ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ISRCTN
Last refreshed on:	24 May 2021
Main ID:	ISRCTN37554354
Date of registration:	04/08/2015
Prospective Registration:	No
Primary sponsor:	Department of Intensive Care Medicine, Leiden University Medical Center
Public title:	Predicting fluid responsiveness using the mini fluid challenge and pulse contour cardiac output measurements
Scientific title:	Predicting fluid responsiveness using the mini fluid challenge and pulse contour cardiac output measurements : a prospective interventional study
Date of first enrolment:	01/05/2006
Target sample size:	21
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN37554354
Study type:	Interventional
Study design:	Prospective interventional study (Diagnostic)
Phase:	Not Applicable

Countries of recruitment
Netherlands	Netherlands Antilles

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:	B.F. Geerts
Address:	Department of Anesthesiology Amsterdam Medical Center Meibergdreef 9 1105 AZ Amsterdam Netherlands
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria: Patients undergoing elective coronary artery bypass grafting or valve repair
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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Postoperative mechanically ventilated cardiac surgery patients
Circulatory System

Intervention(s)

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).

Primary Outcome(s)

The area under the curve, positive and negative predictive value of COm and COli for the prediction of fluid responsiveness.

Secondary Outcome(s)

Predictive capabilities of mini fluid challenges from 50 to 500 ml.

Secondary ID(s)

P01.111

Source(s) of Monetary Support

Department of Intensive Care Medicine, Leiden University Medical Center

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

Medical Ethics Committee, Leiden University Medical Center, Leiden, the Netherlands, 28/01/2002, ref: P01.111

Results

Results available:	Yes
Date Posted:
Date Completed:	01/12/2014
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.