Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Intranasal insulinExperimental treatment 1 intervention
Group B: Intranasal placebo (NaCl 0.9%)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

Delirium incidence

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

Time frame
From start of treatment up to a maximum of 7 days
2

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
3

Delirium duration

Defined as number of days with positive delirium assessment

Time frame
From start of treatment up to a maximum of 7 days
4

Delirium and coma-free days

Defined as the number of days without delirium or coma

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Radboud University Medical Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: