Mölström, Simon http://orcid.org/0000-0002-2778-8075
Nielsen, Troels Halfeld
Nordström, Carl H.
Hassager, Christian
Møller, Jacob Eifer
Kjærgaard, Jesper
Möller, Sören
Schmidt, Henrik
Toft, Palle
Funding for this research was provided by:
Fonden til Lægevidenskabens Fremme (50.000 DKK)
Article History
Received: 11 October 2018
Accepted: 6 May 2019
First Online: 10 June 2019
Ethics approval and consent to participate
: The trial is conducted in accordance with national and international standards for good clinical practice. The local ethics committee has formally approved the protocol and any amendments, including written information and the consent forms prior to initiation of the trial (trial registration: S-20150173 HLP). The protocol is available at ExternalRef removed (ClinicalTrials.gov Identifier: NCT03095742). This trial will be conducted in accordance with national and international standards of good clinical practice. Eligible patients are by inclusion criteria unconscious and unable to give informed consent in the acute setting. Since blood pressure targets may be of importance in neuroprotection via mechanisms thought to reduce reperfusion injuries in the myocardium and in the brain, treatment allocation should be performed as soon as possible. Furthermore, our group has recently reported how it is technically simple and safe to insert a microdialysis catheter in the jugular bulb and monitor biochemical variables related to global cerebral energy metabolism at the bedside during cardiac surgery [CitationRef removed]. Therefore, randomization is performed immediately at admission before informed consent can be obtained according to the Declaration of Helsinki. Patients recovering consciousness will be requested to give informed consent. Legal representatives of the patients (an MD not participating in the study) will be informed and consent will be obtained as quickly as possible. In addition, next of kin will be provided with written and oral information on this trial, allowing them to make an informed decision about participation in this trial. The investigator uses an institutional review board–approved script (Additional file InternalRef removed) that judiciously describes the nature of the intervention, including the use of jugular bulb microdialysis. The consent form must be signed by the participant or legally acceptable surrogate and by the investigator seeking the consent.
: Not applicable.
: The authors declare that they have no competing interests.
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