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
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