Efficacy and Tolerability of Intranasal Insulin for the Prevention of Delirium in Elderly Patients Following Elective Cardiac Surgery: A Randomized Controlled Pilot Trial

The primary objective is to evaluate the feasibility, tolerability, and preliminary exploratory efficacy of intranasal insulin for the prevention of delirium. This assessment is conducted in patients aged ≥65 years following complex elective cardiac surgery involving cardiopulmonary bypass within an intensive care unit setting. 5

The sponsor did not provide information regarding the total number of participants. The study population consists of patients aged 65 years or older who are scheduled for admission to the intensive care unit following complex elective cardiac surgery involving cardiopulmonary bypass. Included individuals are undergoing procedures such as combined operations, aortic surgery, or surgeries with a predicted bypass duration of at least 90 minutes. Participants must be able to utilize an intranasal spray without interference from obstructive nasal pathology. The investigation focuses on the prevention of delirium in this cohort.

This randomized, double-blind, placebo-controlled pilot trial is designed to evaluate the feasibility, tolerability, and preliminary exploratory efficacy of intranasal insulin for the prevention of delirium in intensive care unit patients aged 65 years or older following complex elective cardiac surgery involving cardiopulmonary bypass. Participants are assigned to receive either the test product, consisting of 40 IU of insulin human, or a placebo containing 0.4 ml of sodium chloride via intranasal administration. The study methodology includes a screening process to ensure eligibility based on age, surgical requirements, and the absence of obstructive nasal pathology. Primary endpoints focus on recruitment rates, protocol adherence, and the incidence of hypoglycaemia or local nasal adverse events such as epistaxis. Secondary endpoints involve the assessment of delirium incidence and duration, coma-free days, and changes in cognitive function measured via the modified Telephone Interview for Cognitive Status. The investigation encompasses baseline assessments, follow-up monitoring, and an end-of-study evaluation to determine the impact on length of hospital stay and pharmacological exposure to antipsychotics, sedatives, or benzodiazepines.

The experimental treatment consists of Insulatard, which is a suspension for injection containing human insulin at a concentration of 100 international units/ml. The administered dose is 40 IU via intranasal use.

The control group receives a placebo consisting of sodium chloride 0.9% solution for injection. The dosage is 0.4 ml administered via intranasal use.

The primary efficacy assessment focuses on the exploratory evaluation of delirium severity using the DRS-R-98. Secondary efficacy endpoints include the incidence of delirium, defined by the presence of one or more positive assessments, and the duration of the condition, measured by the number of days with positive delirium assessments. Additionally, delirium and coma-free days will be quantified as the total number of days without delirium or coma. The utilization of antipsychotics, sedatives, and benzodiazepines will be monitored based on the number of patients receiving these medications. The length of stay in the intensive care unit and the hospital will also be recorded. Changes in cognitive function will be evaluated using the modified Telephone Interview for Cognitive Status (TICS m) at baseline, occurring two weeks prior to hospital admission, and at 30 days post-surgery.