Out-of-Hospital Cardiac ArrestNCT02648061
Transitions Between Clinical Circulatory States After Out-of-hospital Cardiac Arrest
An observational study of Out-of-Hospital Cardiac Arrest, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
Extensive research exists for cardio-pulmonary resuscitation (CPR) and the chance of successful return of spontaneous circulation (ROSC) is improved. Unfortunately, the overall prognosis after ROSC has not improved much and the in-hospital mortality is still reported to be 50 to 70 %. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Out-of-Hospital Cardiac Arrest
- How many people
- 50 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2016to 31 Dec 2017
- 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: All adult patients who are admitted to either the Intensive Care Unit (ICU) or the Coronary Care Unit (CCU) at St. Olav's University Hospital, Trondheim, Norway, after out-of-hospital cardiac arrest will be considered for inclusion.(catchment population of 700,000)
Who may be able to join
- Return of spontaneous circulation (ROSC) after out-of-hospital cardiac arrest (OHCA)
- Admitted to Coronary Care Unit (CCU) or Intensive Care Unit (ICU), St. Olav's University Hospital
Who cannot join
- Sepsis within 24 hours before cardiac arrest
- Pregnancy
- Decision of withdrawal or withholding of life prolonging therapy (i.e. due to advanced malignancy)
Trial locations and contacts
1 site in 1 country.
About this study
Extensive research exists for cardio-pulmonary resuscitation (CPR) and the chance of successful return of spontaneous circulation (ROSC) is improved. Unfortunately, the overall prognosis after ROSC has not improved much and the in-hospital mortality is still reported to be 50 to 70 %. The "post-resuscitation disease" is now called the "post-cardiac arrest syndrome" (PCAS) and comprises 1) brain injury, 2) myocardial dysfunction and 3) systemic ischemia and reperfusion.
Treatment of patients after cardiac arrest has often followed guidelines that were primarily developed for treatment of septic shock. It is still uncertain whether this is the optimal way to deliver circulatory support after cardiac arrest.
Read more
There is a lack of studies assessing the relationship between the inflammatory response measured by inflammatory biomarkers and circulatory failure in PCAS.
In this study a detailed description will be given of the clinical trajectory of the circulation and the inflammatory response during the first 5 days after cardiac arrest, and it will be investigated whether patterns of circulatory and inflammatory response may be predictive of deterioration of clinical state.
Read the detailed description
This study will obtain longitudinally advanced hemodynamic observations with high resolution during the acute phase of post cardiac arrest syndrome (PCAS), and analyze the details in clinical transitions related to circulatory failure. The study will also analyze the relationship between inflammatory biomarkers and circulatory failure in PCAS and kinetics of hemodynamics associated with standard interventions in the intensive care unit (ICU).
- Conditions
- Out-of-Hospital Cardiac Arrest
- Keywords
- Blood circulation, Follow-up studies, Biological markers, Hemodynamics
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
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 |
|---|---|---|
| After cardiac arrest syndrome (ACAS) | adult patients after out-of-hospital cardiac arrest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in clinical circulatory state (stable, unstable, severe unstable)
These clinical circulatory states are defined as follows: 1) Stable circulation (Mean blood pressure > 65 mmHg, heart rate 51-100, lactate serum concentrations < 2 mmol/l, ScvO2 > 65, fluid administration < 0.5 l/h, norepinephrine dose < 0.1 microgram/kg/min, no other vasoactive drugs.
- Unstable circulation (mean blood pressure 45-64 mmHg , heart rate 41-50, 101-130, lactate serum concentrations 2-4 mmol/l, ScvO2 > 50-64, fluid administration 0.5-1,9 l/h, norepinephrine dose 0.1-0.29 microgram/kg/min, Dobutamin > 10 microgram/kg/min, no other vasoactive drugs) 3) Severe unstable circulation (mean blood pressure < 45 mmHg , heart rate < 40, > 130, lactate serum concentrations >4 mmol/l, ScvO2 < 50, fluid administration > 2.0 l/h, norepinephrine dose 0.3 or above microgram/kg/min, dobutamin > 10 microgram/kg/min, other vasoactive drugs, use of aortic balloon pump).
Measured: 5 days
Secondary outcomes (1)
Interleukin-6 in relation to dose of Norepinephrine used to correct vasoplegia after cardiac arrest
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 posted6 Jan 2016 (estimated)
- Study startJan 2016
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Out-of-Hospital Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Toril Hernes, prof, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02648061
- Sponsor's protocol ID
- 2015/1807
- Status last verified
- Jan 2022
- First submitted
- 4 Dec 2015
- Last updated
- 4 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Langeland H, Bergum D, Loberg M, Bjornstad K, Damas JK, Mollnes TE, Skjaervold NK, Klepstad P. Transitions Between Circulatory States After Out-of-Hospital Cardiac Arrest: Protocol for an Observational, Prospective Cohort Study. JMIR Res Protoc. 2018 Jan 19;7(1):e17. doi: 10.2196/resprot.8558.
PubMed 29351897Langeland H, Bergum D, Nordseth T, Loberg M, Skaug T, Bjornstad K, Gundersen O, Skjaervold NK, Klepstad P. Circulatory trajectories after out-of-hospital cardiac arrest: a prospective cohort study. BMC Anesthesiol. 2021 Sep 8;21(1):219. doi: 10.1186/s12871-021-01434-2.
PubMed 34496748Langeland H, Damas JK, Mollnes TE, Ludviksen JK, Ueland T, Michelsen AE, Loberg M, Bergum D, Nordseth T, Skjaervold NK, Klepstad P. The inflammatory response is related to circulatory failure after out-of-hospital cardiac arrest: A prospective cohort study. Resuscitation. 2022 Jan;170:115-125. doi: 10.1016/j.resuscitation.2021.11.026. Epub 2021 Nov 24.
PubMed 34838662Farbu BH, Lydersen S, Mohus RM, Ueland T, Mollnes TE, Klepstad P, Langeland H. The detrimental effects of intestinal injury mediated by inflammation are limited in cardiac arrest patients: A prospective cohort study. Resusc Plus. 2024 Apr 17;18:100639. doi: 10.1016/j.resplu.2024.100639. eCollection 2024 Jun.
PubMed 38666252Hoftun Farbu B, Langeland H, Ueland T, Michelsen AE, Jorstad Kruger A, Klepstad P, Nordseth T. Intestinal injury in cardiac arrest is associated with multiple organ dysfunction: A prospective cohort study. Resuscitation. 2023 Apr;185:109748. doi: 10.1016/j.resuscitation.2023.109748. Epub 2023 Feb 25.
PubMed 36842675Langeland H, Bergum D, Loberg M, Bjornstad K, Skaug TR, Nordseth T, Klepstad P, Skjaervold NK. Characteristics of circulatory failure after out-of-hospital cardiac arrest: a prospective cohort study. Open Heart. 2022 Jan;9(1):e001890. doi: 10.1136/openhrt-2021-001890.
PubMed 35046124
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transitions Between Clinical Circulatory States After Out-of-hospital Cardiac Arrest
- ClinicalTrials.gov ID
- NCT02648061
- Acronym / sponsor ID
- 2015/1807
- Conditions
- Out-of-Hospital Cardiac Arrest
- Keywords
- Blood circulation, Follow-up studies, Biological markers, Hemodynamics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- Jan 2016 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 6 Jan 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.
Extensive research exists for cardio-pulmonary resuscitation (CPR) and the chance of successful return of spontaneous circulation (ROSC) is improved. Unfortunately, the overall prognosis after ROSC has not improved much and the in-hospital mortality is still reported to be 50 to 70 %. The "post-resuscitation disease" is now called the "post-cardiac arrest syndrome" (PCAS) and comprises 1) brain injury, 2) myocardial dysfunction and 3) systemic ischemia and reperfusion.
Treatment of patients after cardiac arrest has often followed guidelines that were primarily developed for treatment of septic shock. It is still uncertain whether this is the optimal way to deliver circulatory support after cardiac arrest.
There is a lack of studies assessing the relationship between the inflammatory response measured by inflammatory biomarkers and circulatory failure in PCAS.
In this study a detailed description will be given of the clinical trajectory of the circulation and the inflammatory response during the first 5 days after cardiac arrest, and it will be investigated whether patterns of circulatory and inflammatory response may be predictive of deterioration of clinical state.
Detailed description
This study will obtain longitudinally advanced hemodynamic observations with high resolution during the acute phase of post cardiac arrest syndrome (PCAS), and analyze the details in clinical transitions related to circulatory failure. The study will also analyze the relationship between inflammatory biomarkers and circulatory failure in PCAS and kinetics of hemodynamics associated with standard interventions in the intensive care unit (ICU).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| After cardiac arrest syndrome (ACAS) | – | –adult patients after out-of-hospital cardiac arrest |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients who are admitted to either the Intensive Care Unit (ICU) or the Coronary Care Unit (CCU) at St. Olav's University Hospital, Trondheim, Norway, after out-of-hospital cardiac arrest will be considered for inclusion.(catchment population of 700,000)
Key inclusion criteria (2 listed)
- Return of spontaneous circulation (ROSC) after out-of-hospital cardiac arrest (OHCA)
- Admitted to Coronary Care Unit (CCU) or Intensive Care Unit (ICU), St. Olav's University Hospital
Key exclusion criteria (3 listed)
- Sepsis within 24 hours before cardiac arrest
- Pregnancy
- Decision of withdrawal or withholding of life prolonging therapy (i.e. due to advanced malignancy)
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
Time in clinical circulatory state (stable, unstable, severe unstable)
Time frame: 5 days
These clinical circulatory states are defined as follows: 1) Stable circulation (Mean blood pressure > 65 mmHg, heart rate 51-100, lactate serum concentrations < 2 mmol/l, ScvO2 > 65, fluid administration < 0.5 l/h, norepinephrine dose < 0.1 microgram/kg/min, no other vasoactive drugs. 2) Unstable circulation (mean blood pressure 45-64 mmHg , heart rate 41-50, 101-130, lactate serum concentrations 2-4 mmol/l, ScvO2 > 50-64, fluid administration 0.5-1,9 l/h, norepinephrine dose 0.1-0.29 microgram/kg/min, Dobutamin > 10 microgram/kg/min, no other vasoactive drugs) 3) Severe unstable circulation (mean blood pressure < 45 mmHg , heart rate < 40, > 130, lactate serum concentrations >4 mmol/l, ScvO2 < 50, fluid administration > 2.0 l/h, norepinephrine dose 0.3 or above microgram/kg/min, dobutamin > 10 microgram/kg/min, other vasoactive drugs, use of aortic balloon pump).
1 secondary outcome
Interleukin-6 in relation to dose of Norepinephrine used to correct vasoplegia after cardiac arrest
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 4 Feb 2022.
- Background: PubMed 29351897Langeland H, Bergum D, Loberg M, Bjornstad K, Damas JK, Mollnes TE, Skjaervold NK, Klepstad P. Transitions Between Circulatory States After Out-of-Hospital Cardiac Arrest: Protocol for an Observational, Prospective Cohort Study. JMIR Res Protoc. 2018 Jan 19;7(1):e17. doi: 10.2196/resprot.8558.
- Results publication: PubMed 34496748Langeland H, Bergum D, Nordseth T, Loberg M, Skaug T, Bjornstad K, Gundersen O, Skjaervold NK, Klepstad P. Circulatory trajectories after out-of-hospital cardiac arrest: a prospective cohort study. BMC Anesthesiol. 2021 Sep 8;21(1):219. doi: 10.1186/s12871-021-01434-2.
- Results publication: PubMed 34838662Langeland H, Damas JK, Mollnes TE, Ludviksen JK, Ueland T, Michelsen AE, Loberg M, Bergum D, Nordseth T, Skjaervold NK, Klepstad P. The inflammatory response is related to circulatory failure after out-of-hospital cardiac arrest: A prospective cohort study. Resuscitation. 2022 Jan;170:115-125. doi: 10.1016/j.resuscitation.2021.11.026. Epub 2021 Nov 24.
- Derived from this study: PubMed 38666252Farbu BH, Lydersen S, Mohus RM, Ueland T, Mollnes TE, Klepstad P, Langeland H. The detrimental effects of intestinal injury mediated by inflammation are limited in cardiac arrest patients: A prospective cohort study. Resusc Plus. 2024 Apr 17;18:100639. doi: 10.1016/j.resplu.2024.100639. eCollection 2024 Jun.
- Derived from this study: PubMed 36842675Hoftun Farbu B, Langeland H, Ueland T, Michelsen AE, Jorstad Kruger A, Klepstad P, Nordseth T. Intestinal injury in cardiac arrest is associated with multiple organ dysfunction: A prospective cohort study. Resuscitation. 2023 Apr;185:109748. doi: 10.1016/j.resuscitation.2023.109748. Epub 2023 Feb 25.
- Derived from this study: PubMed 35046124Langeland H, Bergum D, Loberg M, Bjornstad K, Skaug TR, Nordseth T, Klepstad P, Skjaervold NK. Characteristics of circulatory failure after out-of-hospital cardiac arrest: a prospective cohort study. Open Heart. 2022 Jan;9(1):e001890. doi: 10.1136/openhrt-2021-001890.
- 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.
Toril Hernes, prof study director
Norwegian University of Science and Technology
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 Out-of-Hospital Cardiac Arrest, run by Norwegian University of Science and Technology at 1 site in Norway.
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 2 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 4 Feb 2022. 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 Norway. 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?
Time in clinical circulatory state (stable, unstable, severe unstable) (time frame: 5 days). 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 NCT02648061, which also lists 6 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 4 Feb 2022.