Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001300864
Ethics application status
Approved
Date submitted
10/08/2021
Date registered
27/09/2021
Date last updated
27/09/2021
Date data sharing statement initially provided
27/09/2021
Date results information initially provided
27/09/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Consequences of COVID-19 on the respiratory, coagulation, immune and endocrine system and association with bacterial infections among patients treated in the intensive care unit.
Scientific title
Assessment of the impact of SARS-CoV-2 infection on the respiratory, coagulation, immune and endocrine system and the frequency of bacterial infections in patients hospitalized in the intensive care unit.
Secondary ID [1] 304998 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 323157 0
Respiratory infection 323158 0
Coagulation disorders 323159 0
Renin-angiotensin-aldosterone system dysfunction 323346 0
Acute kidney injury 323347 0
Condition category
Condition code
Infection 320739 320739 0 0
Other infectious diseases
Respiratory 320740 320740 0 0
Other respiratory disorders / diseases
Blood 320742 320742 0 0
Clotting disorders
Metabolic and Endocrine 320743 320743 0 0
Metabolic disorders
Metabolic and Endocrine 320744 320744 0 0
Other endocrine disorders
Inflammatory and Immune System 320745 320745 0 0
Other inflammatory or immune system disorders
Renal and Urogenital 320918 320918 0 0
Kidney disease

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
28
Target follow-up type
Days
Description of intervention(s) / exposure
The study aimed to determine the correlation between the infection of SARS-CoV-2 and the occurrence of respiratory, coagulation, immune and endocrine system disorders. The study will be a retrospective observational design; therefore, no active involvement by participants is required. The study will include adult patients hospitalized for SARS-CoV-2 infection in the Intensive Care Unit of the 4th Military Hospital of Wroclaw in Poland. Audit of medical records of adult patients hospitalized for SARS-CoV-2 infection in the Intensive Care Unit of the 4th Military Hospital of Wroclaw in Poland between June 1st, 2021 to July 31st, 2021.

Demographics, blood type, and mechanical ventilation parameters will be analyzed during the study. Additionally, coagulation tests, blood morphology, markers of kidney injury, thromboelastometry, inflammatory markers such as CRP and PCT (procalcitonin) will be evaluated. Kidney function and the rate of thromboembolic complications will be assessed. The frequency of bacterial and fungal co-infections will be recorded. Additionally, information on chronic diseases (diabetes, hypertension, kidney failure, and nicotine addiction) and medications will be collected.
Intervention code [1] 321393 0
Diagnosis / Prognosis
Intervention code [2] 321394 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328554 0
Mortality in patients with COVID-19 hospitalized in ICU using medical records and medical documentation
Timepoint [1] 328554 0
From the time of ICU admission to discharge from ICU
Primary outcome [2] 328555 0
The course of infections in patients with COVID-19 using medical records and medical documentation (time of symptoms and markers of infection: white cells count, C-reactive protein, procalcitonin, culture results, and body temperature measurements will be assessed as a composite outcome)
Timepoint [2] 328555 0
Monitored continuously during ICU admission
Primary outcome [3] 328556 0
The course of coagulation disorders in patients with COVID-19 using medical records and medical documentation (prothrombin time, activated partial thromboplastin time, international normalized ratio, platelet count, thrombin time, antithrombin III, thromboelastography, level of fibrinogen, d-dimer measurements will be assessed as a composite outcome)
Timepoint [3] 328556 0
Monitored continuously during ICU admission
Secondary outcome [1] 399407 0
The course of acute kidney injury (AKI) in patients with COVID-19 using medical records and medical documentation (inflammatory and renal parameters)
Timepoint [1] 399407 0
Monitored continuously during ICU admission
Secondary outcome [2] 399408 0
The course of acute respiratory distress syndrome (ARDS) in patients with COVID-19 using medical records and medical documentation (chest x-ray findings, oxygen saturation, ventilation parameters, ventilation mode)
Timepoint [2] 399408 0
Monitored continuously during ICU admission
Secondary outcome [3] 399409 0
Assessment of renin-angiotensin-aldosterone system (RAAS) abnormalities in patients with COVID-19 using medical records and medical documentation (aldosterone levels)
Timepoint [3] 399409 0
Monitored continuously during ICU admission
Secondary outcome [4] 399410 0
Prevalence of thromboembolic complications in patients with COVID-19 using medical records and medical documentation
Timepoint [4] 399410 0
Monitored continuously during ICU admission
Secondary outcome [5] 400036 0
Assessment of body mass index in patients with COVID-19 using medical records and medical documentation (height determined by stadiometer, and weight determined using balance scales)
Timepoint [5] 400036 0
Assessed systematically during ICU stay
Secondary outcome [6] 400037 0
Assessment of the effectiveness of the prone position in patients with COVID-19 using medical records and medical documentation
Timepoint [6] 400037 0
Assessed systematically during ICU stay
Secondary outcome [7] 400038 0
Assessment of medications administration in patients with COVID-19 using medical records and medical documentation (pharmacological treatment card)
Timepoint [7] 400038 0
Assessed systematically during ICU stay
Secondary outcome [8] 400206 0
Clinical assessment using Sequential Organ Failure Assessment (SOFA) scale to assess organ dysfunction in six organ systems such as respiratory, coagulatory, liver, cardiovascular, renal, and neurologic (assessed as a composite secondary outcome)
Timepoint [8] 400206 0
Assessed only once after ICU admission
Secondary outcome [9] 400207 0
Clinical assessment using Acute Physiology and Chronic Health Evaluation II (APACHE II) scale to quantify disease severity and to stratify the hospital mortality risk
Timepoint [9] 400207 0
Assessed systematically during ICU stay

Eligibility
Key inclusion criteria
1. Aged between 18 and 90 years
2. Patients with confirmed COVID-19 hospitalized in the ICU
3. The obtained consent to participate in the study
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Analyses will be performed using Statistica v.10 (TIBCO Software Inc., USA). Continuously distributed data will be tested for normality using the Shapiro-Wilk and Kolmogorov-Smirnov tests. The critical significance level will be assumed at p<0.05. Qualitative variables (infection type) will be presented as counts (n) and proportions (%). Pearson's chi-square test of independence will be used to assess the association between infection type and 28-day survival. Quantitative variables will be presented in tables as mean values (M) and standard deviations (SD). The significance of differences between mean parameter levels in groups differing in 28-day survival will be verified using Student's t-test. Kaplan-Meier method will be used to evaluate overall survival (OS). The log-rank test will be used to compare the survival curves of the patient group. The results will be considered statistically significant when the p-values were lower than 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/06/2021
Date of last participant enrolment
Anticipated
Actual
31/07/2021
Date of last data collection
Anticipated
Actual
31/07/2021
Sample size
Target
140
Accrual to date
Final
132
Recruitment outside Australia
Country [1] 24034 0
Poland
State/province [1] 24034 0
Lower Silesia

Funding & Sponsors
Funding source category [1] 309381 0
Hospital
Name [1] 309381 0
4th Military Hospital of Wroclaw, Poland
Country [1] 309381 0
Poland
Primary sponsor type
Individual
Name
Patrycja Lesnik, MD, PhD
Address
Department of Anesthesiology and Intensive Care, 4th Military Hospital of Wroclaw, Weigla 5, 50-981 Wroclaw, Poland
Country
Poland
Secondary sponsor category [1] 310357 0
Individual
Name [1] 310357 0
Jaroslaw Janc, MD, PhD
Address [1] 310357 0
Department of Anesthesiology and Intensive Care, 4th Military Hospital of Wroclaw, Weigla 5, 50-981 Wroclaw, Poland
Country [1] 310357 0
Poland
Other collaborator category [1] 281934 0
Individual
Name [1] 281934 0
Lidia Lysenko, MD, PhD
Address [1] 281934 0
Department of Anaesthesiology and Intensive Therapy, Wroclaw Medical University, Borowska 213, 50-529 Wroclaw, Poland
Country [1] 281934 0
Poland
Other collaborator category [2] 281935 0
Individual
Name [2] 281935 0
Michal Suchanski, MD
Address [2] 281935 0
Department of Anesthesiology and Intensive Care, 4th Military Hospital of Wroclaw, Weigla 5, 50-981 Wroclaw, Poland
Country [2] 281935 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309196 0
Bioethics Committee at The Military Medical Chamber in Warsaw, Poland
Ethics committee address [1] 309196 0
Jelinka 48, 01-646 Warsaw, Poland
Ethics committee country [1] 309196 0
Poland
Date submitted for ethics approval [1] 309196 0
07/05/2021
Approval date [1] 309196 0
21/05/2021
Ethics approval number [1] 309196 0
3/21

Summary
Brief summary
Assessment of the impact of SARS-CoV-2 infection on the respiratory, coagulation, immune and endocrine system and the frequency of bacterial infections in patients hospitalized in the intensive care unit. This is a retrospective and cross-sectional study among patients who were treated in ICU for COVID-19.

Clinical records and medical documentation obtained during hospitalization of patients in the Department of Anaesthesiology and Intensive Care in the 4th Military Clinical Hospital in Wroclaw in the period from June 1st, 2021 to July 31st, 2021 due to COVID-19 will be evaluated. Apart from the assessment of Sequential Organ Failure Assessment (SOFA), Acute Physiology and Chronic Health Evaluation II (APACHE II), and Simplified Acute Physiology Score II (SAPS II) scales, the selected parameters of the coagulation, hematopoietic, endocrine systems as well as inflammatory and renal parameters will be analyzed. These examinations were taken routinely every day. Ventilation parameters and modes according to the type of ARDS (type H or L) and the effectiveness of the prone position was evaluated. In addition, the study is designed to assess the incidence of bacterial infections, particularly with multi-drug resistant strains, and fungal infections. Medications administered and the incidence of thromboembolic complications were recorded. Additionally, demographic data, BMI, blood group, and the presence of co-morbidities and actual medications will be studied.

Symptomatic respiratory distress in COVID-19 often leads to the development of acute respiratory distress syndrome (ARDS) and the need for mechanical ventilation. In addition, bacterial superinfection occurs in patients with immunological disorders and in the course of steroid therapy. Increasingly, co-infections with multidrug-resistant strains are observed, which further worsen prognosis. Thus, patients infected with SARS-CoV-2 have an excessive susceptibility to activation of the coagulation system, hypertension, insulin resistance, alveolar edema, and ARDS. We would like to ensure that participants received interventions regardless of their involvement in the study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113310 0
Dr Patrycja Lesnik, MD, PhD
Address 113310 0
Department of Anesthesiology and Intensive Care, 4th Military Hospital of Wroclaw, Weigla 5, 50-981 Wroclaw, Poland
Country 113310 0
Poland
Phone 113310 0
+48 71 712 89 39
Fax 113310 0
Email 113310 0
[email protected]
Contact person for public queries
Name 113311 0
Dr Patrycja Lesnik, MD, PhD
Address 113311 0
Department of Anesthesiology and Intensive Care, 4th Military Hospital of Wroclaw, Weigla 5, 50-981 Wroclaw, Poland
Country 113311 0
Poland
Phone 113311 0
+48 71 712 89 39
Fax 113311 0
Email 113311 0
[email protected]
Contact person for scientific queries
Name 113312 0
Dr Patrycja Lesnik, MD, PhD
Address 113312 0
Department of Anesthesiology and Intensive Care, 4th Military Hospital of Wroclaw, Weigla 5, 50-981 Wroclaw, Poland
Country 113312 0
Poland
Phone 113312 0
+48 71 712 89 39
Fax 113312 0
Email 113312 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12805Ethical approval    382563-(Uploaded-10-08-2021-08-56-28)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.