Intensive Care Unit Management After Cardiac ARrest in Russia

Post Cardiac Arrest Syndrome Clinical Trial

— ICAR-RUS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04608825
• Other study ID #: FARCT0003
• Status: Recruiting
• Start date: November 11, 2020
• Est. completion date: November 11, 2023

Study information

• Verified date: May 2023
• Source: Russian Federation of Anesthesiologists and Reanimatologists
• Contact: Vladimir Gorbachev, MD
• Phone: +79025666389
• Email: gorbachevvi[@]yandex.ru
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: November 11, 2023
• Est. primary completion date: November 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Arrest
• Post Cardiac Arrest Syndrome
• Post-Cardiac Arrest Syndrome

Locations

Country	Name	City	State
Russian Federation	CEO Irkutsk State Medical Academy of Postgraduate Education - Branch Campus of the FSBEI FPE RMACPE MOH Russia	Irkutsk
Russian Federation	City Clinical Hospital No.3	Irkutsk
Russian Federation	Irkutsk City Clinical Hospital No.1	Irkutsk
Russian Federation	Kuzbass Clinical Emergency Hospital named after M.A. Podgorbunsky	Kemerovo
Russian Federation	Krasnoyarsk interdistrict clinical hospital ?20 named after I.S. Berzona Krasnoyarsk, Russia	Krasnoyarsk
Russian Federation	Krasnoyarsk interdistrict clinical hospital ?4 Krasnoyarsk, Russia	Krasnoyarsk
Russian Federation	Krasnoyarsk interdistrict clinical hospital of emergency medical care named after NS Karpovich	Krasnoyarsk
Russian Federation	Regional clinical hospital	Krasnoyarsk
Russian Federation	Federal research and clinical center of intensive care medicine and rehabilitology	Moscow
Russian Federation	Orenburg City N.I. Pirogov Clinical Hospital	Orenburg
Russian Federation	Orenburg regional clinical hospital	Orenburg

Sponsors (1)

Lead Sponsor	Collaborator
Russian Federation of Anesthesiologists and Reanimatologists

Country where clinical trial is conducted

Russian Federation, 

References & Publications (18)

Andersen LW, Holmberg MJ, Berg KM, Donnino MW, Granfeldt A. In-Hospital Cardiac Arrest: A Review. JAMA. 2019 Mar 26;321(12):1200-1210. doi: 10.1001/jama.2019.1696. — View Citation

Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. No abstract available. Erratum In: Circulation. 2017 Mar 7;135(10 ):e646. Circulation. 2017 Sep 5;136(10 ):e196. — View Citation

Capani F, Della Loggia F, Sensi S. [Pancreatic diabetes. Diagnosis and therapy]. Minerva Med. 1976 Jan 28;67(4):301-6. No abstract available. Italian. — View Citation

Chan PS, McNally B, Tang F, Kellermann A; CARES Surveillance Group. Recent trends in survival from out-of-hospital cardiac arrest in the United States. Circulation. 2014 Nov 18;130(21):1876-82. doi: 10.1161/CIRCULATIONAHA.114.009711. — View Citation

Chan PS, Nallamothu BK, Krumholz HM, Spertus JA, Li Y, Hammill BG, Curtis LH; American Heart Association Get with the Guidelines-Resuscitation Investigators. Long-term outcomes in elderly survivors of in-hospital cardiac arrest. N Engl J Med. 2013 Mar 14;368(11):1019-26. doi: 10.1056/NEJMoa1200657. — View Citation

Dellinger RP, Levy MM, Rhodes A, Annane D, Gerlach H, Opal SM, Sevransky JE, Sprung CL, Douglas IS, Jaeschke R, Osborn TM, Nunnally ME, Townsend SR, Reinhart K, Kleinpell RM, Angus DC, Deutschman CS, Machado FR, Rubenfeld GD, Webb S, Beale RJ, Vincent JL, Moreno R; Surviving Sepsis Campaign Guidelines Committee including The Pediatric Subgroup. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock, 2012. Intensive Care Med. 2013 Feb;39(2):165-228. doi: 10.1007/s00134-012-2769-8. Epub 2013 Jan 30. — View Citation

Deye N, Cariou A, Girardie P, Pichon N, Megarbane B, Midez P, Tonnelier JM, Boulain T, Outin H, Delahaye A, Cravoisy A, Mercat A, Blanc P, Santre C, Quintard H, Brivet F, Charpentier J, Garrigue D, Francois B, Quenot JP, Vincent F, Gueugniaud PY, Mira JP, Carli P, Vicaut E, Baud FJ; Clinical and Economical Impact of Endovascular Cooling in the Management of Cardiac Arrest (ICEREA) Study Group. Endovascular Versus External Targeted Temperature Management for Patients With Out-of-Hospital Cardiac Arrest: A Randomized, Controlled Study. Circulation. 2015 Jul 21;132(3):182-93. doi: 10.1161/CIRCULATIONAHA.114.012805. Epub 2015 Jun 19. Erratum In: Circulation. 2016 Feb 23;133(8):e418. — View Citation

Dragancea I, Rundgren M, Englund E, Friberg H, Cronberg T. The influence of induced hypothermia and delayed prognostication on the mode of death after cardiac arrest. Resuscitation. 2013 Mar;84(3):337-42. doi: 10.1016/j.resuscitation.2012.09.015. Epub 2012 Sep 20. — View Citation

Elmer J, Scutella M, Pullalarevu R, Wang B, Vaghasia N, Trzeciak S, Rosario-Rivera BL, Guyette FX, Rittenberger JC, Dezfulian C; Pittsburgh Post-Cardiac Arrest Service (PCAS). The association between hyperoxia and patient outcomes after cardiac arrest: analysis of a high-resolution database. Intensive Care Med. 2015 Jan;41(1):49-57. doi: 10.1007/s00134-014-3555-6. Epub 2014 Dec 4. — View Citation

Grasner JT, Meybohm P, Lefering R, Wnent J, Bahr J, Messelken M, Jantzen T, Franz R, Scholz J, Schleppers A, Bottiger BW, Bein B, Fischer M; German Resuscitation Registry Study Group. ROSC after cardiac arrest--the RACA score to predict outcome after out-of-hospital cardiac arrest. Eur Heart J. 2011 Jul;32(13):1649-56. doi: 10.1093/eurheartj/ehr107. Epub 2011 Apr 22. — View Citation

Jakkula P, Reinikainen M, Hastbacka J, Loisa P, Tiainen M, Pettila V, Toppila J, Lahde M, Backlund M, Okkonen M, Bendel S, Birkelund T, Pulkkinen A, Heinonen J, Tikka T, Skrifvars MB; COMACARE study group. Targeting two different levels of both arterial carbon dioxide and arterial oxygen after cardiac arrest and resuscitation: a randomised pilot trial. Intensive Care Med. 2018 Dec;44(12):2112-2121. doi: 10.1007/s00134-018-5453-9. Epub 2018 Nov 14. — View Citation

Lemiale V, Dumas F, Mongardon N, Giovanetti O, Charpentier J, Chiche JD, Carli P, Mira JP, Nolan J, Cariou A. Intensive care unit mortality after cardiac arrest: the relative contribution of shock and brain injury in a large cohort. Intensive Care Med. 2013 Nov;39(11):1972-80. doi: 10.1007/s00134-013-3043-4. Epub 2013 Aug 14. — View Citation

Merchant RM, Yang L, Becker LB, Berg RA, Nadkarni V, Nichol G, Carr BG, Mitra N, Bradley SM, Abella BS, Groeneveld PW; American Heart Association Get With The Guidelines-Resuscitation Investigators. Incidence of treated cardiac arrest in hospitalized patients in the United States. Crit Care Med. 2011 Nov;39(11):2401-6. doi: 10.1097/CCM.0b013e3182257459. — View Citation

Mulder M, Gibbs HG, Smith SW, Dhaliwal R, Scott NL, Sprenkle MD, Geocadin RG. Awakening and withdrawal of life-sustaining treatment in cardiac arrest survivors treated with therapeutic hypothermia*. Crit Care Med. 2014 Dec;42(12):2493-9. doi: 10.1097/CCM.0000000000000540. — View Citation

Nolan JP, Berg RA, Callaway CW, Morrison LJ, Nadkarni V, Perkins GD, Sandroni C, Skrifvars MB, Soar J, Sunde K, Cariou A. The present and future of cardiac arrest care: international experts reach out to caregivers and healthcare authorities. Intensive Care Med. 2018 Jun;44(6):823-832. doi: 10.1007/s00134-018-5230-9. Epub 2018 Jun 2. — View Citation

Perman SM, Stanton E, Soar J, Berg RA, Donnino MW, Mikkelsen ME, Edelson DP, Churpek MM, Yang L, Merchant RM; American Heart Association's Get With the Guidelines(R)-Resuscitation (formerly the National Registry of Cardiopulmonary Resuscitation) Investigators. Location of In-Hospital Cardiac Arrest in the United States-Variability in Event Rate and Outcomes. J Am Heart Assoc. 2016 Sep 29;5(10):e003638. doi: 10.1161/JAHA.116.003638. — View Citation

Ritter MM, Sonnichsen AC, Mohrle W, Richter WO, Schwandt P. Beta-endorphin plasma levels and their dependence on gender during an enteral glucose load in lean subjects as well as in obese patients before and after weight reduction. Int J Obes. 1991 Jun;15(6):421-7. — View Citation

Zylke JW. Drug war intelligence gathering: risky, but useful to physicians. JAMA. 1988 Oct 21;260(15):2169-70. No abstract available. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of PCAS in the ICU	post cardiac arrest syndrome in patients of intensive care unit	during each patient hospitalization, an average of 1 month