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Study of intranasal insulin to prevent delirium in patients aged 65 years or older following elective cardiac surgery

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study investigates the use of intranasal insulin, which is a form of insulin human delivered through a nasal spray, to prevent delirium. Delirium is a state of sudden confusion and changes in mental awareness that can occur in people recovering from major medical procedures. The research focuses on patients aged 65 and older who are undergoing elective cardiac surgery, which is a planned operation on the heart, and require the use of a cardiopulmonary bypass machine to help circulate blood during the procedure.

The purpose of the study is to evaluate how well the nasal spray can be used and if it helps prevent confusion in these patients. During the trial, some individuals will receive the insulin human spray, while others will receive a placebo containing sodium chloride. This comparison helps to determine if the medication has a real effect compared to a substance that does not contain the active medicine.

Participants in the study will be monitored during their stay in the intensive care unit, also known as the ICU, which is a specialized hospital area for patients requiring constant, close monitoring. The course of the study involves observing the patients after their surgery to check for any side effects, such as hypoglycaemia, which is a condition where blood sugar levels become too low, as well as tracking the severity and duration of any mental confusion.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Administration of treatment
After participating in the study, a nasal spray is administered. this spray contains either the test medication, which is insulatard (a form of insulin), or a placebo, which is a sodium chloride (saltwater) solution.
If the test medication is received, the dose is 40 international units delivered via intranasal use (through the nose).
If the placebo is received, the dose is 0.4 ml delivered via intranasal use (through the nose).
Step 2
Monitoring and assessments
During the stay in the intensive care unit (icu), which is a specialized hospital area for intensive monitoring, delirium (a state of confusion) is assessed to measure its severity, how often it occurs, and how long it lasts.
The body is monitored for any local nasal adverse events, such as irritation or epistaxis (nosebleeds), and for hypoglycaemia (low blood sugar).
The use of antipsychotics, sedatives (medications used to calm or induce sleep), and benzodiazepines (a type of medication used to reduce anxiety or induce sleep) is recorded.
The length of the stay in the intensive care unit (icu) and the general hospital is recorded.
Step 3
Cognitive follow-up
A cognitive function assessment, which measures mental processes like thinking and memory, is performed 30 days after surgery using a specific interview method.

Who can join the trial?

7 criteria

You must be 65 years of age or older.
You must be scheduled for admission to the Intensive Care Unit (ICU), which is a specialized hospital area for patients needing constant, close monitoring, following a complex heart surgery.
The surgery must involve cardiopulmonary bypass (CPB), a procedure where a machine takes over the function of the heart and lungs during surgery.
The surgery is considered complex if it involves multiple procedures, such as coronary artery bypass grafting (CABG)—which is a surgery to improve blood flow to the heart—combined with a valve repair or replacement, or if it involves surgery on the aorta, which is the main large artery in the body.
The surgery is also considered complex if the estimated time using the cardiopulmonary bypass (CPB) machine is 90 minutes or longer.
You must be able to use an intranasal spray, which means a medicine sprayed into the nose, and you must not have any nasal pathology, which refers to physical problems or blockages in the nose that would stop the spray from working.
You or your legal representative must provide informed consent, which means you have been given all the necessary information about the study and have officially agreed to participate.

Who cannot join the trial?

4 criteria

You have delirium, which is a sudden state of confusion or disorientation, or dementia, which is a long-term decline in memory and thinking skills, at the start of the study.
You have undergone a specific type of heart surgery, such as a single-vessel CABG (a procedure to bypass one blocked artery), a single valve replacement or repair, or off-pump cardiac surgery (heart surgery performed while the heart is still beating).
You have a known allergy or hypersensitivity, which means your body has an abnormal reaction, to insulin or any of the other ingredients used to make the medicine.
You have a reason why medicine cannot be given through the nose, such as severe nasal pathology (serious problems or diseases in the nose), recent nasal or sinus surgery, active epistaxis (current nosebleeds), active rhinitis (inflammation or swelling inside the nose), or a blockage in one or both nostrils.

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Verified sites

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Verified
Stichting Radboud University Medical Center
Nijmegen, The Netherlands

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Investigated drugs

Insulin is a hormone that helps control blood sugar levels in the body. In this study, it is being tested through the nose to see if it can help prevent confusion or delirium in patients recovering from heart surgery.

What is already known about the treatment

Insulatard
This medication is a human insulin suspension administered through a nasal spray for use in this study. While widely used as an injectable treatment for diabetes to help regulate blood sugar, it is being investigated here for its potential to protect the brain. At a molecular level, it works by binding to specific receptors in the brain to improve how cells use energy and communicate. It is classified as a hormone used to manage glucose levels.
Natriumchloride
This is a simple salt solution administered through a nasal spray as a placebo for this trial. It is a standard, well-known substance used in medicine to balance fluids and electrolytes in the body. It does not have a specific drug-like mechanism of action for treating diseases but serves as a neutral substance to compare against the active medication. It is pharmacologically classified as a saline solution used for hydration and rinsing.

Investigated diseases

Delirium - This condition is characterized by a sudden and significant change in mental function and awareness. It often causes confusion, disorientation, and difficulty paying attention. The symptoms can fluctuate throughout the day, sometimes appearing more severe at night. It typically develops quickly, often in response to physical illness, surgery, or a change in the hospital environment. As it progresses, a person may experience hallucinations or become increasingly agitated.