Healthcare-associated Infections in Severe COVID-19 During 2020 (COVIACS)

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ClinicalTrials.gov Identifier: NCT04819165

Recruitment Status : Completed

First Posted : March 26, 2021

Last Update Posted : March 26, 2021

Sponsor:

Information provided by (Responsible Party):

Matias Accoce, Sanatorio Anchorena San Martin

Study Description

Brief Summary:

In patients who develop ARDS due to SARS-CoV-2 (CARDS), a longer duration of invasive mechanical ventilation (IMV) and ICU stay has been reported compared to ARDS not associated with SARS-CoV-2. Consequently, the days of stay in ICU increase Identifying the risk factors associated with the development of this complication and developing measures aimed at its prevention could have a favorable impact on the clinical course of seriously ill patients.

Condition or disease	Intervention/treatment
Respiration, Artificial COVID-19 Health Care Associated Infection	Other: COVID-19

Detailed Description:

The rate of catheter-associated bacteremia is 3.78 / 1000 days central venous catheters in polyvalent ICUs.

Some studies suggest that in the context of this pandemic, infections associated with health care have increased, although there are few data referring to Latin America.

The objective of this study is to analyze the incidence of health care associated infections in adult patients on invasive mechanical ventilation with confirmed COVID-19 diagnosis and negative COVID-19 admitted to the Intensive Care Unit of the Anchorena San Martín Clinic, San Martín, Buenos Aires.

Study Design

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Study Type :	Observational
Actual Enrollment :	252 participants
Observational Model:	Cohort
Time Perspective:	Retrospective
Official Title:	Healthcare-associated Infections in Severe COVID-19 Patients Whit Mechanical Ventilation During 2020
Actual Study Start Date :	March 1, 2020
Actual Primary Completion Date :	December 31, 2020
Actual Study Completion Date :	January 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COVID-19 (Coronavirus Disease 2019)

Genetic and Rare Diseases Information Center resources: Oculocerebral Syndrome With Hypopigmentation

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
COVID-19 patients Patients with invasive mechanical ventilation admitted to the Intensive Care Unit (UCI) of the Anchorena San Martín Clinic, San Martín, Buenos Aires with confirmed COVID-19 diagnosis (positive polymerase chain reaction in nasopharyngeal swab).	Other: COVID-19 Impact of covid-19 on infections associated with health care devices.
non COVID-19 patients Patients with invasive mechanical ventilation admitted to the Intensive Care Unit (UCI) of the Anchorena San Martín Clinic, San Martín, Buenos Aires with negative COVID-19 diagnosis (positive polymerase chain reaction in nasopharyngeal swab).

Outcome Measures

Primary Outcome Measures :

Incidence of health care associated infections in each group. [ Time Frame: March to December 2020 ]

Secondary Outcome Measures :

The most frequent pathogens in this population associated with Incidence of health care associated infections. [ Time Frame: March to December 2020 ]
Possible factors associated with Incidence of health care associated infections. [ Time Frame: March to December 2020 ]
mortality in UCI [ Time Frame: March to December 2020 ]
Days of ICU stay [ Time Frame: March to December 2020 ]
Days of mechanical ventilation [ Time Frame: March to December 2020 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients admitted to ICU who required invasive mechanical ventilation during the COVID-19 pandemic from March to December 2020.

Criteria

Inclusion Criteria:

All patients older than 18 years admitted to the intensive care unit of the Anchorena San Martín Clinic who required invasive mechanical ventilation for more than 24 hours in a period between March 2020 and December 2020 were included in the analysis.

Exclusion Criteria:

All patients who presented incomplete data in the follow-up sheets were excluded.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04819165

Locations

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Argentina
Sanatorio Anchorena de San Martin
San Martín, Buenos Aires, Argentina, B1650CQU

Sponsors and Collaborators

Sanatorio Anchorena San Martin

Investigators

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Principal Investigator:	matias accoce	SAnchorena San Martin

More Information

Publications of Results:

Tufan A, Avanoğlu Güler A, Matucci-Cerinic M. COVID-19, immune system response, hyperinflammation and repurposing antirheumatic drugs. Turk J Med Sci. 2020 Apr 21;50(SI-1):620-632. doi: 10.3906/sag-2004-168. Review.

Ripa M, Galli L, Poli A, Oltolini C, Spagnuolo V, Mastrangelo A, Muccini C, Monti G, De Luca G, Landoni G, Dagna L, Clementi M, Rovere Querini P, Ciceri F, Tresoldi M, Lazzarin A, Zangrillo A, Scarpellini P, Castagna A; COVID-BioB study group. Secondary infections in patients hospitalized with COVID-19: incidence and predictive factors. Clin Microbiol Infect. 2021 Mar;27(3):451-457. doi: 10.1016/j.cmi.2020.10.021. Epub 2020 Oct 24.

Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291. Erratum in: JAMA. 2016 Jul 19;316(3):350. JAMA. 2016 Jul 19;316(3):350.

Kalanuria AA, Ziai W, Mirski M. Ventilator-associated pneumonia in the ICU. Crit Care. 2014 Mar 18;18(2):208. doi: 10.1186/cc13775. Review. Erratum in: Crit Care. 2016;20:29. Zai, Wendy [corrected to Ziai, Wendy].

Rouzé A, Nseir S. Continuous control of tracheal cuff pressure for the prevention of ventilator-associated pneumonia in critically ill patients: where is the evidence? Curr Opin Crit Care. 2013 Oct;19(5):440-7. doi: 10.1097/MCC.0b013e3283636b71. Review.

Duszyńska W, Rosenthal VD, Szczęsny A, Woźnica E, Ulfik K, Ostrowska E, Litwin A, Kübler A. Urinary tract infections in intensive care unit patients - a single-centre, 3-year observational study according to the INICC project. Anaesthesiol Intensive Ther. 2016;48(1):1-6. doi: 10.5603/AIT.2016.0001.

Rosenthal VD, Dwivedy A, Calderón ME, Esen S, Hernández HT, Abouqal R, Medeiros EA, Espinoza TA, Kanj SS, Gikas A, Barnett AG, Graves N; International Nosocomial Infection Control Consortium (INICC) Members. Time-dependent analysis of length of stay and mortality due to urinary tract infections in ten developing countries: INICC findings. J Infect. 2011 Feb;62(2):136-41. doi: 10.1016/j.jinf.2010.12.004. Epub 2010 Dec 17.

Rouzé A, Martin-Loeches I, Povoa P, Makris D, Artigas A, Bouchereau M, Lambiotte F, Metzelard M, Cuchet P, Boulle Geronimi C, Labruyere M, Tamion F, Nyunga M, Luyt CE, Labreuche J, Pouly O, Bardin J, Saade A, Asfar P, Baudel JL, Beurton A, Garot D, Ioannidou I, Kreitmann L, Llitjos JF, Magira E, Mégarbane B, Meguerditchian D, Moglia E, Mekontso-Dessap A, Reignier J, Turpin M, Pierre A, Plantefeve G, Vinsonneau C, Floch PE, Weiss N, Ceccato A, Torres A, Duhamel A, Nseir S; coVAPid study Group. Relationship between SARS-CoV-2 infection and the incidence of ventilator-associated lower respiratory tract infections: a European multicenter cohort study. Intensive Care Med. 2021 Feb;47(2):188-198. doi: 10.1007/s00134-020-06323-9. Epub 2021 Jan 3. Erratum in: Intensive Care Med. 2021 Nov 24;:.

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Responsible Party:	Matias Accoce, RT, Sanatorio Anchorena San Martin
ClinicalTrials.gov Identifier:	NCT04819165
Other Study ID Numbers:	5/2021
First Posted:	March 26, 2021 Key Record Dates
Last Update Posted:	March 26, 2021
Last Verified:	March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Infections Communicable Diseases COVID-19 Cross Infection Disease Attributes Pathologic Processes Respiratory Tract Infections Pneumonia, Viral Pneumonia	Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Iatrogenic Disease

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