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Baden Prevention and Reduction of Incidence of Postoperative Delirium Trial (PRIDe)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02433041
Recruitment Status : Completed
First Posted : May 4, 2015
Last Update Posted : January 23, 2019
Sponsor:
Collaborator:
Kantonsspital Baden
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Tracking Information
First Submitted Date  ICMJE April 7, 2015
First Posted Date  ICMJE May 4, 2015
Last Update Posted Date January 23, 2019
Study Start Date  ICMJE July 2013
Actual Primary Completion Date December 21, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2015)
Differences among study groups - Significant drop in MMSE of two points in one of the three postoperative follow-up days [ Time Frame: 5 day follow-up (preoperative, day of surgery, postoperative days 1-3) ]
Significant drop in MMSE of two points in one of the three postoperative follow-up days (ICU patients excluded)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2015)
Quantification of incidence of postoperative delirium based on cognitive testing and lab parameters [ Time Frame: 5 day follow-up (preoperative, day of surgery, postoperative days 1-3) ]
Drop of one point in Nursing Delirium Screening Scale (Nu-DESC) compared pre- and postoperatively, comparison of levels of NSE, S-100beta and Cortisol (significantly elevated postoperatively?)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Baden Prevention and Reduction of Incidence of Postoperative Delirium Trial
Official Title  ICMJE Baden PRIDe Trial - Baden Prevention and Reduction of Incidence of Postoperative Delirium Trial
Brief Summary The purpose of this study is to find out whether postoperative delirium can be more properly prevented by the combination of determined preventive agents in past studies. Further on the investigators measure pre- and postoperative cortisol, neuron specific enolase (NSE) and S-100beta levels.
Detailed Description The postoperative delirium remains a challenge for medical stuff concerning detection, therapy and avoidance of consequences. Over the years numerous risk factors were detected which emphasizes the importance of its prevention. Within these studies some possibilities, but no strictly defined rules of action for pharmacological or neuropsychological prevention are described. This is why in this randomized, double-blinded, placebo-controlled study, the investigators want to compare two agents that were found to prevent postoperative delirium to a certain level, even in combination: the investigators arrange the patients within four study groups, one receiving Haloperidol, one Ketamine, one both and one placebo. The patients receive the study drug only once right before induction of anesthesia. After the day of recruitment there is the day of operation and a follow-up of three days (5 days of observation in total, where the investigators will test cognitive function with Mini Mental Status Examination (MMSE), Delirium Observation Scale (DOS), Nursing Delirium Screening Scale (Nu-DESC) or Intensive Care Delirium Screening Checklist (ICDSC). Additionally the investigators will measure and compare pre- and postoperative Cortisol, NSE and S-100beta levels.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Postoperative Delirium
Intervention  ICMJE
  • Drug: Haloperidol
    Haloperidol 0.005mg/kg at induction of anesthesia
  • Drug: Ketamine
    Ketamine 1mg/kg at induction of anesthesia to test its power to prevent postoperative delirium
  • Drug: Haloperidol + Ketamine
    Haloperidol 0.005mg/kg + Ketamine 1mg/kg at induction of anesthesia to test their power to prevent postoperative delirium if given together
  • Drug: Saline solution (NaCl 0.9%)
    Placebo being used in one of the four groups
Study Arms  ICMJE
  • Active Comparator: Haloperidol
    Haloperidol 0.005mg/kg at induction of anesthesia
    Intervention: Drug: Haloperidol
  • Active Comparator: Ketamine
    Ketamine 1mg/kg at induction of anesthesia
    Intervention: Drug: Ketamine
  • Active Comparator: Haloperidol + Ketamine
    Combination of Haloperidol + Ketamine in same dosage at induction of anesthesia
    Intervention: Drug: Haloperidol + Ketamine
  • Placebo Comparator: Saline solution (NaCl 0.9%)
    Placebo
    Intervention: Drug: Saline solution (NaCl 0.9%)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 28, 2015)
200
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 21, 2018
Actual Primary Completion Date December 21, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 65 years and older
  • Signed agreement

Exclusion Criteria:

  • Delirium at admittance or MMSE score <24 points
  • High risk for postoperative ICU treatment
  • Haloperidol or Ketamine intolerance
  • Risk of lack of cooperation
  • Drug an alcohol abuse
  • Dementia
  • QT interval (QTc) prolongation (at least 460ms in men, at least 470ms women) or drugs influencing QT interval, such as class Ia and III antiarrhythmics, Gatifloxacin, Moxifloxacin, Pentamidin, Cotrimoxazol, Tacrolimus, Dolasetron
  • Parkinson's disease
  • Intake of dopaminergic drugs (Levodopa, dopamine agonists)
  • Parkinsonism
  • Epilepsy
  • Unable to be interviewed (severe Dementia, speaking disorders, intubation, respiratory isolation, aphasia, coma, terminal illness)
  • Delay of operation of more than 72 hours past hospital admittance
  • Body weight >100kg
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02433041
Other Study ID Numbers  ICMJE 2013DR4089
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Basel, Switzerland
Study Sponsor  ICMJE University Hospital, Basel, Switzerland
Collaborators  ICMJE Kantonsspital Baden
Investigators  ICMJE
Study Director: Alexa Hollinger, MD University Hospital, Basel, Switzerland
PRS Account University Hospital, Basel, Switzerland
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP