Clinical trial NCT02648061: Transitions Between Clinical Circulatory States After Out-of-hospital Cardiac Arrest
Official title: Transitions Between Clinical Circulatory States After Out-of-hospital Cardiac Arrest
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Out-of-Hospital Cardiac Arrest
Keywords: Blood circulation
Follow-up studies
Biological markers
Hemodynamics
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2016-01-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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)

Brief 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 %. 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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Sepsis within 24 hours before cardiac arrest
* Pregnancy
* Decision of withdrawal or withholding of life prolonging therapy (i.e. due to advanced malignancy)

Primary outcomes:
measure: Time in clinical circulatory state (stable, unstable, severe unstable)
timeFrame: 5 days
Secondary outcomes:
measure: Interleukin-6 in relation to dose of Norepinephrine used to correct vasoplegia after cardiac arrest
timeFrame: 5 days
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital Trondheim University Hospital
Study officials:
affiliation: Norwegian University of Science and Technology
name: Toril Hernes, prof
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Langeland 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.
citation: Langeland 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.
citation: Langeland 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.