Condition category
Surgery
Date applied
26/07/2012
Date assigned
16/08/2012
Last edited
09/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Background and study aims
Patients undergoing surgery often require fluids to be infused into their veins to compensate for blood loss. However, giving patients fluids is only beneficial if it increases the volume of blood pumped by the heart, but this ‘fluid responsiveness’ varies depending on the patient’s blood volume. This is mostly assessed using invasive techniques, so current practice does not include this assessment in most patients under anesthetic. The Nexfin monitor uses a non-invasive finger cuff to assess blood parameters and can be used in all patients under general anesthetic. The aim of this study is to assess the value of using the Nexfin monitor to predict the fluid responsiveness of patients under anesthetic.

Who can participate?
Patients aged over 18 undergoing surgery under general anesthetic.

What does the study involve?
During normal routine clinical practice, we record the patients’ hemodynamic parameters (e.g., blood pressure, volume of blood pumped by the heart, heart rate) using the Nexfin monitor during procedures where fluid administration was required. We evaluate the changes in these parameters during fluid administration and their value in predicting the patients’ fluid responsiveness.

What are the possible benefits and risks of participating?
There are no benefits or risks involved.

Where is the study run from?
University Medical Center Groningen (Netherlands).

When is the study starting and how long is it expected to run for?
November 2011 to August 2012.

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Alain Kalmar

Trial website

Contact information

Type

Scientific

Primary contact

Dr Alain Kalmar

ORCID ID

Contact details

University Medical Center Groningen
Hanzeplein 1
Groningen
9700 RB
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

vol-001

Study information

Scientific title

Value of Nexfin SVV and PPV to predict fluid responsiveness during anaesthesia

Acronym

Study hypothesis

The dynamic preload variables (SSV and PPV) assessed by Nexfin, are better predictors to assess fluid responsiveness than blood pressure or heart rate

Ethics approval

Medisch Ethische Toetsingscommissie (METc), Universitair Medisch Centrum Groningen, 19/04/012, ref: metc2012/107

Study design

Retrospective data analysis

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Anaesthesia

Intervention

N/A

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

We will evaluate the evolution of hemodynamic parameters during the period of fluid administration and the value of the dynamic preload-variables to predict fluid responsiveness

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/11/2011

Overall trial end date

08/08/2012

Reason abandoned

Objectives no longer viable

Eligibility

Participant inclusion criteria

>18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

Participant exclusion criteria

Unable or unwilling to grant written informed consent for data analysis

Recruitment start date

01/11/2011

Recruitment end date

08/08/2012

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Center Groningen
Groningen
9700 RB
Netherlands

Sponsor information

Organisation

University Medical Center Groningen (Netherlands)

Sponsor details

Hanzeplein 1
PO Box 30001
Groningen
9700 RB
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.umcg.nl/

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

Please note that this trial was stopped as of 28/11/2012.