INSULIN HUMAN for Delirium

Inclusion criteria

• {"criterion_text":"- Age ≥65 years\n- Planned surgical admission to the ICU of the Radboudumc following complex cardiac surgery with CPB. Complex surgery is defined as: combined procedures (e.g., multi-vessel CABG or single CABG + valve replace-ment/repair); or aortic surgery (ascending aorta, arch, or root) or repair of aortic dissection; or expected CPB duration ≥ 90 minutes, as estimated preoperatively\n- Able to receive intranasal spray (no obstructive nasal pathology precluding administration)\n- Informed consent from patient"}

Exclusion criteria

• {"criterion_text":"- Delirium or dementia present at baseline\n- Single-vessel CABG, single valve replacement/repair or off-pump cardiac surgery\n- Known allergy/hypersensitivity to insulin or formulation excipients\n- Contra-indication for nasal administration (severe nasal pathology, recent nasal/sinus sur-gery, active epistaxis, active rhinitis, obstruction of either one or both nostrils)"}

Primary endpoints

• {"endpoint_text":"- 1) Feasibility, 2) tolerability and 3) exploratory efficacy, defined as: 1) Recruitment rate, protocol adherence (number of administered doses divided by number of planned doses), participant retention, follow-up completeness and effectiveness of blinding; 2) Local nasal adverse events (e.g., irritation, epistaxis) and incidence of hypoglycaemia, defined as the number of local nasal adverse events and hypoglycaemia events; 3) Delirium severity (DRS-R-98)","definition_or_measurement_approach":"Feasibility: recruitment rate, protocol adherence (number of administered doses / number of planned doses), participant retention, follow-up completeness, effectiveness of blinding; Tolerability: local nasal adverse events (e.g., irritation, epistaxis) and incidence of hypoglycaemia (number of events); Exploratory efficacy: Delirium severity measured by DRS-R-98."}

Secondary endpoints

• {"endpoint_text":"- Delirium incidence, dichotomous, defined as >= 1 positive delirium assessment(s)","definition_or_measurement_approach":"Dichotomous outcome: defined as ≥1 positive delirium assessment(s)."}
• {"endpoint_text":"- Delirium duration, defined as number of days with positive delirium assessment","definition_or_measurement_approach":"Number of days with a positive delirium assessment."}
• {"endpoint_text":"- Delirium and coma-free days, defined as number of days without delirium or coma","definition_or_measurement_approach":"Count of days without delirium or coma."}
• {"endpoint_text":"- Antipsychotic, sedative and benzodiazepine exposure, defined as number of patients receiving antipsychotics, sedatives, or benzodiazepines.","definition_or_measurement_approach":"Number of patients receiving antipsychotics, sedatives, or benzodiazepines."}
• {"endpoint_text":"- Length of ICU and hospital stay, defined as days spent in ICU and hospital","definition_or_measurement_approach":"Days spent in ICU and days spent in hospital."}
• {"endpoint_text":"- Change in cognitive function, assessed with the modified Telephone Interview for Cognitive Status (TICS m) at baseline (2 weeks prior to hospital admission) and 30 days after surgery","definition_or_measurement_approach":"Change in TICS-m score between baseline (approximately 2 weeks prior to admission) and 30 days post-surgery."}

Netherlands

Earliest CTIS Part Ii Submission Date

23-03-2026

Latest Decision Or Authorization Date

30-03-2026

Processing Time Days

7

Number Of Sites

1

Number Of Participants

30

Primary sponsor

Full Name

Radboud universitair medisch centrum Stichting

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands