Intensive Care Unit Management After Cardiac ARrest in Russia (ICAR-RUS)

May 10, 2023 updated by: Russian Federation of Anesthesiologists and Reanimatologists

Intensive Care Unit Management After Cardiac ARrest in Russia. - a Retrospective Observational Multi-center Cohort Study

The purpose of this study is to study the prevalence of post cardiac arrest syndrome (PCAS) among ICU patients, to analyze the effectiveness of intensive care, to assess the factors associated with death and the development of severe neurological deficits.

Study Overview

Status

Recruiting

Conditions

Detailed Description

According to statistics, more than half of patients who have undergone cardiopulmonary resuscitation (CPR) die from acute cardiovascular or cerebral insufficiency caused by global ischemia. The survival rate after cardiac arrest and successful CPR is about 10%, with good neurological recovery from 0.9% to 7.8%.

The most common cause of cardiac arrest is heart failure, followed by respiratory failure. Despite progress in the provision of specialized medical care, the proportion of patients who underwent post cardiac arrest syndrome (PCAS) and discharged from the hospital remains very low, and neurological and mental disorders persist forever.

The prevalence of nosocomial cardiac arrest in adults varies, with an average of 6 to 9 cases per 1000 hospitalizations. The prevalence of nosocomial cardiac arrest in adults varies, with an average of 6 to 9 cases per 1000 hospitalizations. About half of inpatient cardiac arrests occur in specialized wards, and the remaining half in other locations, such as intensive care units (ICU) and operating rooms. Common causes of cardiac arrest include coronary artery disease, pulmonary embolism, poisoning with cardiotoxic agents (drugs, antidepressants, cardiac glycosides), metabolic disorders (most often hypo- or hyperkalemia), and sepsis.

Modern methods of intensive care of PCAS provide good results, but require significant diagnostic, therapeutic, human and economic resources. The recommendations of the European Resuscitation Council and the European Intensive Care Society on post-resuscitation care have had an impact on improving the quality of care. In Russia, such recommendations are not accepted. One of the conditions for the development and implementation of methods aimed at increasing the survival rate of patients with PCAS is the collection of up-to-date information on the prevalence, causes and patterns of the development of the disease.

In recent years In Russia, not a single multicenter study has been published on the statistics of survival after cardiac arrest and the results of intensive care. There is also no single algorithm for the treatment of post cardiac arrest syndrome, with the exception of the organ donation protocol; meanwhile, the majority of patients suffering from severe multiple organ failure in the postresuscitation period cannot be donors and die as a result of the progression of multiple organ failure.

Targeted therapy for PCAS includes respiratory and hemodynamic support, temperature management, laboratory monitoring, and anticonvulsant therapy. Predicting the degree of neurocognitive dysfunction remains a clinically difficult issue.

The study of PCAS is undoubtedly relevant and can help identify a number of additional prognostic factors affecting the outcome of the disease.

The purpose of this study is to examine the prevalence of PCAS in Russia, to analyze the effectiveness of intensive care methods, to evaluate the factors associated with death and the development of severe neurological deficits. Research centers are located on the intensive care units. A multicenter retrospective registry cohort study is planned.

The research centers are located on the basis of the ICU, of the Irkutsk Regional Clinical Hospital, Irkutsk City Clinical Hospital No.1, City Clinical Hospital No.3, Irkutsk; Federal research and clinical center of intensive care medicine and rehabilitology, Moscow; Orenburg regional clinical hospital, Orenburg City N.I. Pirogov Clinical Hospital, Orenburg; Kuzbass Clinical Emergency Hospital named after M.A. Podgorbunsky, Kemerovo; Regional clinical hospital, Krasnoyarsk interdistrict clinical hospital of emergency medical care named after NS Karpovich, Krasnoyarsk interdistrict clinical hospital №20 named after I.S. Berzona, Krasnoyarsk interdistrict clinical hospital №4, Krasnoyarsk.

Against the background of the assessment of vital functions, methods of respiratory support, laboratory data, and drug therapy will be compared. Continuous data will be presented as the median and interquartile range for the nonparametric distribution and as the mean and standard deviation for the parametric distribution. The categorical variables will be presented as the number of patients and the percentage of the total number of patients. For record keeping, an individual registration card.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

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

Study Contact

Study Locations

  • Russian Federation
      • Irkutsk, Russian Federation
        • Recruiting
        • CEO Irkutsk State Medical Academy of Postgraduate Education - Branch Campus of the FSBEI FPE RMACPE MOH Russia
        • Contact:
          • Vladimir Gorbachev, MD
      • Irkutsk, Russian Federation
        • Recruiting
        • City Clinical Hospital No.3
        • Contact:
          • Natalia Bragina
      • Irkutsk, Russian Federation
        • Recruiting
        • Irkutsk City Clinical Hospital No.1
        • Contact:
          • Tatiana Markova
      • Kemerovo, Russian Federation
        • Not yet recruiting
        • Kuzbass Clinical Emergency Hospital named after M.A. Podgorbunsky
        • Contact:
          • Evgeny Grigoriev
      • Krasnoyarsk, Russian Federation
        • Recruiting
        • Krasnoyarsk interdistrict clinical hospital of emergency medical care named after NS Karpovich
        • Contact:
          • Alexey Gritsan
      • Krasnoyarsk, Russian Federation
        • Recruiting
        • Krasnoyarsk interdistrict clinical hospital №20 named after I.S. Berzona Krasnoyarsk, Russia
        • Contact:
          • Alexey Gritsan
      • Krasnoyarsk, Russian Federation
        • Recruiting
        • Krasnoyarsk interdistrict clinical hospital №4 Krasnoyarsk, Russia
        • Contact:
          • Alexey Gritsan
      • Krasnoyarsk, Russian Federation
        • Recruiting
        • Regional Clinical Hospital
        • Contact:
          • Alexey Gritsan
      • Moscow, Russian Federation
        • Recruiting
        • Federal research and clinical center of intensive care medicine and rehabilitology
        • Contact:
          • Artem Kuzovlev
      • Orenburg, Russian Federation
        • Recruiting
        • Orenburg Regional Clinical Hospital
        • Contact:
          • Vadim Ershov
      • Orenburg, Russian Federation
        • Not yet recruiting
        • Orenburg City N.I. Pirogov Clinical Hospital
        • Contact:
          • Vadim Ershov

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

Sampling Method

Non-Probability Sample

Study Population

Patients in ICU

Description

Inclusion Criteria:

  • patients with out-of-hospital and in-hospital successful CPR; ·
  • age - from 18 years old; ·
  • survival after CPR - more than 24 hours.

Exclusion Criteria:

  • age less than 18 years; ·
  • death occurring less than 24 hours after CPR; ·
  • oncological pathology in the terminal stage; ·
  • severe neurological deficits and cognitive dysfunction that occurred before CPR.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of PCAS in the ICU
Time Frame: during each patient hospitalization, an average of 1 month
post cardiac arrest syndrome in patients of intensive care unit
during each patient hospitalization, an average of 1 month

Collaborators and Investigators

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

Sponsor

Russian Federation of Anesthesiologists and Reanimatologists

Investigators

  • Principal Investigator: Vladimir Gorbachev, MD, CEO Irkutsk State Medical Academy of Postgraduate Education

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)

November 11, 2020

Primary Completion (Anticipated)

November 11, 2023

Study Completion (Anticipated)

November 11, 2023

Study Registration Dates

First Submitted

October 21, 2020

First Submitted That Met QC Criteria

October 28, 2020

First Posted (Actual)

October 29, 2020

Study Record Updates

Last Update Posted (Estimate)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 10, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FARCT0003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Clinical Trials on Post Cardiac Arrest Syndrome

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Arab Emirates

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe