Cardiac Surgery With Cardiopulmonary BypassNCT07893353
Mechanisms and Intervention Strategies of Perioperative Glycemic Variability on Postoperative Delirium
A study testing Intranasal insulin-20U, Intranasal insulin-40U and Intranasal Saline in people with Cardiac Surgery With Cardiopulmonary Bypass and Postoperative Delirium, run by Fujian Medical University Union Hospital at 1 site in China.
Trial summary
Delirium is a sudden change in attention, thinking, and awareness that can occur after heart surgery. It may slow recovery and is associated with longer hospital stays and poorer health outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery With Cardiopulmonary Bypass, Postoperative Delirium
- What is being tested?
- Intranasal insulin-20U, Intranasal insulin-40U and Intranasal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 225 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2026to 31 Oct 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Scheduled for elective cardiac surgery with CPB
Who cannot join
- History of psychiatric disorders, neurological diseases, or mild cognitive impairment (MCI) (Mini-Cog score < 3)
- Severe diabetes mellitus
- Participation in other interventional studies
- Coexistence of severe organic diseases
- Nasal deformities, nasal diseases, or history of nasal surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350000
About this study
Official title: Mechanisms and Intervention Strategies of Perioperative Glycemic Variability on Postoperative Delirium After Cardiac Surgery
Delirium is a sudden change in attention, thinking, and awareness that can occur after heart surgery. It may slow recovery and is associated with longer hospital stays and poorer health outcomes. Patients undergoing heart surgery with cardiopulmonary bypass, also known as a heart-lung machine, may experience changes in blood sugar levels and in the body's response to insulin around the time of surgery.
This study aims to investigate how fluctuations in blood sugar levels, known as glycemic variability, are related to postoperative delirium. It will also examine whether insulin resistance, a condition in which the body responds less effectively to insulin, helps explain this relationship.
The study will evaluate intranasal insulin, which is insulin administered through the nose to reach the brain. Researchers will assess its effects on blood sugar fluctuations, insulin resistance, and the occurrence of postoperative delirium in patients undergoing heart surgery with cardiopulmonary bypass. The findings may help guide future approaches to protecting brain function and improving recovery after heart surgery.
- Being tested
- Intranasal insulin-20U, Intranasal insulin-40U, Intranasal Saline
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal insulin-20UDrug
Intranasal insulin intervention was administered by a trained nurse at a dose of 20IU. The timing and frequency of the intervention were as follows: twice daily starting from 2 days before surgery; one dose administered 60 minutes before anesthesia induction; and twice daily from postoperative day 1 to day 3. Safety monitoring during the intervention was performed by one cardiac surgeon.
Intranasal insulin-40UDrug
Intranasal insulin intervention was administered by a trained nurse at a dose of 40IU. The timing and frequency of the intervention were as follows: twice daily starting from 2 days before surgery; one dose administered 60 minutes before anesthesia induction; and twice daily from postoperative day 1 to day 3. Safety monitoring during the intervention was performed by one cardiac surgeon.
Intranasal SalineDrug
Intranasal saline was administered by a trained nurse at a dose of 1 mL per administration (0.5 mL per nostril). The timing and frequency of the intervention were as follows: twice daily starting 2 days before surgery; one dose given 60 minutes before anesthesia induction; and twice daily from postoperative day 1 to day 3. Safety monitoring during the intervention was performed by one cardiac surgeon.
| Study group | Role | What they receive |
|---|---|---|
| Group I-20 | Experimental | Intranasal insulin intervention was administered by a trained nurse at a dose of 0.5 mL per administration (0.25 mL per nostril). The timing and frequency of the intervention were as follows: twice daily starting from 2 days before surgery; one dose administered 60 minutes before anesthesia induction; and twice daily from postoperative day 1 to day 3. Safety monitoring during the intervention was performed by one cardiac surgeon. Receives: Drug: Intranasal insulin-20U |
| Group I-40 | Experimental | Intranasal insulin intervention was administered by a trained nurse at a dose of 1 mL per administration (0.5 mL per nostril). The timing and frequency of the intervention were as follows: twice daily starting from 2 days before surgery; one dose administered 60 minutes before anesthesia induction; and twice daily from postoperative day 1 to day 3. Safety monitoring during the intervention was performed by one cardiac surgeon. Receives: Drug: Intranasal insulin-40U |
| Control group | Placebo comparator | Intranasal saline was administered by a trained nurse at a dose of 1 mL per administration (0.5 mL per nostril). The timing and frequency of the intervention were as follows: twice daily starting 2 days before surgery; one dose given 60 minutes before anesthesia induction; and twice daily from postoperative day 1 to day 3. Safety monitoring during the intervention was performed by one cardiac surgeon. Receives: Drug: Intranasal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and Proportion of Participants with Postoperative Delirium Assessed Using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) Within 7 Days After Surgery
Postoperative delirium will be assessed using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) during postoperative days 1 through 7. The number and proportion of participants who develop postoperative delirium during this period will be reported. Delirium will be identified according to the CAM-ICU assessment criteria.
Measured: Postoperative days 1 through 7
Secondary outcomes (2)
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Baseline, at the End of Cardiopulmonary Bypass, and on Postoperative Days 1, 2, 3, and 7
Insulin resistance will be assessed using the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR). HOMA-IR will be calculated using blood glucose and insulin concentrations according to the prespecified study protocol. HOMA-IR values will be recorded at the preoperative baseline, at the end of cardiopulmonary bypass (CPB), and on postoperative days 1, 2, 3, and 7. The HOMA-IR values at each assessment time point will be reported.
Measured: Preoperative baseline, at the end of cardiopulmonary bypass, and postoperative days 1, 2, 3, and 7
Perioperative Glycemic Variability Assessed by Mean Blood Glucose (MBG), Coefficient of Variation (CV), Mean Absolute Glucose Measure, Derived Time in Range (dTIR), and Mean of Daily Differences (MODD)
Perioperative glycemic variability will be evaluated using blood glucose measurements obtained through intermittent sampling at prespecified time points. The assessment parameters will include mean blood glucose (MBG), coefficient of variation (CV), mean absolute glucose measure, derived time in range (dTIR), and mean of daily differences (MODD).
Blood glucose measurements will be collected at the following time points: preoperative baseline (fasting blood glucose on hospital admission day 1); 15 minutes before anesthesia induction; within the first hour after initiation of cardiopulmonary bypass (CPB); within 10 minutes after termination of CPB; and four times daily at 6-hour intervals on postoperative days 1 through 3.
Each glycemic variability parameter will be calculated according to the prespecified study protocol, and the corresponding values will be reported for the applicable assessment period.
Measured: Preoperative baseline; 15 minutes before anesthesia induction; within the first hour after initiation of CPB; within 10 minutes after termination of CPB; and postoperative days 1 through 3, with four measurements per day at 6-hour intervals.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start1 Mar 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Surgery With Cardiopulmonary BypassStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07893353
- Sponsor's protocol ID
- 2025KY727
- Status last verified
- Jul 2026
- First submitted
- 11 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No