Cardiac ArrestPhase 4PRESENCENCT01009606
Cardiopulmonary Resuscitation Witnessing by a Relative
A Phase 4 study testing Usual strategy and Modified strategy in people with Cardiac Arrest, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The bereavement generated by the loss of a family member can induce pathological situations: depressive state, anxiety, post-traumatic stress disorder and complicated grief. These morbid factors can be influenced by the death circumstances and in particular by the possibility given to the family to attend the medical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Usual strategy and Modified strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 570 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2009to Dec 2011
- Phase
- Phase 4
- 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
Who may be able to join
- Patient victim of a cardiac arrest and resuscitation initiated
- Occurrence of cardiac arrest at home
- Presence of a relative :
- husband or spouse
- father or mother
- son or daughter
Show all 10Show fewer
- brother or sister
- Patient's age ≥ 18 years
- Relative's age ≥ 18 years
- Consent of the relative to the participation in the study
Who cannot join
- No understanding of the explanations (language problem, important agitation)
- Non-affiliated to social security
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interest for a Relative of Seeing Himself Proposing to Witness Resuscitation of a Family Member Victim of a Cardiac Arrest
The bereavement generated by the loss of a family member can induce pathological situations: depressive state, anxiety, post-traumatic stress disorder and complicated grief. These morbid factors can be influenced by the death circumstances and in particular by the possibility given to the family to attend the medical management of the patient. This clinical trial aims to evaluate the psychological consequences of bereavement on the relatives according to the possibility of witnessing the cardiopulmonary resuscitation of a family member. This possibility lies within the scope of a strategy of global management of the relatives.
Read the detailed description
This clinical trial aims to compare the presence of post-traumatic stress disorder on a relative related to the death of a family member:
Test group: the medical team will propose to the relative to witness the cardiopulmonary resuscitation.
Control group: the medical team will not modify its usual management of care.
- Conditions
- Cardiac Arrest
- Being tested
- Usual strategy, Modified strategy
- Keywords
- Out-of-hospital, Emergency, Cardiac arrest, Post-traumatic stress disorder
- Medical subject headings
- Heart Arrest, Emergencies, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual strategyOther
Usual strategy
Modified strategyOther
Proposition to a relative to witness the cardiopulmonary resuscitation of a family member and debriefing ot the situation
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 : Control : usual strategy | Active comparator | Not described Receives: Other: Usual strategy |
| Arm 2: Comparator : modified strategy | Experimental | Not described Receives: Other: Modified strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of relatives having a score of the Impact of Events Scale (IES) > 30
Measured: 3 months
Secondary outcomes (6)
Psychological questionnaires as the hospital anxiety and depression scale (HAD), the Mini International Neuropsychiatric Interview (MINI), the Inventory of Complicated Grief (ICG)
Measured: 3 and 12 months
Psychological follow-up
Measured: 3 months
Suicide
Measured: 3 and 12 months
Medico-legal recourse
Measured: 12 months
Quality of the cardiopulmonary resuscitation
Measured: day 0
Questionnaire evaluating the stress of the medical and paramedical team
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 570 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Frédéric ADNET, MD,PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01009606
- Sponsor's protocol ID
- P071239
- Acronym
- PRESENCE
- Status last verified
- Dec 2012
- First submitted
- 6 Nov 2009
- Last updated
- 18 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jabre P, Bougouin W, Dumas F, Carli P, Antoine C, Jacob L, Dahan B, Beganton F, Empana JP, Marijon E, Karam N, Loupy A, Lefaucheur C, Jost D, Cariou A, Adnet F, Rea TD, Jouven X. Early Identification of Patients With Out-of-Hospital Cardiac Arrest With No Chance of Survival and Consideration for Organ Donation. Ann Intern Med. 2016 Dec 6;165(11):770-778. doi: 10.7326/M16-0402. Epub 2016 Sep 13.
PubMed 27618681Jabre P, Tazarourte K, Azoulay E, Borron SW, Belpomme V, Jacob L, Bertrand L, Lapostolle F, Combes X, Galinski M, Pinaud V, Destefano C, Normand D, Beltramini A, Assez N, Vivien B, Vicaut E, Adnet F. Offering the opportunity for family to be present during cardiopulmonary resuscitation: 1-year assessment. Intensive Care Med. 2014 Jul;40(7):981-7. doi: 10.1007/s00134-014-3337-1. Epub 2014 May 23.
PubMed 24852952Jabre P, Belpomme V, Azoulay E, Jacob L, Bertrand L, Lapostolle F, Tazarourte K, Bouilleau G, Pinaud V, Broche C, Normand D, Baubet T, Ricard-Hibon A, Istria J, Beltramini A, Alheritiere A, Assez N, Nace L, Vivien B, Turi L, Launay S, Desmaizieres M, Borron SW, Vicaut E, Adnet F. Family presence during cardiopulmonary resuscitation. N Engl J Med. 2013 Mar 14;368(11):1008-18. doi: 10.1056/NEJMoa1203366.
PubMed 23484827
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest for a Relative of Seeing Himself Proposing to Witness Resuscitation of a Family Member Victim of a Cardiac Arrest
- ClinicalTrials.gov ID
- NCT01009606
- Acronym / sponsor ID
- PRESENCE / P071239
- Conditions
- Cardiac Arrest
- Keywords
- Out-of-hospital, Emergency, Cardiac arrest, Post-traumatic stress disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 570 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Nov 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 9 Nov 2009 (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.
The bereavement generated by the loss of a family member can induce pathological situations: depressive state, anxiety, post-traumatic stress disorder and complicated grief. These morbid factors can be influenced by the death circumstances and in particular by the possibility given to the family to attend the medical management of the patient. This clinical trial aims to evaluate the psychological consequences of bereavement on the relatives according to the possibility of witnessing the cardiopulmonary resuscitation of a family member. This possibility lies within the scope of a strategy of global management of the relatives.
Detailed description
This clinical trial aims to compare the presence of post-traumatic stress disorder on a relative related to the death of a family member:
Test group: the medical team will propose to the relative to witness the cardiopulmonary resuscitation.
Control group: the medical team will not modify its usual management of care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 : Control : usual strategy | Active comparator | Other: Usual strategy |
| Arm 2: Comparator : modified strategy | Experimental | Other: Modified strategy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient victim of a cardiac arrest and resuscitation initiated
- Occurrence of cardiac arrest at home
- Presence of a relative :
- Patient's age ≥ 18 years
- Relative's age ≥ 18 years
Key exclusion criteria (2 listed)
- No understanding of the explanations (language problem, important agitation)
- Non-affiliated to social security
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 |
|---|---|---|
| Usual strategyUsual strategy | Other | Arm 1 : Control : usual strategy |
| Modified strategyProposition to a relative to witness the cardiopulmonary resuscitation of a family member and debriefing ot the situation | Other | Arm 2: Comparator : modified strategy |
Primary outcome
Percentage of relatives having a score of the Impact of Events Scale (IES) > 30
Time frame: 3 months
6 secondary outcomes
Psychological questionnaires as the hospital anxiety and depression scale (HAD), the Mini International Neuropsychiatric Interview (MINI), the Inventory of Complicated Grief (ICG)
Time frame: 3 and 12 months
Psychological follow-up
Time frame: 3 months
Suicide
Time frame: 3 and 12 months
Medico-legal recourse
Time frame: 12 months
Quality of the cardiopulmonary resuscitation
Time frame: day 0
Questionnaire evaluating the stress of the medical and paramedical team
Time frame: day 0
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 18 Jan 2013.
- Derived from this study: PubMed 27618681Jabre P, Bougouin W, Dumas F, Carli P, Antoine C, Jacob L, Dahan B, Beganton F, Empana JP, Marijon E, Karam N, Loupy A, Lefaucheur C, Jost D, Cariou A, Adnet F, Rea TD, Jouven X. Early Identification of Patients With Out-of-Hospital Cardiac Arrest With No Chance of Survival and Consideration for Organ Donation. Ann Intern Med. 2016 Dec 6;165(11):770-778. doi: 10.7326/M16-0402. Epub 2016 Sep 13.
- Derived from this study: PubMed 24852952Jabre P, Tazarourte K, Azoulay E, Borron SW, Belpomme V, Jacob L, Bertrand L, Lapostolle F, Combes X, Galinski M, Pinaud V, Destefano C, Normand D, Beltramini A, Assez N, Vivien B, Vicaut E, Adnet F. Offering the opportunity for family to be present during cardiopulmonary resuscitation: 1-year assessment. Intensive Care Med. 2014 Jul;40(7):981-7. doi: 10.1007/s00134-014-3337-1. Epub 2014 May 23.
- Derived from this study: PubMed 23484827Jabre P, Belpomme V, Azoulay E, Jacob L, Bertrand L, Lapostolle F, Tazarourte K, Bouilleau G, Pinaud V, Broche C, Normand D, Baubet T, Ricard-Hibon A, Istria J, Beltramini A, Alheritiere A, Assez N, Nace L, Vivien B, Turi L, Launay S, Desmaizieres M, Borron SW, Vicaut E, Adnet F. Family presence during cardiopulmonary resuscitation. N Engl J Med. 2013 Mar 14;368(11):1008-18. doi: 10.1056/NEJMoa1203366.
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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.
Frédéric ADNET, MD,PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Usual strategy and Modified strategy in people with Cardiac Arrest, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 10 inclusion and 2 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 18 Jan 2013. 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 France. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Percentage of relatives having a score of the Impact of Events Scale (IES) > 30 (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01009606, which also lists 3 linked publications.
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 18 Jan 2013.