NCT00257868

Brief Summary

The purpose of this study is to determine whether Rivastigmine is effective for the prevention of postoperative delirium in patients undergoing cardiac surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

November 22, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 23, 2005

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

July 31, 2007

Status Verified

July 1, 2007

First QC Date

November 22, 2005

Last Update Submit

July 30, 2007

Conditions

Delirium

Outcome Measures

Primary Outcomes (1)

  • Development of postoperative delirium within 7 days after cardiac surgery

Secondary Outcomes (3)

  • Severity of delirium occurring within 7 days after cardiac surgery

  • Length of stay (intensive care and hospital)

  • Amount of drugs used for rescue therapy of delirium

Interventions

Rivastigmine prevention of deliriumDRUG

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients undergoing cardiac surgery with use of extracorporeal circulation
  • Aged 65 or more

You may not qualify if:

  • "redo" procedures
  • anticipated use of succinylcholine during operation
  • contraindications to rivastigmine
  • preoperative mini mental score \< 15

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Luzius A Steiner, MD PhD

    Department of Anaesthesia, University Hospital Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 22, 2005

First Posted

November 23, 2005

Study Start

January 1, 2006

Study Completion

July 1, 2007

Last Updated

July 31, 2007

Record last verified: 2007-07

Locations

CH(1)