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NCT Number: NCT07532577

Intranasal Insulin to Prevent Intensive Care Unit Delirium

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

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Key information

Conditions

Delirium - Postoperative Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Radboud University Medical Center

Nijmegen, Gelderland, 6525GA, Netherlands

Location contact

Rens Kooken, MD

CONTACT

[email protected]

+3124361673

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)
  • Participating in other investigational medication trial

Treatment and study plan

Intranasal insulin-40U

Drug

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.

Primary outcomes

  1. Feasibility: rate of recruitment

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

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

  2. Feasibility: protocol adherence

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

    Number of administered doses divided by number of planned doses

  3. Feasibility: participant retention and follow-up completeness

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

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

  4. Tolerability

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

    • 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.

  5. Exploratory efficacy

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

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

Secondary outcomes

  1. Delirium incidence

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

    Defined as >= 1 positive delirium assessment(s)

  2. Delirium severity

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

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

  3. Delirium duration

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

    Defined as number of days with positive delirium assessment

  4. Delirium and coma-free days

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

    Defined as the number of days without delirium or coma

  5. Exposure to antipsychotics, sedatives and benzodiazepines

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

    Defined as the number of patients receiving antipsychotics, sedatives, or benzodiazepines

  6. Length of ICU stay

    Time frame: From ICU admission to ICU discharge, assessed up to 6 months

    Defined as days spent in the ICU

  7. Length of hospital stay

    Time frame: From hospital admission to discharge, assessed up to 6 months

    Defined as days spent in the hospital

  8. Change in cognitive function

    Time frame: From informed consent to 30 days post-surgery

    Assessed with the modified Telephone Interview for Cognitive Status (TICS-m) at baseline (before hospital admission) and 30 days after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Rens Kooken, MD

CONTACT

[email protected]

+3124361673

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

Intranasal Insulin for the Prevention of Delirium in ICU Patients Undergoing Elective Cardiac Surgery: a Randomized, Double-blind, Placebo-controlled Pilot Trial (INSPIRE)

Acronym: INSPIRE

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 16, 2026
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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