Condition category
Surgery
Date applied
04/01/2007
Date assigned
14/02/2007
Last edited
14/02/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Anders Larsson

ORCID ID

Contact details

Anaesthesia and Intensive Care Medicine of North Denmark Region
Aalborg Hospital
Hobrovej 18-22
Aalborg
9000
Denmark
an.larsson@nja.dk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

The magnitude of changes in cardiac output induced by alternating Positive End-Expiratory Pressures (PEEP) predict fluid responsiveness in anaesthetised patients.

Ethics approval

Approved by The Scientific Ethical Committee of North Denmark Region on 13th December 2006.

Study design

Interventional, single centre, non-randomised or blinded trial

Primary study design

Interventional

Secondary study design

Single-centre

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Condition

Anaesthetised patients

Intervention

While monitoring cardiac Stroke Volume (SV) we alternate the Positive End-Expiratory Pressure (PEEP) by 10 cm H2O. If the PEEP-alteration results in a change in SV of more than 5 mL we hypothesise that the patient is fluid responsive.

Subsequently we measure SV before and after loading the patient with 250 mL of Hydroxyethyl Starch (Voluven®) to obtain a measure of the patients fluid responsiveness.

Intervention type

Drug

Phase

Not Specified

Drug names

Hydroxyethyl Starch (Voluven®)

Primary outcome measures

Coherence between the magnitude of the PEEP-induced alterations of SV and the patients fluid responsiveness.

Secondary outcome measures

1. Coherence between the magnitude of PEEP-induced alterations of pulse pressure and the patients fluid responsiveness
2. Coherence between the magnitude of PEEP-induced alterations of heart rate and the patients fluid responsiveness

Overall trial start date

08/01/2007

Overall trial end date

01/09/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Patients admitted to Aalborg Hospital for elective surgery of the spinal column.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. Severe right-sided cardiac insufficiency
2. Severe anaemia
3. Pregnancy
4. Children (age less than 18 years)
5. Patients without esophageal doppler monitoring of cardiac output
6. Patients who experience severe complications during anaesthesia

Recruitment start date

08/01/2007

Recruitment end date

01/09/2007

Locations

Countries of recruitment

Denmark

Trial participating centre

Anaesthesia and Intensive Care Medicine of North Denmark Region
Aalborg
9000
Denmark

Sponsor information

Organisation

Anaesthesia and Intensive Care Medicine of North Denmark Region (Denmark)

Sponsor details

Soendre Skovvej 3
2.
Aalborg
9000
Denmark
+45 993 28057
ndn@rn.dk

Sponsor type

Hospital/treatment centre

Website

http://www.an.rn.dk

Funders

Funder type

Hospital/treatment centre

Funder name

Anaesthesia and Intensive Care Medicine of North Denmark Region (Denmark)

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