NCT02548975

Brief Summary

This study will evaluate several potential risk factors for postoperative delirium in cardiac surgery patients. The risk factors will include use of specific preoperative, intraoperative, and/or postoperative medications. Other risk factors investigated may include exposure to cardiopulmonary bypass, surgical technique, and or duration of surgery.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2009

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 14, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

February 20, 2017

Status Verified

February 1, 2017

Enrollment Period

6.9 years

First QC Date

September 4, 2015

Last Update Submit

February 17, 2017

Conditions

Delirium

Keywords

Cardiac surgeryRisk factorsPostoperative delirium

Outcome Measures

Primary Outcomes (1)

  • Incidence of delirium

    CAM-ICU positive at any time after cardiac surgery

    During ICU stay, average may be 4 days

Secondary Outcomes (6)

  • Duration of delirium

    During ICU stay, average may be 4 days

  • In hospital and 30 day mortality

    During hospital admission and within 30 days of surgery

  • Acute kidney injury

    During hospital stay, average may be 1 week

  • Atrial fibrillation

    During hospital stay, average may be 1 week

  • Total length of stay

    During hospital stay, average may be 1 week

  • +1 more secondary outcomes

Study Arms (2)

Delirium

Patients diagnosed with delirium at any time postoperatively with the CAM-ICU.

Drug: Statin, beta blockerOther: Cardiopulmonary bypass

No delirium

Patients not diagnosed with delirium postoperatively.

Drug: Statin, beta blockerOther: Cardiopulmonary bypass

Interventions

Statin, beta blockerDRUG

Patients receiving either statin or beta blockers prior to cardiac surgery.

Also known as: Statin & beta blocker are the classes of drugs which will be included in the study and will include multiple generic medications in each of these drug clasess
DeliriumNo delirium
Cardiopulmonary bypassOTHER

Patients exposed to cardiopulmonary bypass during cardiac surgery.

DeliriumNo delirium

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Cardiac surgery patients over 18 years old at Vanderbilt University Medical Center

You may qualify if:

  • Patients undergoing elective cardiac surgery (coronary artery bypass grafting (CABG), CABG+valve(s), valve only)
  • \*depending on the study - OR aortic valve replacement (will include patients undergoing transcatheter aortic valve replacement (TAVR) and patients undergoing only aortic valve replacement with CPB)

You may not qualify if:

  • Emergency cases will be excluded.
  • \*depending on the study - Patients undergoing any valve replacement surgery other than aortic valve

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • O'Neal JB, Billings FT 4th, Liu X, Shotwell MS, Liang Y, Shah AS, Ehrenfeld JM, Wanderer JP, Shaw AD. Risk factors for delirium after cardiac surgery: a historical cohort study outlining the influence of cardiopulmonary bypass. Can J Anaesth. 2017 Nov;64(11):1129-1137. doi: 10.1007/s12630-017-0938-5. Epub 2017 Jul 17.

    PMID: 28718100DERIVED

MeSH Terms

Conditions

DeliriumEmergence Delirium

Interventions

Hydroxymethylglutaryl-CoA Reductase InhibitorsAdrenergic beta-AntagonistsCardiopulmonary Bypass

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersPostoperative ComplicationsPathologic Processes

Intervention Hierarchy (Ancestors)

Anticholesteremic AgentsHypolipidemic AgentsAntimetabolitesMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesEnzyme InhibitorsLipid Regulating AgentsTherapeutic UsesAdrenergic AntagonistsAdrenergic AgentsNeurotransmitter AgentsPhysiological Effects of DrugsExtracorporeal CirculationSurgical Procedures, Operative

Study Officials

  • Jason O'Neal, M.D.

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor in Clinical Anesthesiology

Study Record Dates

First Submitted

September 4, 2015

First Posted

September 14, 2015

Study Start

November 1, 2009

Primary Completion

October 1, 2016

Study Completion

November 1, 2016

Last Updated

February 20, 2017

Record last verified: 2017-02