Cerebral Blood Flow During CPB During Cardiac Surgery and the Presence of Post op Delirium

NCT02084394 | Completed

• 1 other identifier: NA_0007115
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiac surgery is associated with multiple events and issues that increase risk for adverse postoperative neurological outcomes including postoperative cognitive dysfunction. The risk for postoperative delirium is generally thought to result from some previous health factors added to the susceptibility of the cardiac surgery process.

Conditions

Delirium

Keywords

CBF autoregulation, rSO2,doppler, TCD, delirium,

Outcome Measures

Primary Outcomes (1)

• To evaluate whether rSO2 and/or CBF during CPB is lower in patients who experience delirium within three days after cardiac surgery compared with patients without delirium

  To evaluate whether rSO2 and/or CBF during CPB is lower in patients who experience delirium within three days after cardiac surgery compared with patients without delirium.

  3 days post op

Secondary Outcomes (1)

• recovery pattern of rSO2

  3 post op days

Other Outcomes (2)

• Can CBF autoregulation can be monitored using ultrasound compared with TCD

  3 days post op

• To evaluate the incidence of delirium in patients with impaired autoregulation

  3 days post op

Study Arms (1)

no intervention

Contact with enrolled subjects requires application of ceberal oximetry electrodes and the concommittent ultrasound of the temporal artery. Deemed interventional by JHUIRB but no actual intervention done to subject.

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who are under going cardiac bypass surgery with the use of cardiac perfusion

You may qualify if:

• Patients in the study will be 50 or older undergoing elective cardiovascular surgery using cardiopulmonary bypass.
• Patients who can speak, read and understand the English language.
• Patients who understand the nature of the study and are willing to sign the consent form

You may not qualify if:

• Emergency surgery or patients intubated before surgery and, thus, cannot give informed consent.
• Patients diagnosed with neurocognitive disorders (e.g. Alzheimer's, Dementia)
• MMSE score greater than 21 Patients taking antipsychotic drugs A history of drug abuse
• Patients with an implant in the brain underneath the CerOx probes
• Women who are pregnant.
• History of significant, prohibitive skin allergies or reactions-

Sponsors & Collaborators

• Johns Hopkins University: lead
• Ornim Medical: collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Delirium; Choroideremia

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Eye Diseases, Hereditary; Eye Diseases; Choroid Diseases; Uveal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, X-Linked

Study Officials

• Kaushik Mandal, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Division of Cardiac Surgery

Study Record Dates

• First Submitted: February 25, 2014
• First Posted: March 12, 2014
• Study Start: June 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: February 1, 2016
• Last Updated: February 9, 2016

Record last verified: 2016-02

Locations

US (1)