DeliriumNCT02548975
Risk Factors for Delirium Following Cardiac Surgery
An observational study of Delirium, run by Vanderbilt University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Delirium
- What is being tested?
- Statin, beta blocker and Cardiopulmonary bypass
- How many people
- 5,600 participants
- Where
- No sites listed yet
- Study dates
- Nov 2009to Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cardiac surgery patients over 18 years old at Vanderbilt University Medical Center
Who may be able to join
- 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)
Who cannot join
- Emergency cases will be excluded.
- depending on the study - Patients undergoing any valve replacement surgery other than aortic valve
About this study
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.
Read the detailed description
In order to understand the role of medication usage and/or cardiopulmonary bypass, the investigators propose to leverage the perioperative data warehouse (PDW), an IRB approved data registry, to retrospectively evaluate the subjects. All patient data available in the warehouse may be included in the review. At this time, there are approximately 750,000 patients in the PDW. All data will be accessed retrospectively after the patient has been seen for their care here at Vanderbilt.
The Vanderbilt Perioperative Information Management System (VPIMS) is part of an integrated system that covers the entire perioperative process including instrument \& supply management, scheduling, and status displays. Because of the extensive effort that has been put toward in-house intraoperative software development, the Vanderbilt Anesthesiology \& Perioperative Informatics Research (VAPIR) Division is able to benefit from the availability of thousands of historical intraoperative records, each containing detailed physiologic information. The PDW incorporates VPIMS and electronic healthcare records (EHR) to build its database. In addition to PDW, information from the Society for Thoracic Surgeons (STS) database will be used in our study.
The database uses algorithms created by programmers with the assistance clinicians to screen the data and assess for accuracy and completeness. Once the data is compounded and uploaded, each variable is screened for outliers by a clinician. Outliers will be assessed and validated by a clinician based on trends from the raw data. The data collected for this study includes an extensive data dictionary listed below:
variable teeid anescasenumber mrn date orintime orouttime age gender race hx_dialysis_vpec hx_dialysis_hemodialysis_vpec hx_dialysis_peritoneal_vpec hx_esrd creatinine_base creatinine_pod1 creatinine_pod2 creatinine_pod3 creatinine_pod4 creatinine_pod5 creatinine_pod6 creatinine_pod7 creatinine_pod8 creatinine_pod9 creatinine_pod10 hx_htn hx_mi ck_preop ckmb_preop troponin_preop hx_cabg hx_angioplasty hx_angina hx_chf hx_ef_less_35 hx_chf_recent_hospital hx_chf_stable hx_chf_currentsigns hx_afib hx_aflutter hx_carotid_disease_current hx_carotid_disease_past hx_dementia hx_depression hx_stroke hx_tia hx_claudication chol_base ldl_base hdl_base triglycerides_base hx_copd hx_emphysema hx_smoking_current hx_smoking_quitless3months hx_smoking_quitmore3months hx_osa hx_hypoxia_ra_sat_less92 hx_home_o2 diabetes hba1c charlson_index weight height bmi hct_base hb_base platelet_count_base hx_neoplasm statin_preopyesno clopidogrel_preop aspirin_preop betablocker_preop aceinhibitor_preop diuretic_preop preop_meds ph_intraop_first ph_intraop_last ph_intraop_min ph_intraop_max ph_intraop_median ph_intraop_count po2_intraop_first po2_intraop_last po2_intraop_min po2_intraop_max po2_intraop_median po2_intraop_count lactate_intraop_first lactate_intraop_last lactate_intraop_min lactate_intraop_max lactate_intraop_median lactate_intraop_count ebl_intraop hespan_intraop lr_intraop lr5dex_intraop ns_intraop plasmalyte_intraop input_intraop uop_intraop emergency_surgery procedure_cpt procedure_descriptor cabg_grafts cpb_on_time1 cpb_off_time1 cpb_on_time2 cpb_off_time2 cpb_on_time3 cpb_off_time3 cpb_on_time4 cpb_off_time4 cpb_on_time5 cpb_off_time5 cpb_duration cpb_duration_calculated cbp_recorded_matches_calculated ao_clamp_duration circ_arrest_duration ultrafiltration_volume pump_drugs uop_onpump prbc_intraop_ml prbc_intraop_unit ffp_intraop_ml ffp_intraop_unit platelets_intraop_ml platelets_intraop_unit cryo_intraop_ml cryo_intraop_unit prbc_postop ffp_postop platelets_postop cryo_postop ckmb_pod1 req_reop_24 req_reop_72 is_reop wbc_base wbc_pod1 wbc_pod2 wbc_pod3 wbc_pod4 wbc_pod5 wbc_pod6 wbc_pod7 wbc_pod8 wbc_pod9 wbc_pod10 ph_pod1 ph_pod2 ph_pod3 ph_pod4 ph_pod5 ph_pod6 ph_pod7 ph_pod8 ph_pod9 ph_pod10 lactate_pod1 lactate_pod2 lactate_pod3 lactate_pod4 lactate_pod5 lactate_pod6 lactate_pod7 lactate_pod8 lactate_pod9 lactate_pod10 pfratio_pod1 pfratio_pod2 pfratio_pod3 pfratio_pod4 pfratio_pod5 pfratio_pod6 pfratio_pod7 pfratio_pod8 pfratio_pod9 pfratio_pod10 creatinine_pod30 creatinine_pod60 creatinine_pod90 creatinine_pod365 dialysis_postop_predischarge dialysis_postop_pod30 dialysis_postop_pod60 dialysis_postop_pod90 dialysis_postop_pod365 cam_icu_pod1 cam_icu_pod2 cam_icu_pod3 cam_icu_pod4 cam_icu_pod5 cam_icu_pod6 cam_icu_pod7 cam_icu_pod8 cam_icu_pod9 cam_icu_pod10 rass_pod1 rass_pod2 rass_pod3 rass_pod4 rass_pod5 rass_pod6 rass_pod7 rass_pod8 rass_pod9 rass_pod10 los_icu los los_surgery_discharge death_inhospital death_date death_pod30 death_pod60 death_pod90 death_pod365 afib_postop afib_postop_datetime afib_hours_between_orouttime_and_afib_postop_datetime afib_postop_ecg stroke_postop ventilation_time
The size of the registry for cardiac surgery patients in currently over 8,000 patients which should be more than enough to demonstrate an effect.
The following is a brief description of the investigators data analysis:
- Categorical variables will be expressed as frequency and percentage.
- Continuous variables will be reported as median and interquartile range (IQR).
- the investigators will compare the prevalence of medication use with the incidence of postoperative delirium and adjust for confounders.
- Analysis will initially be completed with adjusting for confounders, and then consider matching patients with propensity score based on initial results.
- Statistical significance (p≤0.05) for categorical variables will be computed using the Fisher's exact test or chi-squared and the Deuchler-Wilcoxon procedure or t-test for continuous variables.
- An iterative expectation-maximization (EM) algorithm will be considered to account for missing values or other form of imputation method unless deletion of missing data is more ideal.
- Conditions
- Delirium
- Being tested
- Statin, beta blocker, Cardiopulmonary bypass
- Keywords
- Cardiac surgery, Risk factors, Postoperative delirium
- Medical subject headings
- Delirium, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Statin, beta blockerDrug
Also called 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
Patients receiving either statin or beta blockers prior to cardiac surgery.
Cardiopulmonary bypassOther
Patients exposed to cardiopulmonary bypass during cardiac surgery.
| Study group | Role | What they receive |
|---|---|---|
| Delirium | Patients diagnosed with delirium at any time postoperatively with the CAM-ICU. Receives: Drug: Statin, beta blocker; Other: Cardiopulmonary bypass | |
| No delirium | Patients not diagnosed with delirium postoperatively. Receives: Drug: Statin, beta blocker; Other: Cardiopulmonary bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of delirium
CAM-ICU positive at any time after cardiac surgery
Measured: During ICU stay, average may be 4 days
Secondary outcomes (6)
Duration of delirium
Duration of delirium in days with CAM-ICU positive
Measured: During ICU stay, average may be 4 days
In hospital and 30 day mortality
Mortality during hospital admission and within 30 days of surgery
Measured: During hospital admission and within 30 days of surgery
Acute kidney injury
Kidney injury defined using KDIGO AKI staging criteria
Measured: During hospital stay, average may be 1 week
Atrial fibrillation
Atrial fibrillation defined as documentation of atrial fibrillation by bedside nurse in nursing flowsheet
Measured: During hospital stay, average may be 1 week
Total length of stay
Total length of stay defined as difference between admission and discharge dates
Measured: During hospital stay, average may be 1 week
Days in ICU
Days in ICU defined as total days in ICU before floor transfer
Measured: During ICU stay, average may be 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2015 (estimated)
- Study startNov 2009
- Primary completionOct 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5,600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason O'Neal, Vanderbilt University
- Investigators
- Jason O'Neal, M.D., Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02548975
- Sponsor's protocol ID
- 123456789
- Status last verified
- Jul 2026
- First submitted
- 4 Sep 2015
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28718100
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Delirium Following Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02548975
- Acronym / sponsor ID
- 123456789
- Conditions
- Delirium
- Keywords
- Cardiac surgery, Risk factors, Postoperative delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,600 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Oct 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 14 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In order to understand the role of medication usage and/or cardiopulmonary bypass, the investigators propose to leverage the perioperative data warehouse (PDW), an IRB approved data registry, to retrospectively evaluate the subjects. All patient data available in the warehouse may be included in the review. At this time, there are approximately 750,000 patients in the PDW. All data will be accessed retrospectively after the patient has been seen for their care here at Vanderbilt.
The Vanderbilt Perioperative Information Management System (VPIMS) is part of an integrated system that covers the entire perioperative process including instrument \& supply management, scheduling, and status displays. Because of the extensive effort that has been put toward in-house intraoperative software development, the Vanderbilt Anesthesiology \& Perioperative Informatics Research (VAPIR) Division is able to benefit from the availability of thousands of historical intraoperative records, each containing detailed physiologic information. The PDW incorporates VPIMS and electronic healthcare records (EHR) to build its database. In addition to PDW, information from the Society for Thoracic Surgeons (STS) database will be used in our study.
The database uses algorithms created by programmers with the assistance clinicians to screen the data and assess for accuracy and completeness. Once the data is compounded and uploaded, each variable is screened for outliers by a clinician. Outliers will be assessed and validated by a clinician based on trends from the raw data. The data collected for this study includes an extensive data dictionary listed below:
variable teeid anescasenumber mrn date orintime orouttime age gender race hx_dialysis_vpec hx_dialysis_hemodialysis_vpec hx_dialysis_peritoneal_vpec hx_esrd creatinine_base creatinine_pod1 creatinine_pod2 creatinine_pod3 creatinine_pod4 creatinine_pod5 creatinine_pod6 creatinine_pod7 creatinine_pod8 creatinine_pod9 creatinine_pod10 hx_htn hx_mi ck_preop ckmb_preop troponin_preop hx_cabg hx_angioplasty hx_angina hx_chf hx_ef_less_35 hx_chf_recent_hospital hx_chf_stable hx_chf_currentsigns hx_afib hx_aflutter hx_carotid_disease_current hx_carotid_disease_past hx_dementia hx_depression hx_stroke hx_tia hx_claudication chol_base ldl_base hdl_base triglycerides_base hx_copd hx_emphysema hx_smoking_current hx_smoking_quitless3months hx_smoking_quitmore3months hx_osa hx_hypoxia_ra_sat_less92 hx_home_o2 diabetes hba1c charlson_index weight height bmi hct_base hb_base platelet_count_base hx_neoplasm statin_preopyesno clopidogrel_preop aspirin_preop betablocker_preop aceinhibitor_preop diuretic_preop preop_meds ph_intraop_first ph_intraop_last ph_intraop_min ph_intraop_max ph_intraop_median ph_intraop_count po2_intraop_first po2_intraop_last po2_intraop_min po2_intraop_max po2_intraop_median po2_intraop_count lactate_intraop_first lactate_intraop_last lactate_intraop_min lactate_intraop_max lactate_intraop_median lactate_intraop_count ebl_intraop hespan_intraop lr_intraop lr5dex_intraop ns_intraop plasmalyte_intraop input_intraop uop_intraop emergency_surgery procedure_cpt procedure_descriptor cabg_grafts cpb_on_time1 cpb_off_time1 cpb_on_time2 cpb_off_time2 cpb_on_time3 cpb_off_time3 cpb_on_time4 cpb_off_time4 cpb_on_time5 cpb_off_time5 cpb_duration cpb_duration_calculated cbp_recorded_matches_calculated ao_clamp_duration circ_arrest_duration ultrafiltration_volume pump_drugs uop_onpump prbc_intraop_ml prbc_intraop_unit ffp_intraop_ml ffp_intraop_unit platelets_intraop_ml platelets_intraop_unit cryo_intraop_ml cryo_intraop_unit prbc_postop ffp_postop platelets_postop cryo_postop ckmb_pod1 req_reop_24 req_reop_72 is_reop wbc_base wbc_pod1 wbc_pod2 wbc_pod3 wbc_pod4 wbc_pod5 wbc_pod6 wbc_pod7 wbc_pod8 wbc_pod9 wbc_pod10 ph_pod1 ph_pod2 ph_pod3 ph_pod4 ph_pod5 ph_pod6 ph_pod7 ph_pod8 ph_pod9 ph_pod10 lactate_pod1 lactate_pod2 lactate_pod3 lactate_pod4 lactate_pod5 lactate_pod6 lactate_pod7 lactate_pod8 lactate_pod9 lactate_pod10 pfratio_pod1 pfratio_pod2 pfratio_pod3 pfratio_pod4 pfratio_pod5 pfratio_pod6 pfratio_pod7 pfratio_pod8 pfratio_pod9 pfratio_pod10 creatinine_pod30 creatinine_pod60 creatinine_pod90 creatinine_pod365 dialysis_postop_predischarge dialysis_postop_pod30 dialysis_postop_pod60 dialysis_postop_pod90 dialysis_postop_pod365 cam_icu_pod1 cam_icu_pod2 cam_icu_pod3 cam_icu_pod4 cam_icu_pod5 cam_icu_pod6 cam_icu_pod7 cam_icu_pod8 cam_icu_pod9 cam_icu_pod10 rass_pod1 rass_pod2 rass_pod3 rass_pod4 rass_pod5 rass_pod6 rass_pod7 rass_pod8 rass_pod9 rass_pod10 los_icu los los_surgery_discharge death_inhospital death_date death_pod30 death_pod60 death_pod90 death_pod365 afib_postop afib_postop_datetime afib_hours_between_orouttime_and_afib_postop_datetime afib_postop_ecg stroke_postop ventilation_time
The size of the registry for cardiac surgery patients in currently over 8,000 patients which should be more than enough to demonstrate an effect.
The following is a brief description of the investigators data analysis:
- Categorical variables will be expressed as frequency and percentage.
- Continuous variables will be reported as median and interquartile range (IQR).
- the investigators will compare the prevalence of medication use with the incidence of postoperative delirium and adjust for confounders.
- Analysis will initially be completed with adjusting for confounders, and then consider matching patients with propensity score based on initial results.
- Statistical significance (p≤0.05) for categorical variables will be computed using the Fisher's exact test or chi-squared and the Deuchler-Wilcoxon procedure or t-test for continuous variables.
- An iterative expectation-maximization (EM) algorithm will be considered to account for missing values or other form of imputation method unless deletion of missing data is more ideal.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delirium | – | Drug: Statin, beta blocker, Other: Cardiopulmonary bypassPatients diagnosed with delirium at any time postoperatively with the CAM-ICU. |
| No delirium | – | Drug: Statin, beta blocker, Other: Cardiopulmonary bypassPatients not diagnosed with delirium postoperatively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiac surgery patients over 18 years old at Vanderbilt University Medical Center
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (2 listed)
- Emergency cases will be excluded.
- depending on the study - Patients undergoing any valve replacement surgery other than aortic valve
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Statin, beta blockerAlso: 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 clasessPatients receiving either statin or beta blockers prior to cardiac surgery. | Drug | Delirium, No delirium |
| Cardiopulmonary bypassPatients exposed to cardiopulmonary bypass during cardiac surgery. | Other | Delirium, No delirium |
Primary outcome
Incidence of delirium
Time frame: During ICU stay, average may be 4 days
CAM-ICU positive at any time after cardiac surgery
6 secondary outcomes
Duration of delirium
Time frame: During ICU stay, average may be 4 days
In hospital and 30 day mortality
Time frame: During hospital admission and within 30 days of surgery
Acute kidney injury
Time frame: During hospital stay, average may be 1 week
Atrial fibrillation
Time frame: During hospital stay, average may be 1 week
Total length of stay
Time frame: During hospital stay, average may be 1 week
Days in ICU
Time frame: During ICU stay, average may be 4 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Derived from this study: PubMed 28718100O'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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason O'Neal, M.D. principal investigator
Vanderbilt University Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium, run by Vanderbilt University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of delirium (time frame: During ICU stay, average may be 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02548975, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.