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DeliriumNCT06748391

Nitric Oxide Levels Were Associated With Postoperative Delirium Following Cardiac Surgery

An observational study of Delirium and Post-operative Delirium, run by Tongji Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a single-center prospective observational study conducted at the operating room, post-anesthesia care unit, and ICU of Tongji Hospital, from April 2023 to September 2024. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Delirium, Post-operative Delirium
How many people
1,939 participants
Where
1 siteChina
Study dates
1 Jan 2018to 30 Sep 2024
Phase
Observational
Are there results?
None posted in the registry

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

Study population: The study comprised a derivation cohort and a validation cohort. Clinical data and prognostic details of patients were extracted from three medical centers at Tongji Hospital. The derivation cohort was retrospectively gathered from the hospital's electronic medical records, encompassing the period from January 2018 to January 2023, employing K-Means clustering to reveal potential nutritional subtypes among cardiovascular surgery patients. Subsequently, the correlation between these subtypes and POD was validated in an independent prospective cohort study. The validation cohort data was derived from a prospective cohort study, spanning from April 2023 to September 2024.

Who may be able to join

  • Adult patients undergoing cardiac surgery

Who cannot join

  • 1) minors under the age of 18; 2) pregnant women; 3) individuals with preexisting preoperative delirium or a history of psychiatric disorders like schizophrenia and major depressive conditions; 4) those with an extensive history of psychotropic medications; 5) Use of nitrates after admission; 6) patients with significant neurological disorders, such as severe traumatic brain injuries or recent strokes within the past 6 months.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430030

Other trials in China

About this study

Official title: Identifying Nitric Oxide Levels as Predictors of Postoperative Delirium in Following Cardiac Surgical Patients

This study is a single-center prospective observational study conducted at the operating room, post-anesthesia care unit, and ICU of Tongji Hospital, from April 2023 to September 2024.

Read the detailed description

The study focused on adult patients undergoing cardiac surgery. Patients meeting the following criteria were excluded from the study: 1) age ≤ 18; 2) pregnant women; 3) individuals with preexisting preoperative delirium or a history of psychiatric disorders like schizophrenia and major depressive conditions; 4) those with an extensive history of psychotropic medications; 5) Use of nitrates after admission; and 6) patients with significant neurological disorders, such as severe traumatic brain injuries or recent strokes within the past 6 months. Blood samples were collected from patients at three different time points - pre-surgery after fasting, during surgery, and 24 hours post-surgery. These samples were stored in a central biobank at -80°C for future analysis. Details regarding the type and duration of anesthesia administered were also documented. Plasma nitric oxide (NO) levels were assessed using ethylenediaminetetraacetic acid whole blood samples (BTK074, Bio-swamp, Wuhan, China), with specific assay protocols accessible at https://www.bio-swamp.com/goodsDetail/BTK074.

Collection of research variables The research variables comprised nutritional indices, encompassing fasting blood glucose (GLU), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC), triglycerides (TG), albumin (ALB), and lymphocyte count (LYC). Initial test results for these indices were obtained within 48 hours of each patient's hospital admission. In instances where data was missing, the corresponding values recorded in the patient's medical records within the past 6 months were utilized. Furthermore, additional clinical data included gender, age, comorbidities, and treatment protocols. Comorbidities assessed comprised hypertension, diabetes, chronic lung disease, and chronic renal failure. Chronic lung diseases encompassed chronic obstructive pulmonary disease, bronchial asthma, chronic bronchitis, and bronchiectasis.

Definition and setting of clinical outcomes The primary outcome, set as patients developing POD within 7 days post-surgery or before discharge, was assessed. In the derivation cohort, delirium diagnosis relied on documented POD in the medical records. If not explicitly stated, POD presence was determined based on the Confusion Assessment Method for Intensive Care Unit (CAM-ICU) results as recorded in nursing documentation. In the prospective cohort, trained physicians utilized the CAM-ICU protocol to assess patients' consciousness at 6-hour intervals for up to 7 days postoperatively, classifying a patient with positive CAM-ICU at least once during this period or before discharge as having POD.

Secondary outcomes included common postoperative adverse events such as prolonged mechanical ventilation (MV) (defined as continuous mechanical ventilation for ≥72 hours post-surgery), in-hospital all-cause mortality, and the occurrence of postoperative pulmonary complications (e.g., respiratory infection, respiratory failure, pleural effusion, pulmonary atelectasis, pneumothorax, bronchospasm, and aspiration pneumonia). Data collection and diagnostic processes were conducted independently by two researchers, with discrepancies resolved by a third researcher to ensure accuracy and consistency.

Machine Learning Processes Machine learning techniques were implemented using Python (version 3.13.0, Python Software Foundation). Data preprocessing commenced, starting with outlier processing using the 99% Winsorisation technique to address outliers' impact on the results. StandardScaler was then applied to normalize the dataset. Spearman's correlation coefficient was employed to evaluate the correlation among dataset features, visualized using a heatmap. The K-Means clustering algorithm, a pivotal unsupervised learning method, was utilized[15]. K-Means models were trained on derived cohorts, and the silhouette coefficient method determined the optimal cluster number for robust clustering outcomes. The validation set data underwent classification using the pre-trained K-Means model to predict cluster labels for each sample point.

Keywords
Delirium, NO, Nutritional and Metabolic Subtypes
Medical subject headings
Delirium, Emergence Delirium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06748391
Study groupRoleWhat they receive
Cardiac SurgeryThe study focused on adult patients undergoing cardiovascular surgery. Patients meeting the following criteria were excluded from the study: 1) minors under the age of 18; 2) pregnant women; 3) individuals with preexisting preoperative delirium or a history of psychiatric disorders like schizophrenia and major depressive conditions; 4) those with an extensive history of psychotropic medications; 5) Use of nitrates after admission; and 6) patients with significant neurological disorders, such as severe traumatic brain injuries or recent strokes within the past 6 months.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative Delirium

    The Confusion Assessment Method for the ICU (CAM-ICU) is a validated tool used to assess delirium in critically ill patients. It includes a series of cognitive assessments and observations to determine the presence of delirium based on specific criteria. Scores indicate the level of confusion, with higher scores reflecting worse outcomes. For the CAM-ICU, the score typically ranges from 0 to 3, where:

    0 = no delirium

    1. = possible delirium
    2. = probable delirium
    3. = definite delirium

    Measured: 7 dyas

Secondary outcomes (1)
  1. Mortality

    Questionnaire

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Dec 2024
  2. Study start1 Jan 2018
  3. Primary completion1 Jan 2024
  4. Study completion30 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
1,939 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06748391
Sponsor's protocol ID
TJ-IRB20231166
Status last verified
Jan 2025
First submitted
19 Dec 2024
Last updated
20 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Delirium and Post-operative Delirium, run by Tongji Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative Delirium (time frame: 7 dyas). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025.

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