Acute changes in metabolic parameters after bolus fluid treatment in critically ill patients
| ISRCTN | ISRCTN31590683 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31590683 |
| Secondary identifying numbers | 1171980 |
- Submission date
- 27/06/2016
- Registration date
- 30/06/2016
- Last edited
- 30/06/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
Plain English summary of protocol
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
Contact information
Scientific
CHU-Brugmann
Place Van Gehuchten 4
Brussels
1020
Belgium
 ORCID ID |
0000-0003-2920-8350 |
|---|---|
| Phone | +32 2477 9126 |
| charalampos.pierrakos@chu-brugmann.be |
Study information
| Study design | Observational cross sectional single-center study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | Metabolic parameters’ changes may be used in the assessment of bolus fluid treatment (BFT) response in clinical practice. |
| Ethics approval(s) | CHU-Brugmann’s Ethical Committee, 14/01/2015, ref: CE2014/122 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/10/2014 |
| Completion date | 30/03/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 15/01/2015 |
| Date of final enrolment | 31/07/2015 |
Locations
Countries of recruitment
- Belgium
Study participating centre
Brussels
1020
Belgium
Sponsor information
Hospital/treatment centre
Place Van Gehuchten 4
Brussels
1020
Belgium
"ROR" |
https://ror.org/011apjk30 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 31/12/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan |
