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Transitions Between Clinical Circulatory States After Out-of-hospital Cardiac Arrest

Transitions Between Clinical Circulatory States After Out-of-hospital Cardiac Arrest

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02648061
Enrollment
50
Registered
2016-01-06
Start date
2016-01-31
Completion date
2017-12-31
Last updated
2022-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Out-of-Hospital Cardiac Arrest

Keywords

Blood circulation, Follow-up studies, Biological markers, Hemodynamics

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).

Interventions

None listed

Sponsors

St. Olavs Hospital
CollaboratorOTHER
Norwegian University of Science and Technology
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Time in clinical circulatory state (stable, unstable, severe unstable)5 daysThese 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).

Secondary

MeasureTime frame
Interleukin-6 in relation to dose of Norepinephrine used to correct vasoplegia after cardiac arrest5 days

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026