Intensive Care Unit Management After Cardiac ARrest in Russia

NCT ID: NCT04608825

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-11
• Study Completion Date: 2023-12-11

Brief Summary

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.

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.

Conditions

Post Cardiac Arrest Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Russian Federation of Anesthesiologists and Reanimatologists

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vladimir Gorbachev, MD

Role: PRINCIPAL_INVESTIGATOR

CEO Irkutsk State Medical Academy of Postgraduate Education

Locations

CEO Irkutsk State Medical Academy of Postgraduate Education - Branch Campus of the FSBEI FPE RMACPE MOH Russia

Irkutsk, , Russia

City Clinical Hospital No.3

Irkutsk, , Russia

Irkutsk City Clinical Hospital No.1

Irkutsk, , Russia

Kuzbass Clinical Emergency Hospital named after M.A. Podgorbunsky

Kemerovo, , Russia

Krasnoyarsk interdistrict clinical hospital of emergency medical care named after NS Karpovich

Krasnoyarsk, , Russia

Krasnoyarsk interdistrict clinical hospital №20 named after I.S. Berzona Krasnoyarsk, Russia

Krasnoyarsk, , Russia

Krasnoyarsk interdistrict clinical hospital №4 Krasnoyarsk, Russia

Krasnoyarsk, , Russia

Regional clinical hospital

Krasnoyarsk, , Russia

Federal research and clinical center of intensive care medicine and rehabilitology

Moscow, , Russia

Orenburg City N.I. Pirogov Clinical Hospital

Orenburg, , Russia

Orenburg regional clinical hospital

Orenburg, , Russia

Countries

Russia

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Other Identifiers

FARCT0003

Identifier Type: -

Identifier Source: org_study_id