Cardiac DiseaseNCT02954861
A Study to Identify the Incidence of Post Traumatic Stress Symptoms in Patients With Delirium Following Cardiac Surgery
An observational study of Cardiac Disease and Delirium, run by University of Edinburgh.
Trial summary
'Post perfusion syndrome' was a term historically associated to cardiac surgery in view of the transient neuro-cognitive deficits attributed to cardio pulmonary bypass pump. During their recovery period, a significant number of patients experience delirium, a clinical syndrome of acute onset and fluctuant… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Disease, Delirium, Stress Disorders, Post-Traumatic
- How many people
- 406 participants
- Where
- No sites listed yet
- Study dates
- 7 Apr 2016to 10 May 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: Following discussion with statisticians and viewing the sample sizes of previous related studies, it was suggested that minimum 200 patients will be required for phase I. This was based on the availability of data in a similar aspects of the study. But incidentally there has been no known study looking specifically at delirium and post traumatic stress symptoms in cardiac surgery patients. So the researcher aims to enrol at least 400 patients but may not be able to achieve this number by the end of data collection phase. Phase II will only have patients who develop delirium and convenient sampling will be applied for the interview section.
Who may be able to join
- Male or female participants age 18 and over.
- Adults with capacity to informed consent
- Elective and urgent conventional cardiac surgery.
Who cannot join
- Patients from the highlands and islands who may not wish to return to the 6 weeks follow up clinic
- Re-do Cardiac surgery
- Emergency Cardiac surgery.
About this study
'Post perfusion syndrome' was a term historically associated to cardiac surgery in view of the transient neuro-cognitive deficits attributed to cardio pulmonary bypass pump. During their recovery period, a significant number of patients experience delirium, a clinical syndrome of acute onset and fluctuant course.Though these deficits are often known to be transient without any permanent physical or neurological impairment, the experience can still psycho-socially affect these patients for a longer length of time even after discharge. The presence of delirium puts excessive, undesired strain on the patient, their families, health care providers and hospital resources.
PTSS is an anxiety disorder caused by very stressful, frightening or distressing events. It is known to either develop immediately after the disturbing event or weeks and months later. The actual symptoms can be varied but are categorized in three sections: i.e.: re-experiencing, avoidance and emotional numbing and hyperarousal (feeling 'on edge').
A problem that has such an impact on any patient is worth investigating and understood better. Being in such a unique professional position, as a Clinical nurse practitioner, the investigator is ideally placed to conduct this study. In this study, the researcher will be focusing on the pre-operative risk factors in developing delirium, actual incidence of delirium and follow the patients post operatively to evaluate the after effects of delirium in the form of PTSS.
Read the detailed description
Delirium is acute onset of fluctuant cognitive state. Post operative delirium is a historically known complication after cardiac surgery. In 2013, almost 900 heart operations were performed in a South East, Scottish Cardio Thoracic unit. and audit data shows that 45% of these patients developed post operative delirium.
Multiple pre, post \& intra operative factors have been attributed to the development of delirium. Whatever the precipitating factors, delirium not only causes psychological distress to the patient but also their loved ones. In some cases this psychological upset continues to affect the patient even after discharge from the hospital referred to as post traumatic stress symptoms (PTSS). This study therefore aims to look at the extent and experience of post operative delirium in cardiac surgery patients.
The study plans to recruit patients at a pre admission clinic where patient's baseline clinical data will be collected. They will also be provided with questionnaires to complete before the end of the clinic. This is to evaluate the participant's pre operative mood, cognitive status and social orientation. During their hospital stay following surgery the participants will be assessed routinely for delirium. If they are known to have suffered from delirium, they will be enrolled to phase 2 of the study.
The consented patients will be seen at 6 week follow up clinic where they will be provided with a questionnaire to identify PTSS and also participate in a semi structured interview. Three months later the same will be repeated on telephone.
Data analysis will help understand and explore this unfortunate patient experience.
- Conditions
- Cardiac Disease, Delirium, Stress Disorders, Post-Traumatic
- Being tested
- No intervention
- Medical subject headings
- Heart Diseases, Delirium, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Cardiac surgery | Patients who develop delirium following cardiac surgery Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
What factors during the peri-operative period in patients with delirium are associated with higher incidence of post traumatic stress symptoms?
Measured: 6 weeks and 3 months following delirium post cardiac surgery
Secondary outcomes (2)
What are the peri-operative factors that are associated with change in PTSS score from 6 weeks to 3 months.
Measured: 6-12 weeks
What are the pre operative features that predict post operative delirium
The pre operative data collected will form an entry baseline for the study. But this will also aid in identifying common factors that are noted in patients who develop post operative delirium.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2016 (estimated)
- Study start7 Apr 2016
- Primary completion30 Mar 2018
- Study completion10 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- 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
- 406 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02954861
- Sponsor's protocol ID
- 172976
- Status last verified
- May 2024
- First submitted
- 8 Sep 2016
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Identify the Incidence of Post Traumatic Stress Symptoms in Patients With Delirium Following Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02954861
- Acronym / sponsor ID
- 172976
- Conditions
- Cardiac Disease, Delirium, Stress Disorders, Post-Traumatic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 406 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian
- Study start
- 7 Apr 2016 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 10 May 2018 (actual)
- First posted
- 4 Nov 2016 (estimated)
- 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.
'Post perfusion syndrome' was a term historically associated to cardiac surgery in view of the transient neuro-cognitive deficits attributed to cardio pulmonary bypass pump. During their recovery period, a significant number of patients experience delirium, a clinical syndrome of acute onset and fluctuant course.Though these deficits are often known to be transient without any permanent physical or neurological impairment, the experience can still psycho-socially affect these patients for a longer length of time even after discharge. The presence of delirium puts excessive, undesired strain on the patient, their families, health care providers and hospital resources.
PTSS is an anxiety disorder caused by very stressful, frightening or distressing events. It is known to either develop immediately after the disturbing event or weeks and months later. The actual symptoms can be varied but are categorized in three sections: i.e.: re-experiencing, avoidance and emotional numbing and hyperarousal (feeling 'on edge').
A problem that has such an impact on any patient is worth investigating and understood better. Being in such a unique professional position, as a Clinical nurse practitioner, the investigator is ideally placed to conduct this study. In this study, the researcher will be focusing on the pre-operative risk factors in developing delirium, actual incidence of delirium and follow the patients post operatively to evaluate the after effects of delirium in the form of PTSS.
Detailed description
Delirium is acute onset of fluctuant cognitive state. Post operative delirium is a historically known complication after cardiac surgery. In 2013, almost 900 heart operations were performed in a South East, Scottish Cardio Thoracic unit. and audit data shows that 45% of these patients developed post operative delirium.
Multiple pre, post \& intra operative factors have been attributed to the development of delirium. Whatever the precipitating factors, delirium not only causes psychological distress to the patient but also their loved ones. In some cases this psychological upset continues to affect the patient even after discharge from the hospital referred to as post traumatic stress symptoms (PTSS). This study therefore aims to look at the extent and experience of post operative delirium in cardiac surgery patients.
The study plans to recruit patients at a pre admission clinic where patient's baseline clinical data will be collected. They will also be provided with questionnaires to complete before the end of the clinic. This is to evaluate the participant's pre operative mood, cognitive status and social orientation. During their hospital stay following surgery the participants will be assessed routinely for delirium. If they are known to have suffered from delirium, they will be enrolled to phase 2 of the study.
The consented patients will be seen at 6 week follow up clinic where they will be provided with a questionnaire to identify PTSS and also participate in a semi structured interview. Three months later the same will be repeated on telephone.
Data analysis will help understand and explore this unfortunate patient experience.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac surgery | – | Other: No interventionPatients who develop delirium following cardiac surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Following discussion with statisticians and viewing the sample sizes of previous related studies, it was suggested that minimum 200 patients will be required for phase I. This was based on the availability of data in a similar aspects of the study. But incidentally there has been no known study looking specifically at delirium and post traumatic stress symptoms in cardiac surgery patients. So the researcher aims to enrol at least 400 patients but may not be able to achieve this number by the end of data collection phase. Phase II will only have patients who develop delirium and convenient sampling will be applied for the interview section.
Key inclusion criteria (3 listed)
- Male or female participants age 18 and over.
- Adults with capacity to informed consent
- Elective and urgent conventional cardiac surgery.
Key exclusion criteria (3 listed)
- Patients from the highlands and islands who may not wish to return to the 6 weeks follow up clinic
- Re-do Cardiac surgery
- Emergency Cardiac surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Cardiac surgery |
Primary outcome
What factors during the peri-operative period in patients with delirium are associated with higher incidence of post traumatic stress symptoms?
Time frame: 6 weeks and 3 months following delirium post cardiac surgery
2 secondary outcomes
What are the peri-operative factors that are associated with change in PTSS score from 6 weeks to 3 months.
Time frame: 6-12 weeks
What are the pre operative features that predict post operative delirium
Time frame: 5 days
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 8 May 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Disease and Delirium, run by University of Edinburgh.
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 3 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 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
What factors during the peri-operative period in patients with delirium are associated with higher incidence of post traumatic stress symptoms? (time frame: 6 weeks and 3 months following delirium post cardiac surgery). 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 8 May 2024.