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Goal directed therapy (GDT) for Delirium (HDBRAIN Trial)

N/A

Waitlist Available

Led By Rajesh Kumar, PhD

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months post surgery

Awards & highlights

HDBRAIN Trial Summary

This trial will study the effects of different anesthesia care on postoperative cognitive decline and delirium. 60 patients will be enrolled and assessed before and after surgery for cognitive changes. An fMRI will also be done before and after surgery.

Eligible Conditions

Postoperative Delirium
Postoperative Cognitive Dysfunction
Obstructive Sleep Apnea

HDBRAIN Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months post surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months post surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Postoperative Delirium

Postoperative cognitive dysfunction

Secondary outcome measures

Blood anti-inflammatory biomarkers

Examining brain changes

Examining brain changes II

+1 more

HDBRAIN Trial Design

1Treatment groups

Experimental Treatment

Group I: InterventionExperimental Treatment1 Intervention

Patients monitored and receiving a standard anesthesia plan in addition of a goal directed therapy (GDT) hemodynamic management (MAP > 60 mmHg) and processed EEG-guided anesthesia (PSI targeted between 30-50).

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Who is running the clinical trial?

University of California, Los AngelesLead Sponsor

1,528 Previous Clinical Trials

10,276,844 Total Patients Enrolled

2 Trials studying Delirium

24,426 Patients Enrolled for Delirium

Rajesh Kumar, PhDPrincipal InvestigatorUniversity of California, Los Angeles

2 Previous Clinical Trials

102 Total Patients Enrolled

Susana Vacas, M.D., Ph.D.Principal Investigator - Massachusetts General Hospital

University of California, Los Angeles

1 Previous Clinical Trials

34 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have decided to join this experiment?

"Affirmative. The details posted on clinicaltrials.gov inform us that this trial is presently enrolling participants, having first been made available on January 30th 2020 and last updated on May 16th 2022. 60 patients are needed to be recruited from 1 medical centre."

Answered by AI

What aims does this clinical research endeavor to achieve?

"This study aims to assess Postoperative Cognitive Dysfunction (POCD) over a three-day period, with secondary objectives of examining brain changes via non-invasive Magnetic Resonance Imaging based Diffusion Tensor Imaging and measuring blood anti-inflammatory biomarkers such as Interleukins 6, 10, tumor necrosis factor alpha, interleukin 1 beta and high mobility group box 1."

Answered by AI

Will I be eligible to partake in this research?

"Individuals between 45 and 75 years old, who have been clinically diagnosed with obstructive sleep apnea qualify for this study. Around 60 participants are needed to be recruited in total."

Answered by AI

Does this clinical trial extend its inclusion criteria to seniors of a certain age?

"The age range of applicants eligible for this trial is 45 to 75. In contrast, there are 74 clinical trials specifically designed for patients below 18 years old and 840 active studies suitable for those over 65."

Answered by AI

Are investigators still in the process of enrolling participants for this experiment?

"The clinical trial is currently enrolling participants, per the details of its listing on clinicialtrials.gov. This medical experiment was initially posted at the end of January 2020 and underwent an update in mid-May 2022."

Answered by AI

Recent research and studies

AnesthesiologyJournal

Anesthetic Management Using Multiple Closed-loop Systems and Delayed Neurocognitive Recovery

Joosten, Alexandre, Joseph Rinehart, Aurélie Bardaji, Philippe Van der Linden, Vincent Jame, Luc Van Obbergh, Brenton Alexander, et al.. 2020. “Anesthetic Management Using Multiple Closed-loop Systems and Delayed Neurocognitive Recovery”. Anesthesiology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/aln.0000000000003014.

Journal of Cardiothoracic and Vascular AnesthesiaJournal

Noninvasive Monitoring and Potential for Patient Outcome

Vacas, Susana, and Maxime Cannesson. 2019. “Noninvasive Monitoring and Potential for Patient Outcome”. Journal of Cardiothoracic and Vascular Anesthesia. Elsevier BV. doi:10.1053/j.jvca.2019.03.045.

clinicaltrials.govStudy

Taking Brain Monitoring to the Next Level

Rajesh Kumar, PhD 2020. "Taking Brain Monitoring to the Next Level". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04246320.