Predicting fluid responsiveness using the mini fluid challenge and pulse contour cardiac output measurements

ISRCTN	ISRCTN37554354
DOI	https://doi.org/10.1186/ISRCTN37554354
Secondary identifying numbers	P01.111

Submission date: 21/07/2015
Registration date: 04/08/2015
Last edited: 12/05/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr B.F. Geerts
Scientific

Department of Anesthesiology
Amsterdam Medical Center
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Study information

Study design	Prospective interventional study
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Predicting fluid responsiveness using the mini fluid challenge and pulse contour cardiac output measurements : a prospective interventional study
Study objectives	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
Health condition(s) or problem(s) studied	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
Completion date	01/12/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	21
Total final enrolment	21
Key inclusion criteria	Patients undergoing elective coronary artery bypass grafting or valve repair
Key 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
Date of first enrolment	01/05/2006
Date of final enrolment	01/03/2011

Locations

Countries of recruitment

Netherlands
Netherlands Antilles

Study participating centre

Leiden University Medical Center

Albinusdreef 2
Leiden
2333ZA
Netherlands

Sponsor information

Department of Intensive Care Medicine, Leiden University Medical Center
University/education

Albinusdreef 2
Leiden
2333ZA
Netherlands

"ROR"	https://ror.org/05xvt9f17

Funders

Funder type

Hospital/treatment centre

Department of Intensive Care Medicine, Leiden University Medical Center

No information available

Results and Publications

Intention to publish date	01/01/2015
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Stored in repository
Publication and dissemination plan	We plan to publish the results in a peer reviewed journal
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/05/2018	12/05/2021	Yes	No

Editorial Notes

12/05/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.