Intranasal Insulin to Prevent Intensive Care Unit Delirium

Phase 3Not Yet RecruitingNCT07532577

Radboud University Medical Center30 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Delirium - Postoperative

Interventions

Intranasal insulin-40UDRUG

Intranasal isophane insulin administered twice daily. Each administration consists of two sprays of 10 IU (0.1 ml) in alternating nostrils, totalling to 40 IU per day.

Intranasal sodium chloride 0.9%DRUG

Intranasal sodium chloride 0.9% administered twice daily. Each administration consists of two sprays of 0.1 ml in alternating nostrils, totalling to 0.4mL per day.

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ≥65 years 2. 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 3. Able to receive intranasal spray (no obstructive nasal pathology precluding administration) 4. Informed consent from patient Exclusion Criteria: 1. Delirium at hospital admission 2. Non-complex or off-pump cardiac surgery 3. Known allergy/hypersensitivity to insulin or formulation excipients 4. Contra-indication for nasal administration (severe nasal pathology, recent nasal/sinus surgery, active epistaxis, active rhinitis, obstruction of either one or both nostrils) 5. Participating in other investigational medication trial

Locations (1)

Radboud University Medical Center

Nijmegen, Gelderland, Netherlands

Outcomes

Primary Outcomes

Feasibility: rate of recruitment

Proportion of eligible patients who are enrolled and randomized during the recruitment period.

Time frame: From start of study to end of study, with a maximum of 12 months

Feasibility: protocol adherence

Number of administered doses divided by number of planned doses

Time frame: From start of treatment up to a maximum of 5 days

Feasibility: participant retention and follow-up completeness

Proportion of randomized participants completing in-hospital data collection and 30-day follow-up (TICS-m).

Time frame: From start of study to end of study, with a maximum of 12 months

Tolerability

\- Local nasal adverse events (e.g., irritation, epistaxis) and incidence of hypoglycaemia (mild: glucose \<4.1 mmol/L, severe: \<2.2 mmol/L), defined as the number of local nasal adverse events and hypoglycaemia events.

Time frame: From start of treatment up to a maximum of 5 days

Exploratory efficacy

Delirium severity as assessed with the Delirium Rating Scale-Revised-98 (DRS-R-98)

Time frame: From start of treatment up to a maximum of 7 days

Secondary Outcomes

Delirium incidence

Defined as \>= 1 positive delirium assessment(s)

Time frame: From start of treatment up to a maximum of 7 days

Delirium severity

Numeric, as assessed with the Delirium Rating Scale-Revised-98 (DRS-R-98)

Time frame: From start of treatment up to a maximum of 7 days

Central Contacts

Rens Kooken, MD

CONTACT

+3124361673 rens.kooken@radboudumc.nl

Data from ClinicalTrials.gov

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