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

Delirium Clinical Trial

Official title:

Non Invasive Monitoring of Cerebral Blood Flow During and After Cardiopulmonary Bypass to Assess and Compare for the Presence of Delirium in Post Operative Patients (DELIRIUM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02084394
• Other study ID #: NA_0007115
• Status: Completed
• Phase: Phase 4
• First received: February 25, 2014
• Last updated: February 5, 2016
• Start date: June 2013
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

Description:

Cardiac surgery is associated with multiple perturbations that increase risk for adverse postoperative neurological outcomes including postoperative cognitive dysfunction. These same perturbations likely also increase the risk for postoperative delirium although there are little data that have evaluated this hypothesis.

As the subject is prepared for surgery 2 contact probes will be placed on the forehead to monitor the rSO2 and cerebral blood flow. This monitor can also measureblood flow velocity in blood vessels in the forehead.

This will only be done while the subject is on the cardiac bypass machine during the surgery and end shortly after entering the intensive care unit.Prior to surgery and then once a day on three of the first four postoperative days, patients will be assessed for the presence and severity of delirium with brief standard psychological exams. We will compare rSO2 and CBF changes between patients with and without delirium

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: February 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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-

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Delirium

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Ornim Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Can CBF autoregulation can be monitored using ultrasound compared with TCD	To assess whether CBF autoregulation can be monitored using ultrasound tagged light methodology compared with TCD	3 days post op	No
Other	To evaluate the incidence of delirium in patients with impaired autoregulation	To evaluate the incidence of delirium in patients with impaired autoregulation	3 days post op	No
Primary	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	No
Secondary	recovery pattern of rSO2	To evaluate the recovery pattern of rSO2 and CBF for up to 6 hrs after CPB for ICU patients who experience delirium within three days after cardiac surgery compared with patients without delirium.	3 post op days	No