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

NCT02648061 | Completed

• 1 other identifier: 2015/1807
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Out-of-Hospital Cardiac Arrest

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Interleukin-6 in relation to dose of Norepinephrine used to correct vasoplegia after cardiac arrest

  5 days

Study Arms (1)

After cardiac arrest syndrome (ACAS)

adult patients after out-of-hospital cardiac arrest

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator

Study Sites (1)

St Olavs Hospital Trondheim University Hospital

Trondheim, Norway

Location

Related Publications (6)

• 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.

  PMID: 29351897 BACKGROUND

• 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.

  PMID: 34496748 RESULT

• 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.

  PMID: 34838662 RESULT

• Farbu 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.

  PMID: 38666252 DERIVED

• Hoftun 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.

  PMID: 36842675 DERIVED

• 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.

  PMID: 35046124 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases

Study Officials

• Toril Hernes, prof

  Norwegian University of Science and Technology

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2015
• First Posted: January 6, 2016
• Study Start: January 1, 2016
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: February 4, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)