Dias Nummer 1

NONSEDA-trial status November 2014 Thomas Strøm, MD, PhD Helene Korvenius Nedergaard, MD Hanne Tanghus Olsen, MD Palle Toft, Professor, DMsc Department of Intensive Care Odense University Hospital University of Southern Denmark [email protected] I am not dead I am only sleeping 2 Hans Christian Andersen 19th century Danish poet 17-11-2014 Number of ventilator free days in a 28 days period ICU length of stay (28 days) Total hospital length of stay (90 days) Do we need more evidence? Richmond Agitation Sedation Scale (RASS) 0 -1 RASS -5 to +4to -5 RASS -2 -3 1 2 3 4 5 6 7 day No sedation (n=53) Sedation (n=58) Laerkner, Stroem and Toft. In Press. NONSEDA-trial An investigator-initiated, randomised, clinical, parallel- group, multinational, superiority trial Financed by the Danish Strategic Research Council ClinicalTrials.gov Identifier: NCT01967680 Design Randomised, clinical, parallel-group, multinational, superiority trial designed to include 700 patients from at least six ICUs in Denmark, Norway and Sweden. Inclusion criteria • Endotracheally intubated • Expected time on ventilator > 24 hours • Age ≥ 18 years • Informed consent Randomization groups Experimental intervention: Non-sedation supplemented with pain management during mechanical ventilation. Control intervention: Sedation with a daily wake-up trial. Primary Outcome All-cause mortality at 90 days after randomization Secondary outcomes • Proportion of patients with a major cardiovascular event within 90 days after randomisation. • Number of coma and delirium-free days within 28 days from randomisation • Highest Rifle-score within 28 days from randomization • Days until discharge from the intensive care unit within 28 days from randomisation. • Days until the participant is without mechanical ventilation within 28 days from randomisation. Sub-studies Four sub-studies involving 250 patients from the main trial : • Physical function • Cognitive function • Post-Traumatic Stress Disorder (PTSD) • Level of melatonin Site Investigators Denmark, Svendborg:* Hanne Tanghus Olsen, MD, PhD-student. Department of Anaesthesiology and Intensive Care, Svendborg Lone Juhl, RN Hospital, Odense University Hospital Denmark, Kolding:* Helene Korvenius Jorgensen, MD, PhD-student. Department of Anaesthesiology and Intensive Care, Lillebaelt Hospital, Trine Haberlandt, RN Kolding. Denmark, Aarhus:* Helle Nibro, MD, PhD. Department of Anaesthesiology and Intensive Care, Aarhus University Lasse Lundolm, RN Hospital, Aarhus Noerrebrogade. Denmark, Esbjerg:* Jakob Oxlund, MD. Department of Anaesthesiology and Intensive Care, Esbjerg Hospital. Randi Howard, RN Denmark, Odense: Palle Toft, MD, professor, DMSc. Research unit, Department of Anaesthesiology and Intensive Care, Thomas Strøm, MD, PhD, postdoc. Odense University Hospital. Denmark, Copenhagen: Janus Christian Jakobsen, MD, PhD Copenhagen Trial Unit, Centre for Clinical Intervention Research, Jørn Wetterslev, MD, PhD. Rigshospitalet, Copenhagen University Hospital Jane Lindschou, Clinical Research Consultant, MSc. Norway, Tønsberg*: Karl-André Wian, MD Department of Anaesthesiology and Intensive Care, Vestfold Hospital Gro Aagaard, RN Tønsberg Norway, Tromsø* Bjørn Anders Kroken, MD, PhD Department of Anaesthesiology and Intensive Care, Tromsø University Inga Akeren, RN Hospital Sweden, Halmstad*: Michelle Chew, MD, PhD, Associate professor. Department of Anaesthesiology Intensive care, Hallands Hospital Halmstad* Status NON-SEDA November 2014 Patients randomized N Kolding 51 Svendborg 12 Esbjerg 8 Århus 29 Tønsberg 5 Total 105 NON-SEDA status November 2014 700 600 500 400 300 Patients randomized 200 100 0 01jan2014 01jan2015 01jan2016 31dec2016 Date Number included Number projected I am not dead I am only 24 waiting for NON-SEDA 17-11-2014.

Load more