Condition category
Haematological Disorders
Date applied
27/06/2016
Date assigned
30/06/2016
Last edited
30/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

Sponsor information

Organisation

CHU-Brugmann

Sponsor details

Place Van Gehuchten 4
Brussels
1020
Belgium

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes