Do positive end-expiratory pressure-induced changes in cardiac output indicate fluid responsiveness in anaesthetised patients?
ISRCTN | ISRCTN07173607 |
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DOI | https://doi.org/10.1186/ISRCTN07173607 |
Secondary identifying numbers | N/A |
- Submission date
- 04/01/2007
- Registration date
- 14/02/2007
- Last edited
- 14/02/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Anders Larsson
Scientific
Scientific
Anaesthesia and Intensive Care Medicine of North Denmark Region
Aalborg Hospital
Hobrovej 18-22
Aalborg
9000
Denmark
an.larsson@nja.dk |
Study information
Study design | Interventional, single centre, non-randomised or blinded trial |
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Primary study design | Interventional |
Secondary study design | Single-centre |
Study setting(s) | Hospital |
Study type | Other |
Scientific title | |
Study objectives | The magnitude of changes in cardiac output induced by alternating Positive End-Expiratory Pressures (PEEP) predict fluid responsiveness in anaesthetised patients. |
Ethics approval(s) | Approved by The Scientific Ethical Committee of North Denmark Region on 13th December 2006. |
Health condition(s) or problem(s) studied | 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 |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Hydroxyethyl Starch (Voluven®) |
Primary outcome measure | 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 study start date | 08/01/2007 |
Completion date | 01/09/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 20 |
Key inclusion criteria | Patients admitted to Aalborg Hospital for elective surgery of the spinal column. |
Key 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 |
Date of first enrolment | 08/01/2007 |
Date of final enrolment | 01/09/2007 |
Locations
Countries of recruitment
- Denmark
Study participating centre
Anaesthesia and Intensive Care Medicine of North Denmark Region
Aalborg
9000
Denmark
9000
Denmark
Sponsor information
Anaesthesia and Intensive Care Medicine of North Denmark Region (Denmark)
Hospital/treatment centre
Hospital/treatment centre
Soendre Skovvej 3, 2.
Aalborg
9000
Denmark
Phone | +45 993 28057 |
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ndn@rn.dk | |
Website | http://www.an.rn.dk |
https://ror.org/003gkfx86 |
Funders
Funder type
Hospital/treatment centre
Anaesthesia and Intensive Care Medicine of North Denmark Region (Denmark)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |