4006-776-356 出国就医服务电话

免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Assessing the Incidence of Postoperative Delirium Following Aortic Valve Replacement (IPOD-AV)

Assessing the Incidence of Postoperative Delirium Following Aortic Valve Replacement (IPOD-AV)

Study Description
Brief Summary:
Our primary aim in this observational study is to identify the incidence of POD in the first five postoperative days by using the 3-minute Diagnostic confusion assessment method (3D-CAM), the derived version for intensive care unit (CAM-ICU) or nurse reports in patients undergoing different techniques of aortic valve replacement. Patients are followed 5 days postoperative with the 3D-CAM or until resolution of POD. Six months postoperatively, a follow-up by phone is planned for activity of daily living (ADL).

Condition or disease
Postoperative Delirium Aortic Valve Stenosis

Detailed Description:
A significant and often underrecognized complication after surgery is postoperative delirium (POD) causing increased morbidity and mortality. This is especially true for the older cardiac surgical patient, in whom the incidence of POD is up to 70%. Surgical invasiveness and herewith related inflammation, a cholinergic load of medications, postoperative pain or use of opioids are examples of precipitating factors that can be altered to reduce the incidence of POD. Transaortic valve replacement (TAVR) is a revolutionary technique that has led to a dramatic decrease in surgical invasiveness and improved outcomes in high-risk surgical patients. However, only a few studies evaluated neurocognitive outcome after surgical aortic valve replacement (SAVR) compared to TAVR, suggesting a reduced incidence of POD with TAVR compared to SAVR. In contrast, other studies found almost no difference in POD in the aforementioned patient groups. Hence, it remains still unclear which technique best to use in patients at high risk for POD.
Study Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessing the Incidence of Postoperative Delirium Following Aortic Valve Surgery
Actual Study Start Date : September 23, 2018
Actual Primary Completion Date : January 20, 2020
Actual Study Completion Date : July 9, 2020
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Incidence of postoperative delirium [ Time Frame: During the first five postoperative days or until discharge, in case of POD followup until resolution of POD or discharge. ]
    Using the 3-minute Diagnostic confusion assessment method (3D-CAM), the derived version for intensive care unit (CAM-ICU) or nurse reports combined with interview with the caregivers and patient


Secondary Outcome Measures :
  1. Onset postoperative delirium [ Time Frame: During the first five postoperative days or discharge ]
    Moment of onset of POD

  2. Duration of POD [ Time Frame: If POD develops during the first 5 postoperative days, patient will be followed until POD has resolved or until discharge ]
    Duration of delirium in days using the 3D-CAM or ICU-CAM

  3. Severity of POD [ Time Frame: If POD develops during the first 5 postoperative days, patient will be followed until POD has resolved or until discharge ]
    assessed with the delirium severity measure-based CAM (CAM-S Long)

  4. Early safety according to VARC-2 [ Time Frame: 30 days ]
    Early safety (at 30 days) defined by the Valve Academic Research Consortium (VARC)-2

  5. Clinical efficacy according to VARC-2 [ Time Frame: 6 months ]
    Clinical efficacy (at 6 months) as defined by VARC-2


Other Outcome Measures:
  1. Intensive care unit (ICU) length of stay [ Time Frame: 30 days ]
    Intensive care unit (ICU) length of stay

  2. Hospital length of stay [ Time Frame: 30 days ]
    Amount of days hospitalized in the primary center

  3. Discharge destination [ Time Frame: 30 days ]
    Discharge destination defined as: home, nursing home, revalidation unit or other hospital.

  4. 6-months interview [ Time Frame: 6 months ]
    Assessment of different questionnaires: self-administered instrumental activities of daily living, 5 dimensional quality of life (EQ-5D-5L), visual analoge scale for quality of life (EQ-VAS) and cognitive failure questionnaire.


Biospecimen Retention:   Samples Without DNA
presence of neural injury markers

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Any patient presenting for the indicated surgery in a tertiary university hospital
Criteria

Inclusion Criteria:

  • Patients scheduled to undergo elective

    • TAVI
    • SAVR (with or without coronary artery bypass grafting (CABG) or pulmonary vein isolation (PVI))
  • Patient able to read and understand the research materials

Exclusion Criteria:

  • Inability to give informed consent
  • Presence of delirium at baseline as screened with the 3-minute Diagnostic Confusion Assessment Method (3D-CAM)
  • Combined surgical procedures (e.g. mitral valve surgery, aortic surgery or other)
Contacts and Locations

Locations
Layout table for location information
Belgium
University Hospitals Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Layout table for investigator information
Principal Investigator: Danny Hoogma, MD Universitaire Ziekenhuizen Leuven
Tracking Information
First Submitted Date May 8, 2019
First Posted Date May 15, 2019
Last Update Posted Date January 19, 2021
Actual Study Start Date September 23, 2018
Actual Primary Completion Date January 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 13, 2021) 		Incidence of postoperative delirium [ Time Frame: During the first five postoperative days or until discharge, in case of POD followup until resolution of POD or discharge. ]
Using the 3-minute Diagnostic confusion assessment method (3D-CAM), the derived version for intensive care unit (CAM-ICU) or nurse reports combined with interview with the caregivers and patient
Original Primary Outcome Measures
 (submitted: May 10, 2019) 		Incidence of postoperative delirium [ Time Frame: During the first five postoperative days or until discharge, in case of POD followup until resolution of POD or discharge. ]
Using the 3-minute Diagnostic confusion assessment method (3D-CAM) or the derived version for intensive care unit (CAM-ICU)
Change History
Current Secondary Outcome Measures
 (submitted: January 13, 2021)
  • Onset postoperative delirium [ Time Frame: During the first five postoperative days or discharge ]
    Moment of onset of POD
  • Duration of POD [ Time Frame: If POD develops during the first 5 postoperative days, patient will be followed until POD has resolved or until discharge ]
    Duration of delirium in days using the 3D-CAM or ICU-CAM
  • Severity of POD [ Time Frame: If POD develops during the first 5 postoperative days, patient will be followed until POD has resolved or until discharge ]
    assessed with the delirium severity measure-based CAM (CAM-S Long)
  • Early safety according to VARC-2 [ Time Frame: 30 days ]
    Early safety (at 30 days) defined by the Valve Academic Research Consortium (VARC)-2
  • Clinical efficacy according to VARC-2 [ Time Frame: 6 months ]
    Clinical efficacy (at 6 months) as defined by VARC-2
Original Secondary Outcome Measures
 (submitted: May 10, 2019)
  • Onset postoperative delirium [ Time Frame: During the first five postoperative days or discharge ]
    Moment of onset of POD
  • Duration of POD [ Time Frame: If POD develops during the first 5 postoperative days, patient will be followed until POD has resolved or until discharge ]
    Duration of delirium in days using the 3D-CAM or ICU-CAM
  • Severity of POD [ Time Frame: If POD develops during the first 5 postoperative days, patient will be followed until POD has resolved or until discharge ]
    assessed with the delirium severity measure-based CAM (CAM-S Long)
  • Incidence of subsyndromal delirium [ Time Frame: During the first five postoperative days or discharge ]
    assessed with the delirium severity measure-based CAM (CAM-S Long)
  • Early safety according to VARC-2 [ Time Frame: 30 days ]
    Early safety (at 30 days) defined by the Valve Academic Research Consortium (VARC)-2
  • Clinical efficacy according to VARC-2 [ Time Frame: 6 months ]
    Clinical efficacy (at 6 months) as defined by VARC-2
Current Other Pre-specified Outcome Measures
 (submitted: May 10, 2019)
  • Intensive care unit (ICU) length of stay [ Time Frame: 30 days ]
    Intensive care unit (ICU) length of stay
  • Hospital length of stay [ Time Frame: 30 days ]
    Amount of days hospitalized in the primary center
  • Discharge destination [ Time Frame: 30 days ]
    Discharge destination defined as: home, nursing home, revalidation unit or other hospital.
  • 6-months interview [ Time Frame: 6 months ]
    Assessment of different questionnaires: self-administered instrumental activities of daily living, 5 dimensional quality of life (EQ-5D-5L), visual analoge scale for quality of life (EQ-VAS) and cognitive failure questionnaire.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Assessing the Incidence of Postoperative Delirium Following Aortic Valve Replacement
Official Title Assessing the Incidence of Postoperative Delirium Following Aortic Valve Surgery
Brief Summary Our primary aim in this observational study is to identify the incidence of POD in the first five postoperative days by using the 3-minute Diagnostic confusion assessment method (3D-CAM), the derived version for intensive care unit (CAM-ICU) or nurse reports in patients undergoing different techniques of aortic valve replacement. Patients are followed 5 days postoperative with the 3D-CAM or until resolution of POD. Six months postoperatively, a follow-up by phone is planned for activity of daily living (ADL).
Detailed Description A significant and often underrecognized complication after surgery is postoperative delirium (POD) causing increased morbidity and mortality. This is especially true for the older cardiac surgical patient, in whom the incidence of POD is up to 70%. Surgical invasiveness and herewith related inflammation, a cholinergic load of medications, postoperative pain or use of opioids are examples of precipitating factors that can be altered to reduce the incidence of POD. Transaortic valve replacement (TAVR) is a revolutionary technique that has led to a dramatic decrease in surgical invasiveness and improved outcomes in high-risk surgical patients. However, only a few studies evaluated neurocognitive outcome after surgical aortic valve replacement (SAVR) compared to TAVR, suggesting a reduced incidence of POD with TAVR compared to SAVR. In contrast, other studies found almost no difference in POD in the aforementioned patient groups. Hence, it remains still unclear which technique best to use in patients at high risk for POD.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
presence of neural injury markers
Sampling Method Probability Sample
Study Population Any patient presenting for the indicated surgery in a tertiary university hospital
Condition
  • Postoperative Delirium
  • Aortic Valve Stenosis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 10, 2019) 		250
Original Estimated Enrollment Same as current
Actual Study Completion Date July 9, 2020
Actual Primary Completion Date January 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients scheduled to undergo elective

    • TAVI
    • SAVR (with or without coronary artery bypass grafting (CABG) or pulmonary vein isolation (PVI))
  • Patient able to read and understand the research materials

Exclusion Criteria:

  • Inability to give informed consent
  • Presence of delirium at baseline as screened with the 3-minute Diagnostic Confusion Assessment Method (3D-CAM)
  • Combined surgical procedures (e.g. mitral valve surgery, aortic surgery or other)
Sex/Gender
Sexes Eligible for Study: All
Ages 70 Years and older   (Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium
Removed Location Countries  
 
Administrative Information
NCT Number NCT03950440
Other Study ID Numbers S61710
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party dr. Danny Hoogma, Universitaire Ziekenhuizen Leuven
Study Sponsor Universitaire Ziekenhuizen Leuven
Collaborators Not Provided
Investigators
Principal Investigator: Danny Hoogma, MD Universitaire Ziekenhuizen Leuven
PRS Account Universitaire Ziekenhuizen Leuven
Verification Date January 2021

治疗医院

新药特效药

前沿医讯