DeliriumNCT04986488
INCIDENCE OF Delirium After Cardiac SURGERY Surgery
An observational study of Delirium, run by Shahid Gangalal National Heart Centre at 1 site in Nepal.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium
- How many people
- 234 participants
- Where
- 1 siteNepal
- Study dates
- 1 Jul 2018to 30 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients 18 years old and older of both sexes who are undergoing cardiac surgery in a single centre
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence And Predictors of Delirium After Cardiac Surgery; A Prospective Observational Cohort Study From a Single Tertiary Referral Centre
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
- Conditions
- Delirium
- Keywords
- delirium;post-cardiac surgery;adults
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Without delirium | Not described | |
| With delirium | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (1)
ICU stay and mechanical ventilation time
whetherICU stay in days and mechanical ventilation time in number of hours is affected by delirium
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start1 Jul 2018
- Primary completion30 Dec 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Gangalal National Heart Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Smriti Mahaju Bajracharya,MD, Shahid Gangalal National Heart Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04986488
- Sponsor's protocol ID
- SGNHC 2
- Status last verified
- Jul 2021
- First submitted
- 12 Jul 2021
- Last updated
- 2 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence And Predictors of Delirium After Cardiac Surgery; A Prospective Observational Cohort Study From a Single Tertiary Referral Centre
- ClinicalTrials.gov ID
- NCT04986488
- Acronym / sponsor ID
- SGNHC 2
- Conditions
- Delirium
- Keywords
- delirium;post-cardiac surgery;adults
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Shahid Gangalal National Heart CentreUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 2 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Without delirium | – | – |
| With delirium | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 18 years old and older of both sexes who are undergoing cardiac surgery in a single centre
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
incidence and perioperative factors that predispose to cause delirium in postoperative cardiac surgery patients in our ICU
Time frame: 6 months
Incidence and perioperative risk factors that may predispose to delirium after cardiac surgery in our settings
1 secondary outcome
ICU stay and mechanical ventilation time
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
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Prediction and Prevention of Postoperative Mortality and Morbidity
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The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
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Lactium Premedication to Prevent Emergence Agitation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium, run by Shahid Gangalal National Heart Centre at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence and perioperative factors that predispose to cause delirium in postoperative cardiac surgery patients in our ICU (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2021.