Condition category
Circulatory System
Date applied
21/07/2015
Date assigned
04/08/2015
Last edited
04/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr B.F. Geerts

ORCID ID

Contact details

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

Additional identifiers

EudraCT 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

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

Trial setting

Hospitals

Trial 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

Phase

Drug names

Primary outcome measures

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 trial start date

01/12/2001

Overall trial end date

01/12/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Patients undergoing elective coronary artery bypass grafting or valve repair

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

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

Trial 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

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

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes