Overview
Sponsor-declared trial summary
Delirium
This study aims to assess the feasibility, tolerability, and preliminary exploratory efficacy of intranasal insulin to prevent delirium in ICU patients aged ≥65 years after complex elective cardiac surgery with cardiopulmonary bypass.
Key facts
- Sponsor
- Radboud universitair medisch centrum Stichting
- Participant type
- Patients
- Age range
- 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 29 Apr 2026 → ongoing
- Decision date (initial)
- 2026-03-30
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
This study aims to assess the feasibility, tolerability, and preliminary exploratory efficacy of intranasal insulin to prevent delirium in ICU patients aged ≥65 years after complex elective cardiac surgery with cardiopulmonary bypass.
Conditions and MedDRA coding
Delirium
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Age ≥65 years
- 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
- Able to receive intranasal spray (no obstructive nasal pathology precluding administration)
- Informed consent from patient
Exclusion criteria 4
- Delirium or dementia present at baseline
- Single-vessel CABG, single valve replacement/repair or off-pump cardiac surgery
- Known allergy/hypersensitivity to insulin or formulation excipients
- Contra-indication for nasal administration (severe nasal pathology, recent nasal/sinus sur-gery, active epistaxis, active rhinitis, obstruction of either one or both nostrils)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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)
Secondary endpoints 6
- Delirium incidence, dichotomous, defined as >= 1 positive delirium assessment(s)
- Delirium duration, defined as number of days with positive delirium assessment
- Delirium and coma-free days, defined as number of days without delirium or coma
- Antipsychotic, sedative and benzodiazepine exposure, defined as number of patients receiving antipsychotics, sedatives, or benzodiazepines.
- Length of ICU and hospital stay, defined as days spent in ICU and hospital
- 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
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Insulatard 100 international units/ml suspension for injection in vial.
PRD322735 · Product
- Active substance
- Insulin Human
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRANASAL USE
- Max daily dose
- 40 IU international unit(s)
- Max total dose
- 200 IU international unit(s)
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- A10AC01 — INSULIN (HUMAN)
- Marketing authorisation
- EU/1/02/233/003
- MA holder
- NOVO NORDISK A/S
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Natriumchloride 0,9% oplossing voor injectie
PRD11910266 · Product
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRANASAL USE
- Max daily dose
- 0.4 ml millilitre(s)
- Max total dose
- 2 ml millilitre(s)
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05XA03 — SODIUM CHLORIDE
- Marketing authorisation
- RVG 57789
- MA holder
- FRESENIUS KABI NEDERLAND B.V.
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Radboud universitair medisch centrum Stichting
- Sponsor organisation
- Radboud universitair medisch centrum Stichting
- Address
- Geert Grooteplein Zuid 10
- City
- Nijmegen
- Postcode
- 6525 GA
- Country
- Netherlands
Scientific contact point
- Organisation
- Radboud universitair medisch centrum Stichting
- Contact name
- Mark van den Boogaard
Public contact point
- Organisation
- Radboud universitair medisch centrum Stichting
- Contact name
- Mark van den Boogaard
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 30 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2026-04-29 | 2026-04-30 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ Protocol 2025-524680-21_redacted | 2 |
| Protocol (for publication) | D4_ Patient facing documents DRS-R-98 | 1 |
| Protocol (for publication) | D4_ Patient facing documents TICS-M | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment_procedure | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults patient | 4 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SPC Insulatard | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_ENG 2025-524680-21 | 2 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_NL 2025-524680-21 | 2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-12-12 | Netherlands | Acceptable 2026-03-30
|
2026-03-30 |