Clinical Trial: Transitions Between Clinical Circulatory States After Out-of-hospital Cardiac Arrest
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Transitions Between Clinical Circulatory States After Out-of-hospital Cardiac Arrest
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 Summary: 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).
Sponsor: Norwegian University of Science and Technology
Current 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).
Original Primary Outcome: Same as current
Current Secondary Outcome: Interleukin-6 in relation to dose of Norepinephrine used to correct vasoplegia after cardiac arrest [ Time Frame: 5 days ]
Original Secondary Outcome: Same as current
Information By: Norwegian University of Science and Technology
Dates:
Date Received: December 4, 2015
Date Started: January 2016
Date Completion: January 2018
Last Updated: January 17, 2017
Last Verified: January 2017
