NCT03246165

Brief Summary

The objective of this research was to determine the incidence, predisposing and triggering factors of delirium following cardiac surgery and its consequences within 30 days of surgery and during a 12-18-month follow-up in older adult patients.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
173

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2011

Longer than P75 for all trials

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

September 1, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2013

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2015

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

August 7, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 11, 2017

Completed
Last Updated

March 26, 2019

Status Verified

March 1, 2019

Enrollment Period

2.3 years

First QC Date

August 7, 2017

Last Update Submit

March 23, 2019

Conditions

DeliriumSurgery--ComplicationsAge Problem

Outcome Measures

Primary Outcomes (1)

  • Delirium

    Delirium was assessed using the Confusion Assessment Method for the Intensive Care Unit

    Until hospital discharge or 30 days after surgery, and for up to 18 months.

Interventions

Cardiac surgeryPROCEDURE

Coronary bypass, heart valve replacement

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients submitted to perioperative evaluation for elective cardiac surgery at the hospital de Messejana in Fortaleza, Ceara.

You may qualify if:

  • Elective cardiovascular surgery

You may not qualify if:

  • Blindness,
  • deafness,
  • previous stroke
  • dementia
  • creatinine clearance \< 30 ml/min
  • emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Delirium

Interventions

Cardiac Surgical Procedures

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Cardiology

Study Record Dates

First Submitted

August 7, 2017

First Posted

August 11, 2017

Study Start

September 1, 2011

Primary Completion

December 30, 2013

Study Completion

June 30, 2015

Last Updated

March 26, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share