Undersøgelse af behandling og resultater hos kritisk syge patienter med COVID-19 (STOP-COVID)
6. august 2023 opdateret af: David Leaf, Brigham and Women's Hospital
Multicenter observations-/registerundersøgelse af de kliniske træk og resultater af kritisk syge patienter med COVID-19.
Studieoversigt
Detaljeret beskrivelse
Målet med dette projekt er at bestemme de uafhængige risikofaktorer for hospitalsdødelighed og akut organskade og at identificere behandlingsstrategier forbundet med forbedret overlevelse.
Derudover vil vi vurdere resultater i henhold til forskelle i geografiske og institutionelle parametre.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
5154
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02115
- Brigham and Women's Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Kritisk syge voksne indlagt på intensivafdeling for sygdom relateret til COVID-19
Beskrivelse
Inklusionskriterier (hvert af følgende):
- Voksne (i alderen ≥18 år)
- Laboratoriebekræftet diagnose af COVID-19
- Indlagt på ICU for sygdom relateret til COVID-19
Ekskluderingskriterier:
-Ingen
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Andet
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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28-dages dødelighed
Tidsramme: 28 dage fra dagen for ICU-indlæggelse
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28 dage fra dagen for ICU-indlæggelse
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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60-dages dødelighed
Tidsramme: 60 dage fra dagen for ICU-indlæggelse
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60 dage fra dagen for ICU-indlæggelse
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90-dages dødelighed
Tidsramme: 90 dage fra dagen for ICU-indlæggelse
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90 dage fra dagen for ICU-indlæggelse
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: David E Leaf, MD, MMSc, Brigham and Women's Hospital
- Studieleder: Shruti Gupta, MD, MPH, Brigham and Women's Hospital
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Gupta S, Hayek SS, Wang W, Chan L, Mathews KS, Melamed ML, Brenner SK, Leonberg-Yoo A, Schenck EJ, Radbel J, Reiser J, Bansal A, Srivastava A, Zhou Y, Sutherland A, Green A, Shehata AM, Goyal N, Vijayan A, Velez JCQ, Shaefi S, Parikh CR, Arunthamakun J, Athavale AM, Friedman AN, Short SAP, Kibbelaar ZA, Abu Omar S, Admon AJ, Donnelly JP, Gershengorn HB, Hernan MA, Semler MW, Leaf DE; STOP-COVID Investigators. Factors Associated With Death in Critically Ill Patients With Coronavirus Disease 2019 in the US. JAMA Intern Med. 2020 Nov 1;180(11):1436-1447. doi: 10.1001/jamainternmed.2020.3596. Erratum In: JAMA Intern Med. 2020 Nov 1;180(11):1555. JAMA Intern Med. 2021 Aug 1;181(8):1144.
- Gupta S, Wang W, Hayek SS, Chan L, Mathews KS, Melamed ML, Brenner SK, Leonberg-Yoo A, Schenck EJ, Radbel J, Reiser J, Bansal A, Srivastava A, Zhou Y, Finkel D, Green A, Mallappallil M, Faugno AJ, Zhang J, Velez JCQ, Shaefi S, Parikh CR, Charytan DM, Athavale AM, Friedman AN, Redfern RE, Short SAP, Correa S, Pokharel KK, Admon AJ, Donnelly JP, Gershengorn HB, Douin DJ, Semler MW, Hernan MA, Leaf DE; STOP-COVID Investigators. Association Between Early Treatment With Tocilizumab and Mortality Among Critically Ill Patients With COVID-19. JAMA Intern Med. 2021 Jan 1;181(1):41-51. doi: 10.1001/jamainternmed.2020.6252. Erratum In: JAMA Intern Med. 2021 Apr 1;181(4):570.
- Hayek SS, Brenner SK, Azam TU, Shadid HR, Anderson E, Berlin H, Pan M, Meloche C, Feroz R, O'Hayer P, Kaakati R, Bitar A, Padalia K, Perry D, Blakely P, Gupta S, Shaefi S, Srivastava A, Charytan DM, Bansal A, Mallappallil M, Melamed ML, Shehata AM, Sunderram J, Mathews KS, Sutherland AK, Nallamothu BK, Leaf DE; STOP-COVID Investigators. In-hospital cardiac arrest in critically ill patients with covid-19: multicenter cohort study. BMJ. 2020 Sep 30;371:m3513. doi: 10.1136/bmj.m3513.
- Molnar MZ, Bhalla A, Azhar A, Tsujita M, Talwar M, Balaraman V, Sodhi A, Kadaria D, Eason JD, Hayek SS, Coca SG, Shaefi S, Neyra JA, Gupta S, Leaf DE, Kovesdy CP; STOP-COVID Investigators. Outcomes of critically ill solid organ transplant patients with COVID-19 in the United States. Am J Transplant. 2020 Nov;20(11):3061-3071. doi: 10.1111/ajt.16280. Epub 2020 Sep 15.
- Leaf RK, Al-Samkari H, Brenner SK, Gupta S, Leaf DE. ABO phenotype and death in critically ill patients with COVID-19. Br J Haematol. 2020 Aug;190(4):e204-e208. doi: 10.1111/bjh.16984. Epub 2020 Jul 30. No abstract available.
- Flythe JE, Assimon MM, Tugman MJ, Chang EH, Gupta S, Shah J, Sosa MA, Renaghan AD, Melamed ML, Wilson FP, Neyra JA, Rashidi A, Boyle SM, Anand S, Christov M, Thomas LF, Edmonston D, Leaf DE; STOP-COVID Investigators. Characteristics and Outcomes of Individuals With Pre-existing Kidney Disease and COVID-19 Admitted to Intensive Care Units in the United States. Am J Kidney Dis. 2021 Feb;77(2):190-203.e1. doi: 10.1053/j.ajkd.2020.09.003. Epub 2020 Sep 19.
- Easter SR, Gupta S, Brenner SK, Leaf DE. Outcomes of Critically Ill Pregnant Women with COVID-19 in the United States. Am J Respir Crit Care Med. 2021 Jan 1;203(1):122-125. doi: 10.1164/rccm.202006-2182LE. No abstract available.
- Al-Samkari H, Gupta S, Leaf RK, Wang W, Rosovsky RP, Brenner SK, Hayek SS, Berlin H, Kapoor R, Shaefi S, Melamed ML, Sutherland A, Radbel J, Green A, Garibaldi BT, Srivastava A, Leonberg-Yoo A, Shehata AM, Flythe JE, Rashidi A, Goyal N, Chan L, Mathews KS, Hedayati SS, Dy R, Toth-Manikowski SM, Zhang J, Mallappallil M, Redfern RE, Bansal AD, Short SAP, Vangel MG, Admon AJ, Semler MW, Bauer KA, Hernan MA, Leaf DE; STOP-COVID Investigators. Thrombosis, Bleeding, and the Observational Effect of Early Therapeutic Anticoagulation on Survival in Critically Ill Patients With COVID-19. Ann Intern Med. 2021 May;174(5):622-632. doi: 10.7326/M20-6739. Epub 2021 Jan 26. Erratum In: Ann Intern Med. 2021 Jun;174(6):888.
- Shaefi S, Brenner SK, Gupta S, O'Gara BP, Krajewski ML, Charytan DM, Chaudhry S, Mirza SH, Peev V, Anderson M, Bansal A, Hayek SS, Srivastava A, Mathews KS, Johns TS, Leonberg-Yoo A, Green A, Arunthamakun J, Wille KM, Shaukat T, Singh H, Admon AJ, Semler MW, Hernan MA, Mueller AL, Wang W, Leaf DE; STOP-COVID Investigators. Extracorporeal membrane oxygenation in patients with severe respiratory failure from COVID-19. Intensive Care Med. 2021 Feb;47(2):208-221. doi: 10.1007/s00134-020-06331-9. Epub 2021 Feb 2.
- Short SAP, Gupta S, Brenner SK, Hayek SS, Srivastava A, Shaefi S, Singh H, Wu B, Bagchi A, Al-Samkari H, Dy R, Wilkinson K, Zakai NA, Leaf DE; STOP-COVID Investigators. d-dimer and Death in Critically Ill Patients With Coronavirus Disease 2019. Crit Care Med. 2021 May 1;49(5):e500-e511. doi: 10.1097/CCM.0000000000004917.
- Mathews KS, Soh H, Shaefi S, Wang W, Bose S, Coca S, Gupta S, Hayek SS, Srivastava A, Brenner SK, Radbel J, Green A, Sutherland A, Leonberg-Yoo A, Shehata A, Schenck EJ, Short SAP, Hernan MA, Chan L, Leaf DE; STOP-COVID Investigators. Prone Positioning and Survival in Mechanically Ventilated Patients With Coronavirus Disease 2019-Related Respiratory Failure. Crit Care Med. 2021 Jul 1;49(7):1026-1037. doi: 10.1097/CCM.0000000000004938.
- Douin DJ, Shaefi S, Brenner SK, Gupta S, Park I, Wright FL, Mathews KS, Chan L, Al-Samkari H, Orfanos S, Radbel J, Leaf DE. Tissue Plasminogen Activator in Critically Ill Adults with COVID-19. Ann Am Thorac Soc. 2021 Nov;18(11):1917-1921. doi: 10.1513/AnnalsATS.202102-127RL. No abstract available.
- Churpek MM, Gupta S, Spicer AB, Parker WF, Fahrenbach J, Brenner SK, Leaf DE; STOP-COVID Investigators. Hospital-Level Variation in Death for Critically Ill Patients with COVID-19. Am J Respir Crit Care Med. 2021 Aug 15;204(403-411):403-11. doi: 10.1164/rccm.202012-4547OC.
- Vasquez CR, Gupta S, Miano TA, Roche M, Hsu J, Yang W, Holena DN, Reilly JP, Schrauben SJ, Leaf DE, Shashaty MGS; STOP-COVID Investigators. Identification of Distinct Clinical Subphenotypes in Critically Ill Patients With COVID-19. Chest. 2021 Sep;160(3):929-943. doi: 10.1016/j.chest.2021.04.062. Epub 2021 May 6.
- Friedman AN, Guirguis J, Kapoor R, Gupta S, Leaf DE, Timsina LR; STOP-COVID Investigators. Obesity, inflammatory and thrombotic markers, and major clinical outcomes in critically ill patients with COVID-19 in the US. Obesity (Silver Spring). 2021 Oct;29(10):1719-1730. doi: 10.1002/oby.23245. Epub 2021 Aug 6.
- Jezmir JL, Bharadwaj M, Chaitoff A, Diephuis B, Crowley CP, Kishore SP, Goralnick E, Merriam LT, Milliken A, Rhee C, Sadovnikoff N, Shah SB, Gupta S, Leaf DE, Feldman WB, Kim EY; STOP-COVID Investigators. Performance of crisis standards of care guidelines in a cohort of critically ill COVID-19 patients in the United States. Cell Rep Med. 2021 Sep 21;2(9):100376. doi: 10.1016/j.xcrm.2021.100376. Epub 2021 Jul 28.
- Churpek MM, Gupta S, Spicer AB, Hayek SS, Srivastava A, Chan L, Melamed ML, Brenner SK, Radbel J, Madhani-Lovely F, Bhatraju PK, Bansal A, Green A, Goyal N, Shaefi S, Parikh CR, Semler MW, Leaf DE; STOP-COVID Investigators. Machine Learning Prediction of Death in Critically Ill Patients With Coronavirus Disease 2019. Crit Care Explor. 2021 Aug 19;3(8):e0515. doi: 10.1097/CCE.0000000000000515. eCollection 2021 Aug.
- Merriam LT, Bharadwaj M, Jezmir JL, Leaf DE, Kim EY. Protocol to assess performance of crisis standards of care guidelines for clinical triage. STAR Protoc. 2021 Dec 17;2(4):100943. doi: 10.1016/j.xpro.2021.100943. Epub 2021 Nov 10.
- Hsu CM, Gupta S, Tighiouart H, Goyal N, Faugno AJ, Tariq A, Raichoudhury R, Sharma JH, Meyer L, Kshirsagar RK, Jose A, Leaf DE, Weiner DE; STOP-COVID Investigators. Kidney Recovery and Death in Critically Ill Patients With COVID-19-Associated Acute Kidney Injury Treated With Dialysis: The STOP-COVID Cohort Study. Am J Kidney Dis. 2022 Mar;79(3):404-416.e1. doi: 10.1053/j.ajkd.2021.11.004. Epub 2021 Dec 4.
- Toth-Manikowski SM, Caldwell J, Joo M, Chen J, Meza N, Bruinius J, Gupta S, Hannan M, Kagalwalla M, Madrid S, Melamed ML, Pacheco E, Srivastava A, Viamontes C, Lash JP, Leaf DE, Ricardo AC; STOP-COVID Investigators. Sex-related differences in mortality, acute kidney injury, and respiratory failure among critically ill patients with COVID-19. Medicine (Baltimore). 2021 Dec 17;100(50):e28302. doi: 10.1097/MD.0000000000028302.
- Keene AB, Admon AJ, Brenner SK, Gupta S, Lazarous D, Leaf DE, Gershengorn HB; STOP-COVID Investigators. Association of Surge Conditions with Mortality Among Critically Ill Patients with COVID-19. J Intensive Care Med. 2022 Apr;37(4):500-509. doi: 10.1177/08850666211067509. Epub 2021 Dec 23.
- Ricardo AC, Chen J, Toth-Manikowski SM, Meza N, Joo M, Gupta S, Lazarous DG, Leaf DE, Lash JP; STOP-COVID Investigators. Hispanic ethnicity and mortality among critically ill patients with COVID-19. PLoS One. 2022 May 18;17(5):e0268022. doi: 10.1371/journal.pone.0268022. eCollection 2022.
- Vasbinder A, Meloche C, Azam TU, Anderson E, Catalan T, Shadid H, Berlin H, Pan M, O'Hayer P, Padalia K, Blakely P, Khaleel I, Michaud E, Huang Y, Zhao L, Pop-Busui R, Gupta S, Eagle K, Leaf DE, Hayek SS; STOP-COVID Investigatorsdouble dagger. Relationship Between Preexisting Cardiovascular Disease and Death and Cardiovascular Outcomes in Critically Ill Patients With COVID-19. Circ Cardiovasc Qual Outcomes. 2022 Oct;15(10):e008942. doi: 10.1161/CIRCOUTCOMES.122.008942. Epub 2022 Oct 4.
- Gupta S, Coca SG, Chan L, Melamed ML, Brenner SK, Hayek SS, Sutherland A, Puri S, Srivastava A, Leonberg-Yoo A, Shehata AM, Flythe JE, Rashidi A, Schenck EJ, Goyal N, Hedayati SS, Dy R, Bansal A, Athavale A, Nguyen HB, Vijayan A, Charytan DM, Schulze CE, Joo MJ, Friedman AN, Zhang J, Sosa MA, Judd E, Velez JCQ, Mallappallil M, Redfern RE, Bansal AD, Neyra JA, Liu KD, Renaghan AD, Christov M, Molnar MZ, Sharma S, Kamal O, Boateng JO, Short SAP, Admon AJ, Sise ME, Wang W, Parikh CR, Leaf DE; and the STOP-COVID Investigators. AKI Treated with Renal Replacement Therapy in Critically Ill Patients with COVID-19. J Am Soc Nephrol. 2021 Jan;32(1):161-176. doi: 10.1681/ASN.2020060897. Epub 2020 Oct 16.
- Sunderraj A, Cho C, Cai X, Gupta S, Mehta R, Isakova T, Leaf DE, Srivastava A; STOP-COVID Investigators. Modulation of the Association Between Age and Death by Risk Factor Burden in Critically Ill Patients With COVID-19. Crit Care Explor. 2022 Aug 29;4(9):e0755. doi: 10.1097/CCE.0000000000000755. eCollection 2022 Sep.
- Green A, Rachoin JS, Schorr C, Dellinger P, Casey JD, Park I, Gupta S, Baron RM, Shaefi S, Hunter K, Leaf DE; STOP-COVID Investigators. Timing of invasive mechanical ventilation and death in critically ill adults with COVID-19: A multicenter cohort study. PLoS One. 2023 Jun 28;18(6):e0285748. doi: 10.1371/journal.pone.0285748. eCollection 2023.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. april 2020
Primær færdiggørelse (Faktiske)
1. august 2020
Studieafslutning (Faktiske)
1. juli 2023
Datoer for studieregistrering
Først indsendt
9. april 2020
Først indsendt, der opfyldte QC-kriterier
10. april 2020
Først opslået (Faktiske)
13. april 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. august 2023
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. august 2023
Sidst verificeret
1. august 2023
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2007P000003
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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