Unexpected Cardiac Arrest in Intensive Care Unit (ACIR)

July 31, 2020 updated by: Groupe Hospitalier de la Rochelle Ré Aunis

Prospective Multi-centre Observational Study on the Epidemiology, Risk Factors and Consequences of Unexpected Cardiac Arrest in Intensive Care Units.

Unexpected cardiac arrest involves approximately 0.5 to 5% of patients admitted in Intensive Care Unit (ICU). Even if they have a technical environment conducive to prompt diagnosis and prompt treatment, patients hospitalized in ICU suffer from chronic illnesses and organ failure(s) that obscure the prognosis of cardiac arrest. Although extra cardiac arrhythmias or intra-hospital arrests are the subject of numerous publications, few studies specifically focus on unexpected cardiac arrest in ICU (none in France). The objective of our work is to produce a prospective epidemiological description of unexpected cardiac arrest in in French ICUs.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Unexpected cardiac arrest in ICU corresponds to cardiovascular arrest leading to at least one cardiopulmonary resuscitation technique (external cardiac massage and / or electric shock). They account for about 0.5 to 5% of admissions to intensive care units. Even if they benefit from a technical environment conducive to prompt diagnosis and rapid management, Resuscitated patients suffer from chronic diseases and organ failure (s) that darken the prognosis. Etiologies of unexpected cardiac arrest in ICU are rarely described in the literature. Their specificity comes from the fact that they can be related to patient's medical characteristics, but also to deleterious effects of supportive techniques in place at the time of circulatory arrest (respiratory assistance, vasopressor drugs, extracorporeal circulation ...). These same techniques may also reduce the effectiveness of cardiopulmonary resuscitation (cardiorespiratory interactions of respiratory assistance, pro-arrhythmogenic effect of vasopressor drugs, haemodynamic repercussion of extracorporeal circulation). Although cardiac arrests have been published extensively out of or in-hospital, there are few studies specifically concerning unexpected cardiac arrest in ICU (none in France). The prognosis is different: after an unexpected cardiac arrest in ICU, 50% of the patients recover a spontaneous cardiac activity but only 15% leave alive from the hospital (3 to 4% with a good functional autonomy). A prospective description of risk factors, circumstances and consequences in the medium term would identify (and prevent) risky situations and identify, among those at risk for unexpected cardiac arrest, those for whom a cardiopulmonary resuscitation is justified.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
677

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Agen, France
        • CH Agen
      • Angers, France
        • CHU Angers
      • Angouleme, France
        • CH Angouleme
      • Arras, France
        • CH Arras
      • Beaumont, France
        • GH Carnelle Portes de l'Oise
      • Bethune, France
        • CH Béthune
      • Blois, France
        • CH Blois
      • Bobigny, France
        • APHP
      • Bourg en Bresse, France
        • Ch Bourg En Bresse
      • Brest, France
        • CHU Brest
      • Caen, France
        • CHU Caen
      • Cahors, France
        • CH Cahors
      • Chartres, France
        • CH Chartres
      • Cholet, France
        • Ch Cholet
      • Colmar, France
        • CH Colmar
      • Dieppe, France
        • Ch Dieppe
      • Dijon, France
        • CHU Dijon
      • Etampes, France
        • CH Sud Essonnes
      • Garches, France
        • APHP
      • Grenoble, France
        • Chu Grenoble
      • Gueret, France
        • CH Guéret
      • La Roche sur Yon, France
        • CHD Vendée
      • La Rochelle, France
        • GH La Rochelle Ré Aunis
      • La Réunion, France
        • CHU La Réunion
      • Lens, France
        • CH Lens
      • Lille, France
        • GH de l'Institut Catholique de Lille
      • Limoges, France
        • CHU Limoges
      • Lyon, France
        • Chu Lyon
      • Meaux, France
        • CH Meaux
      • Melun, France
        • CH Melun
      • Nantes, France
        • CHU Nantes
      • Niort, France
        • CH NIORT
      • Nîmes, France
        • CHU Nîmes
      • Orleans, France
        • CHR Orléans
      • Paris, France
        • APHP Cochin
      • Paris, France
        • Hôpital Paris Saint Joseph
      • Paris, France
        • APHP Saint Louis
      • Pau, France
        • CH Pau
      • Poitiers, France
        • CHU Poitiers
      • Pontoise, France
        • CH Pontoise
      • Quimper, France
        • Ch Cornouaille
      • Roanne, France
        • CH Roanne
      • Rouen, France
        • CHU Rouen
      • Versailles, France
        • CH Versailles

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients admitted in intensive care unit during the study period and presenting an unexpected cardiac arrest will be included

Description

Inclusion Criteria:

  • Patient with unexpected cardiac arrest during his / her hospitalization in the ICU
  • Patients who have benefited from at least one basic cardiopulmonary resuscitation technique by the ICU team to treat this circulatory arrest (external electric shock, external cardiac massage, adrenaline injection ...)
  • Patients with multiple unexpected cardiac arrest during hospitalization will be included only for the first circulatory arrest.

Exclusion Criteria:

  • Patients with unexpected cardiac that have not been resuscitated.
  • Patients in cardiac arrest at admission to ICU

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Patients With Unexpected Cardiac Arrest
Time Frame: 1 year
Number of patients with at least one cardiac arrest in intensive care with attempted cardiopulmonary resuscitation as a proportion of total admissions.
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Patients Per Reason for ICU Admission
Time Frame: 1 year
Number of patients admitted to ICU with either Medical (vs surgical) reason for admission, circulatory failure, respiratory failure, cardiac arrest, cardiac surgery
1 year
History, Comorbidities Before Unexpected Cardiac Arrest
Time Frame: 1 year
High blood pressure, Diabetes, Dyslipidemia, Tobacco, Ischemic heart disease, Heart disease from another cause, Malignancy, Alcohol, Renal disease, Respiratory disease, Cardiac arrest, Neurological disease, Liver disease
1 year
Mc Cabe Score Before Unexpected Cardiac Arrest
Time Frame: 1 year

0- absence of underlying disease or non-life-threatening disease

  1. underlying life-threatening disease over a period of 5 years
  2. underlying disease estimated fatal within 1 year
1 year
Knaus Score Before Unexpected Cardiac Arrest
Time Frame: 1 year
A- No activity limitation B- Moderate restriction of activity (limited professional activities) C- Major activity restriction but not total D- Major activity restriction, bedridden condition, long-term hospitalization
1 year
Organ Failure Score Before Unexpected Cardiac Arrest
Time Frame: 1 year

sequential organ failure assessment (SOFA) sub-score ≥ 3

  • Respiratory failure: < 200 fraction of inspired oxygen inspired oxygen fraction (26.7 mmHg [kilopascal]) and mechanically ventilated,
  • Neurological impairment : Glasgow coma scale <10,
  • Circulatory failure: dopamine > 5 μg/kg/min OR epinephrine ≤ 0.1 μg/kg/min OR norepinephrine ≤ 0.1 μg/kg/min,
  • Hepatic failure: ≥ 6.0-11.9 mg/dl [102-204 μmol/L] Bilirubin,
  • Haematological failure: < 50 Platelets×103/μl,
  • Renal failure: ≥ 3.5-4.9 mg/dl [300-44 0μmol/L] (or < 500 ml/d) Creatinine
1 year
Number of Participants With Unexpected Cardiac Arrest Etiologies
Time Frame: 1 year
1 year
Number of Patients With Resumption of Spontaneous Cardiac Activity After Cardiopulmonary Resuscitation
Time Frame: 1 year
1 year
Cerebral Performance Category Scale at Hospital Discharge
Time Frame: at Hospital Discharge

Cerebral performance category score (CPC)

  1. Conscious without neurological deficit or minor deficit
  2. Conscious with moderate deficit
  3. Conscious with severe deficit
  4. Deep Coma or Vegetative State
  5. Deceased
at Hospital Discharge
Cerebral Performance Category Scale at 6 Months
Time Frame: at 6 months after inclusion (unexpected cardiac arrest)

Cerebral performance category score (CPC)

  1. Conscious without neurological deficit or minor deficit
  2. Conscious with moderate deficit
  3. Conscious with severe deficit
  4. Deep Coma or Vegetative State
  5. Deceased
at 6 months after inclusion (unexpected cardiac arrest)
Number of Patients With Unexpected Cardiac Arrest, Resuscitated Despite Previous Decision Not to Resuscitate
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Groupe Hospitalier de la Rochelle Ré Aunis

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Maxime Leloup, MD, Groupe Hospitalier de La Rochelle Ré Aunis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2017

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 16, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2015/P04/049

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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