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

Out-of-Hospital Cardiac Arrest Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02648061
• Other study ID #: 2015/1807
• Status: Completed
• Start date: January 2016
• Est. completion date: December 31, 2017

Study information

• Verified date: January 2022
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 %. 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Heart Arrest
• Out-of-Hospital Cardiac Arrest

Locations

Country	Name	City	State
Norway	St Olavs Hospital Trondheim University Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (3)

Langeland H, Bergum D, Løberg M, Bjørnstad K, Damås JK, Mollnes TE, Skjærvold 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. — View Citation

Langeland H, Bergum D, Nordseth T, Løberg M, Skaug T, Bjørnstad K, Gundersen Ø, Skjærvold 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 — View Citation

Langeland H, Damås JK, Mollnes TE, Ludviksen JK, Ueland T, Michelsen AE, Løberg M, Bergum D, Nordseth T, Skjærvold NK, Klepstad P. The inflammatory response is related to circulatory failure after out-of-hospital cardiac arrest: A prospective cohort study — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.; 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).	5 days
Secondary	Interleukin-6 in relation to dose of Norepinephrine used to correct vasoplegia after cardiac arrest		5 days