NCT04986488

Brief Summary

Delirium is a common problem that occurs after cardiac surgery. The incidence of delirium after cardiac surgery is estimated to be 26-52%, with a significant percentage being hypoactive delirium1-4.Postoperative delirium has been associated with higher hospital costs, longer lengths of hospital stay, increased likelihood of institutionalization, increased risk for dementia, and increased morbidity and mortality.5-7 . The overall purpose of this study was to determine the incidence and perioperative factors that predispose to cause delirium in postoperative cardiac surgery patients in our ICU

Trial Health

87
On Track

Trial Health Score

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

Enrollment
234

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2018

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 2, 2021

Completed
Last Updated

August 2, 2021

Status Verified

July 1, 2021

Enrollment Period

6 months

First QC Date

July 12, 2021

Last Update Submit

July 22, 2021

Conditions

Keywords

delirium;post-cardiac surgery;adults

Outcome Measures

Primary Outcomes (1)

  • incidence and perioperative factors that predispose to cause delirium in postoperative cardiac surgery patients in our ICU

    Incidence and perioperative risk factors that may predispose to delirium after cardiac surgery in our settings

    6 months

Secondary Outcomes (1)

  • ICU stay and mechanical ventilation time

    6 months

Study Arms (2)

Without delirium

With delirium

Eligibility Criteria

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

Patients 18 years old and older of both sexes who are undergoing cardiac surgery in a single centre

You may qualify if:

  • Patients 18 years old and older of both sexes
  • Patients who signed an informed consent
  • Patients scheduled for cardiac surgery with extracorporeal circulation (coronary-artery bypass grafting (CABG), cardiac valve replacement (CVR), combined CABG + CVR, excision of cardiac myxoma)

You may not qualify if:

  • Patients who refused to participate before or after operation;
  • Patients in poor general condition;
  • Patients with preoperative dementia, delirium or illiterate, psychiatric or mental disorder (epilepsy, schizophrenia, depression);
  • Patients who died intraoperatively or within the first 6 hours after the procedure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shahid Gangalal National Heart Center

Kathmandu, 11360, Nepal

Location

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Registrar in cardiac anesthesiology and critical care

Study Record Dates

First Submitted

July 12, 2021

First Posted

August 2, 2021

Study Start

July 1, 2018

Primary Completion

December 30, 2018

Study Completion

December 30, 2018

Last Updated

August 2, 2021

Record last verified: 2021-07

Locations