ClinicalTrials.gov

History of Changes for Study: NCT02433041
Baden Prevention and Reduction of Incidence of Postoperative Delirium Trial (PRIDe)
Latest version (submitted January 21, 2019) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 April 28, 2015 None (earliest Version on record)
2 October 28, 2015 Study Status
3 May 2, 2016 Study Status
4 November 2, 2016 Study Status
5 January 11, 2017 Study Status
6 January 8, 2018 Study Status
7 January 21, 2019 Recruitment Status, Study Status, Contacts/Locations and Study Design
Comparison Format:

Scroll up to access the controls

Study NCT02433041
Submitted Date:  April 28, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: 2013DR4089
Brief Title: Baden Prevention and Reduction of Incidence of Postoperative Delirium Trial (PRIDe)
Official Title: Baden PRIDe Trial - Baden Prevention and Reduction of Incidence of Postoperative Delirium Trial
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2015
Overall Status: Recruiting
Study Start: July 2013
Primary Completion: December 2016 [Anticipated]
Study Completion: December 2016 [Anticipated]
First Submitted: April 7, 2015
First Submitted that
Met QC Criteria:
April 28, 2015
First Posted: May 4, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
April 28, 2015
Last Update Posted: May 4, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: University Hospital, Basel, Switzerland
Responsible Party: Sponsor
Collaborators: Kantonsspital Baden
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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.
Open or close this module Conditions
Conditions: Postoperative Delirium
Keywords: Postoperative delirium
Cortisol
NSE
S-100beta
MMSE
Nu-DESC
ICDSC
DOS
Haloperidol
Ketamine
Combination of Haloperidol and Ketamine
Placebo
Prevention of
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 4
Interventional Study Model: Single Group Assignment
Number of Arms: 4
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 200 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: Haloperidol
Haloperidol 0.005mg/kg at induction of anesthesia
Drug: Haloperidol
Haloperidol 0.005mg/kg at induction of anesthesia
Active Comparator: Ketamine
Ketamine 1mg/kg at induction of anesthesia
Drug: Ketamine
Ketamine 1mg/kg at induction of anesthesia to test its power to prevent postoperative delirium
Active Comparator: Haloperidol + Ketamine
Combination of Haloperidol + Ketamine in same dosage at induction of anesthesia
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
Placebo Comparator: Saline solution (NaCl 0.9%)
Placebo
Drug: Saline solution (NaCl 0.9%)
Placebo being used in one of the four groups
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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)
Secondary Outcome Measures:
1. 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?)
Open or close this module Eligibility
Minimum Age: 65 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

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
Open or close this module Contacts/Locations
Central Contact Person: Martin Siegemund, MD
Telephone: +41613286414
Email: martin.siegemund@usb.ch
Central Contact Backup: Alexa Hollinger, MD
Telephone: +41613286508
Email: alexa.hollinger@usb.ch
Study Officials: Alexa Hollinger, MD
Study Director
University Hospital, Basel, Switzerland
Locations: Switzerland
University Hospital Basel
[Recruiting]
Basel, Switzerland, 4031
Contact:Contact: Martin Siegemund, MD +41613286414 martin.siegemund@usb.ch
Contact:Contact: Alexa Hollinger, MD +41613286508 alexa.hollinger@usb.ch
Contact:Sub-Investigator: Harriet Riegger
Contact:Sub-Investigator: Katharina Toft
Contact:Sub-Investigator: Leonie Faller
Contact:Sub-Investigator: Philipp Ruland, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services