Project Details
Projekt
Sedation Practice in Intensive Care Evaluation: Early Sedation with dexmedetomidine in Older Ventilated Critically Ill Patients (SPICE-IV) - Randomized Double Blind Placebo Controlled Trial
Applicant
Professor Dr. Alexander Zarbock
Subject Area
Anaesthesiology
Term
since 2024
Project identifier
Deutsche Forschungsgemeinschaft (DFG) - Project number 534710408
Dexmedetomidine is a substance classified as an alpha-2 agonist and primarily utilized for the purpose of conscious sedation and the treatment of agitation. It acts as a highly selective agonist at the alpha-2 receptor in the locus coeruleus, a nucleus located in the pons region of the brainstem. By this mechanism, dexmedetomidine effectively induces sedation while preserving the ability of patients treated with this substance to be easily awakened. This aligns with current, evidence based approaches of sedation management in intensive care medicine. These emphasize maintaining patients wakeful and attentive while ensuring them to be free from pain, anxiety, and can tolerate medical interventions, such as controlled ventilation. Dexmedetomidine received approval in Germany in 2011 and has been subject to several studies. A large-scale, nonrandomized study (SPICE III) conducted in Australia has demonstrated the association between the early use of dexmedetomidine as a sedative agent and improved survival outcomes, particularly in older patients (above 65 years) within the perioperative setting. A subsequent planned secondary analysis has confirmed these findings, revealing a significant treatment advantage for older patients who received dexmedetomidine. Consequently, the colleagues in this study-consortium are now seeking to conduct the largest prospective, randomized controlled trial on the use of dexmedetomidine for the treatment of critically ill older patients, with the participation of transcontinental centers. The primary objective of this study is to validate the hypothesis that older patients who receive early administration of dexmedetomidine, in comparison to standard sedatives, show lower mortality rates. Through the current proposal, we aim to facilitate the involvement of German medical centers in this highly significant clinical trial, enabling us to gain insights into the role of dexmedetomidine in the early treatment of critically ill, vulnerable patients within the German system of intensive care medicine.
DFG Programme
Clinical Trials
