belgium)
When is the study starting and how long is it expected to run for?
October 2014 to March 2016
Who is funding the study?
CHU-Brugmann (Belgium)
Who is the main contact?
Dr Charalampos Pierrakos
Trial website
Contact information
Type
Scientific
Primary contact
Dr Charalampos Pierrakos
ORCID ID
http://orcid.org/0000-0003-2920-8350
Contact details
CHU-Brugmann
Place Van Gehuchten 4
Brussels
1020
Belgium
+32 2477 9126
charalampos.pierrakos@chu-brugmann.be
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1171980
Study information
Scientific title
Evaluating the changes of cardiac output, oxygen and CO2 derived variables and lactate before and after bolus fluid treatment in critically ill patients with suspected hypovolemia
Acronym
Study hypothesis
Metabolic parameters’ changes may be used in the assessment of bolus fluid treatment (BFT) response in clinical practice.
Ethics approval
CHU-Brugmann’s Ethical Committee, 14/01/2015, ref: CE2014/122
Study design
Observational cross sectional single-center study
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Critically ill patients with suspected hypovolemia
Intervention
Patients are included in the study if they needed to receive intravenous fluids consisting of 500 ml of colloids or 1000 ml of crystalloids within 30–50 minutes. The decision to administer bolus fluids is made by the attending physician.
Cardiac index (CI) is measured by using doppler echocardiography or thermodilution (PiCCO®, EV1000®, Swan-Ganz®) just prior to the start of BFT. Arterial and central venous blood sampling and analysis are simultaneously conducted. No interventions are allowed after the start of fluid administration. At the end of fluid administration, the CI measurement and arterial and central venous blood sampling are repeated.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
1. Oxygen consumption (VO2) is calculated using the formula arterial oxygen content-Venous oxygen content before and after bolus fluid treatment
2. Oxygen delivery (DO2) is calculated using the formula 10*CI* arterial oxygen content before and after bolus fluid treatment
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/10/2014
Overall trial end date
30/03/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patient treated in ICU
2. Suspicion of hypovolemia that must be treated
3. Available central venous and arterial catheter
4. Available method for cardiac output measurment (thermodilution, doppler)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. Aged under 18 year
2. No jugular or subclavian venous catheter and arterial catheter
3. Individuals on whom it is not possible to measure cardiac output
4. Patients receiving extracorporeal membrane oxygenation (ECMO) support
5. Receipt of interventions (i.e. introduction or increase in the dose of inotropes, changes or introduction of mechanical ventilation) within 30 minutes prior to fluid administration
Recruitment start date
15/01/2015
Recruitment end date
31/07/2015
Locations
Countries of recruitment
Belgium
Trial participating centre
CHU-Brugmann
Place Van Gehuchten 4
Brussels
1020
Belgium
Funders
Funder type
Hospital/treatment centre
Funder name
CHU-Brugmann
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
Intention to publish date
31/12/2016
Participant level data
Available on request
Basic results (scientific)
Publication list