Plain English Summary
Background and study aims
Critically ill patients often require fluid therapy to improve circulation. However, only 50% of the patients respond to this fluid therapy. Too much fluid (fluid overload)can be harmful and can contribute to death and disease (morbidity and mortality). To prevent fluid overload in critically ill patients, the mini-fluid challenge can be used. This involves giving each patient a minimal amount of fluid. The patients hemodynamic response to this fluid (for example, the amount of blood being pumped from the heart (cardiac output)and blood pressure)are measured and this response is then used to predict a response to future and further fluid loading. Pulse contour cardiac output methods can predict hoe a patient will respond to being given fluid by providing cardiac output (CO) measurements. The mini-fluid challenge may predict fluid responsiveness with minimum risk of fluid overloading. However, the amount of fluid needed and how best to evaluate the effect of giving it are both unclear. In this study, we therefore studied two pulse contour CO methods in predicting fluid responsiveness using a minimum volume in mini fluid challenges, in critically ill patients.
Who can participate?
Adult patients being mechanical ventilated after heart surgery.
What does the study involve?
Patients are given 10 intravenous doses of 50 mL of fluid (hydroxyethyl starch), resulting in a total of 500 mL being given to each patient. Cardiac output is assessed by various measurements (Modelflow R (FMS, COm) and PulseCOR (LiDCO, COli)) just before each dose and then one minute afterwards.
What are the possible benefits and risks of participating?
There is additional hemodynamic monitoring that gives no additional risks or benefits compared to a standard intensive care treatment.
Where is the study run from?
Leiden University Medical Center, Leiden (The 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 (The Netherlands)
Who is the main contact?
Dr B. F Gerts
Study website
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
P01.111
Study information
Scientific title
Predicting fluid responsiveness using the mini fluid challenge and pulse contour cardiac output measurements : a prospective interventional study
Acronym
Study hypothesis
The hypothesis of the current study is that a more accurate CO measurement technique can lower the amount of fluid that is needed to predict fluid responsiveness by mini challenges. We therefore study two pulse contour CO methods in predicting fluid responsiveness using a minimum volume in mini fluid challenges, in critically ill patients after cardiac surgery.
Ethics approval(s)
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
Study setting(s)
Hospital
Study 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
In each patient, a total of 10 consecutive 50 mL fluid boluses with hydroxyethyl starch solution were administered intravenously. Basic heamodynamic maesurements and cardiac output (CO) were registered, using two different arterial waveform (i.e. pulse contour) methods; modified ModelflowR (COm, FMS, Amsterdam, the Netherlands) and PulseCOR (COli from LiDCO Ltd., London, UK).
Intervention type
Procedure/Surgery
Primary outcome measure
The area under the curve, positive and negative predictive value of COm and COli for the prediction of fluid responsiveness.
Secondary outcome measures
Predictive capabilities of mini fluid challenges from 50 to 500 ml.
Overall study start date
01/12/2001
Overall study end date
01/12/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients undergoing elective coronary artery bypass grafting or valve repair
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
21
Total final enrolment
21
Participant exclusion criteria
1. Previous myocardial infarction
2. Congestive heart failure
3. Aortic aneurysm
4. Extensive peripheral arterial occlusive disease
5. Postoperative valvular insufficiency
6. Artificial pacing and use of a cardiac assist device
Recruitment start date
01/05/2006
Recruitment end date
01/03/2011
Locations
Countries of recruitment
Netherlands, Netherlands Antilles
Study 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
ROR
Funders
Funder type
Hospital/treatment centre
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Stored in repository
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/05/2018 | 12/05/2021 | Yes | No |