Intranasal Insulin to Prevent Intensive Care Unit Delirium
ConditionDelirium - Postoperative
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age65+
SponsorRadboud University Medical Center
About this trial
This study aims to assess the feasibility, tolerability, and exploratory efficacy of intranasal insulin to prevent delirium in ICU patients aged ≥65 years after complex elective cardiac surgery with cardiopulmonary bypass
Eligibility criteria
Qualifiers
Age ≥65 years
Planned surgical admission to the ICU of the Radboudumc following complex cardiac surgery with CPB. Complex cardiac surgery is defined as all cardiac on-pump procedures except for isolated CABG
Able to receive intranasal spray (no obstructive nasal pathology precluding administration)
Informed consent from patient
Disqualifiers
Delirium at hospital admission
Non-complex or off-pump cardiac surgery
Known allergy/hypersensitivity to insulin or formulation excipients
Contra-indication for nasal administration (severe nasal pathology, recent nasal/sinus surgery, active epistaxis, active rhinitis, obstruction of either one or both nostrils)
Trial design
Treatments tested in this trial
- Intranasal insulin-40U
- Intranasal sodium chloride 0.9%
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov