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

January 20, 2022 updated by: Norwegian University of Science and Technology

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.

Study Overview

Status

Completed

Conditions

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).

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway
        • St Olavs Hospital Trondheim University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
After cardiac arrest syndrome (ACAS)
adult patients after out-of-hospital cardiac arrest

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
5 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Interleukin-6 in relation to dose of Norepinephrine used to correct vasoplegia after cardiac arrest
Time Frame: 5 days
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

St. Olavs Hospital

Investigators

  • Study Director: Toril Hernes, prof, Norwegian University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

December 4, 2015

First Submitted That Met QC Criteria

January 4, 2016

First Posted (Estimate)

January 6, 2016

Study Record Updates

Last Update Posted (Actual)

February 4, 2022

Last Update Submitted That Met QC Criteria

January 20, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015/1807

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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