NCT02743689

Brief Summary

The aim of the study is to identify the incidence of early postoperative delirium in intensive care patients after cardiac surgery and detect possible risk factors associated with increased risk for developing delirium after cardiac surgery.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
191

participants targeted

Target at P50-P75 for all trials

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

Study Start

First participant enrolled

March 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 13, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 19, 2016

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Last Updated

November 1, 2016

Status Verified

October 1, 2016

Enrollment Period

1.2 years

First QC Date

April 13, 2016

Last Update Submit

October 30, 2016

Conditions

Delirium

Keywords

PostoperativeCardiac surgery

Outcome Measures

Primary Outcomes (1)

  • Incidence of early postoperative delirium in intensive care patients after cardiac surgery

    Within 5 days after the surgery

Secondary Outcomes (1)

  • Perioperative risk factors for delirium after cardiac surgery

    Up to 5 postoperative days or occurence of delirium if it develops earlier

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All consecutive patients scheduled for elective cardiac surgery

You may qualify if:

  • elective cardiac surgery
  • patient spends more than 1 day in the intensive care unit after the surgery

You may not qualify if:

  • refusal to participating in the study
  • documented severe central nervous system, cognitive or psychiatric disorder
  • unable to be screened with Intensive Care Delirium Screening Checklist up to 6th postoperative day (e.g. deeply sedated, intubated patients)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vilnius University Hospital Santariskiu Clinics

Vilnius, 08661, Lithuania

Location

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

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

Study Officials

  • Vilma Kuzminskaite, MD

    Vilnius University Hospital Santariskiu Clinics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 13, 2016

First Posted

April 19, 2016

Study Start

March 1, 2015

Primary Completion

May 1, 2016

Last Updated

November 1, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

LI(1)