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ISRCTN
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ISRCTN07173607
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ClinicalTrials.gov identifier
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Public title
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Do positive end-expiratory pressure-induced changes in cardiac output indicate fluid responsiveness in anaesthetised patients?
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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The magnitude of changes in cardiac output induced by alternating Positive End-Expiratory Pressures (PEEP) predict fluid responsiveness in anaesthetised patients.
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Lay summary
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Ethics approval
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Approved by The Scientific Ethical Committee of North Denmark Region on 13th December 2006.
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Study design
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Interventional, single centre, non-randomised or blinded trial
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Countries of recruitment
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Denmark
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Disease/condition/study domain
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Anaesthetised patients
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Participants - inclusion criteria
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Patients admitted to Aalborg Hospital for elective surgery of the spinal column.
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Participants - exclusion criteria
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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
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Anticipated start date
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08/01/2007
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Anticipated end date
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01/09/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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20
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Interventions
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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.
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Primary outcome measure(s)
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Coherence between the magnitude of the PEEP-induced alterations of SV and the patients fluid responsiveness.
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Secondary outcome measure(s)
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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
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Sources of funding
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Anaesthesia and Intensive Care Medicine of North Denmark Region (Denmark)
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Trial website
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Publications
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Contact name
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Prof
Anders
Larsson
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Address
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Anaesthesia and Intensive Care Medicine of North Denmark Region
Aalborg Hospital
Hobrovej 18-22
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City/town
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Aalborg
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Zip/Postcode
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9000
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Country
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Denmark
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Email
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an.larsson@nja.dk
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Sponsor
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Anaesthesia and Intensive Care Medicine of North Denmark Region (Denmark)
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Address
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Soendre Skovvej 3, 2.
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City/town
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Aalborg
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Zip/Postcode
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9000
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Country
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Denmark
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Tel
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+45 993 28057
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Fax
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+45 993 21122
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Email
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ndn@rn.dk
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Sponsor website:
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http://www.an.rn.dk
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Date applied
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04/01/2007
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Last edited
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14/02/2007
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Date ISRCTN assigned
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14/02/2007
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