Neuroinflammation and Postoperative Delirium in Cardiac Surgery

NCT02688179 | Completed DMC

• 1 other identifier: 160032
• Study Type: observational
• Target: 630
• Locations: 1 country
• Sites: 1

Brief Summary

Up to 50% of patients over 60 years old develop postoperative delirium following cardiac surgery. Delirium increases morbidity and mortality, and may lead to long-term cognitive impairment similar to patients with a diagnosis of Alzheimer's disease. The underlying mechanisms behind delirium are not understood, and therefore the current prevention and treatment strategies are inadequate. Several hypotheses exist for the pathophysiology of delirium, one of which is the role of neuroinflammation. The stress associated with high-risk procedures such as cardiac surgery may lead to systemic inflammation causing endothelial dysfunction and disruption of the blood brain barrier (BBB). When this occurs, the brain is susceptible to neuronal injury via neuroinflammation after which a state of delirium may ensue. To characterize the mechanisms of neuroinflammation in delirium, the investigators will explore the biomarkers most closely linked to each step of the proposed pathway.

Conditions

Delirium; Cardiac Surgery

Outcome Measures

Primary Outcomes (3)

• change in endothelial dysfunction

  biomarker of endothelial dysfunction to be measured at 3 time points

  baseline, postoperative day 0, postoperative day 1

• change in blood brain barrier disruption

  biomarker of blood brain barrier disruption to be measured at 3 time points

  baseline, postoperative day 0, postoperative day 1

• change in neuronal injury

  biomarker of neuronal injury to be measured at 3 time points

  baseline, postoperative day 0, postoperative day 1

Secondary Outcomes (1)

• delirium as screened with CAM-ICU

  twice daily after surgery until discharge from ICU (12 hours, 24 hours, 36 hours, 48 hours, 60 hours, 72 hours, 84 hours, 96 hours, continuing every 12 hours up to 24 weeks)

Study Arms (1)

Cardiac surgery patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients over the age of 18 undergoing open heart surgery

You may qualify if:

• open heart surgery

You may not qualify if:

• acute coronary syndrome with troponin leak or unrelenting angina
• liver dysfunction (transaminases 2x normal)
• history of myopathy or liver dysfunction on prior statin therapy
• use of potent CYP3A4 inhibitors such as antifungal azoles, macrolide antibiotics, HIV protease inhibitors, and nefazodone.
• pregnancy or breast feeding
• cyclosporine use
• dialysis
• history of kidney transplant
• fibrate users who cannot stop fibrate use

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2016
• First Posted: February 23, 2016
• Study Start: January 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: September 17, 2018

Record last verified: 2018-09

Locations

US (1)