Clinical trial NCT04537559: Impact of COVID-19 Outbreak on Non-COVID-19 Patients
Official title: Impact of the COVID-19 Pandemic on the Morbidity and Mortality of Non-COVID-19 Patients Hospitalized Around the Epidemic Peak in the Geneva Area (Switzerland) (No COVID Impact)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Keywords: COVID-19 Outbreak
non COVID-19
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: La Tour Hospital
First posted: 2020-09-03
Enrollment: 240000
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients hospitalized in Geneva hospital or clinic from the 1st march 2019 to 28 february 2023.

Brief summary: The Geneva Canton organized the health crisis of the COVID-19 epidemic around the care of COVID patients at the University Hospital (HUG), by moving the care of non-COVID patients to private hospitals of the canton. The COVID epidemic appears to have been associated with a decrease in consultations and care for non-COVID patients. An excess of morbidity and mortality (non-COVID) would be possible during or after the epidemic in connection with this "under-medicalization" of non-COVID patients.

The aim of this study is to measure and analyze the impact on the morbidity and mortality of inpatients during and after the COVID-19 epidemic in the adult inpatient wards of HUG and township hospitals / clinics.

Detailed description: The analysis of the various results will be carried out on all HUGs and on the various hospitals / clinics in the canton.

A survival analysis for the outcome of death or rehospitalization will be performed, with a comparison according to each period.

After epidemy evolution, finally, the outcomes will be compared between periods pre-COVID (from 01 march 2019 to 28 february 2020) versus per-COVID (01 march 2020 to 28 february 2022), and versus post-COVID (01 march 2022 to 28 february 2023). And comparaison would be performed between periods during the wave (per-wave) versus periods inter-wave.

A description will be made in number (%) for numerical data and in median (IQR) for quantitative data. Univariate comparisons between the different periods will be carried out by statistical tests, parametric or not, adapted according to the data (Chi2 or Fisher's test for qualitative data, Student's test or Mann-Whitney-Wilcoxon for quantitative data). Statistical significance will be retained in the event of p \<0.05.

Multivariate analysis will be performed by logistic regression for the main outcome and by cox model for survival analysis. Different variables will be included in the models, including data on gender, age and comorbidity, as well as any variable having a difference with p \<0.2 in univariate analysis.

Secondary analyzes will be carried out by pathology (as the main diagnosis) according to the specific results defined for each situation. In retrospective analysis, these specific data will be relatively limited on the HUG area of full analysis brings together around total of 240,000 hospital stays. The main outcome data will be complete with no missing data. On the other hand, since this is retrospective data, it is possible that some important variables are missing. In this case, other patient data with missing data will not be included in the multivariate analyzes. In the event of missing data greater than 10%, a second sensitivity analysis may be performed after replacing the missing data with a multiple imputation method.

Eligibility criteria: Inclusion Criteria:

* Patient hospitalized in an adult department
* During the pre-period-COVID-19 period, the per-COVID-19 or the post-COVID-19 periods ie from the 1st march 2019 to 28 february 2023.

Exclusion Criteria:

* Patients who have been hospitalized for COVID-19 infection
* Patients hospitalized in the Department of Adolescent Woman and Child, Department of Psychiatry or Intensive Care Department during the same periods.

Primary outcomes:
measure: Intra-hospital mortality
timeFrame: Assessed at the discharge date, up to 3 months after admission
measure: composite outcome (worsening during hospitalization)
timeFrame: At the discharge date of hospitalization, up to 3 months after admission
Secondary outcomes:
measure: Pathologies leading to hospitalization
timeFrame: At the discharge date of hospitalization, up to 3 months after admission
measure: overall mortality at 3 months (90 days)
timeFrame: within the 3 months after the admission date
measure: Potentially avoidable readmission rate
timeFrame: During the 30 days after the patient's discharge
measure: mortality rate by pathology at 3 months
timeFrame: within the 3 months after the admission date
measure: length of stay
timeFrame: At the discharge date of hospitalization, up to 3 months after admission
measure: rate of transfer to intermediate or intensive care
timeFrame: At the discharge date, up to 3 months after admission
measure: rate of transfer to rehabilitation care
timeFrame: At the discharge date of acute care, up to 3 months after admission
measure: specific gravity outcomes for patients with pneumonia : CURB 65 scale (Confusion, Urea, Respiratory rate, Blood pressure, Age [>65])
timeFrame: At the acute care admission
measure: specific gravity outcomes for patients with cardiac Failure : KILLIP class
timeFrame: At the acute care admission
measure: specific gravity outcomes for patients with cardiac Failure : Weight variation
timeFrame: At the acute care admission
measure: specific gravity outcomes for patients with cardiac Failure or lung disease
timeFrame: At the acute care admission
measure: Leukocytes serum level
timeFrame: At the acute care admission
measure: Polynuclear neutrophils serum level
timeFrame: At the acute care admission
measure: Lymphocytes serum level
timeFrame: At the acute care admission
measure: Hemoglobin serum level
timeFrame: At the acute care admission
measure: Thrombocytes serum level
timeFrame: At the acute care admission
measure: Quick serum level
timeFrame: At the acute care admission
measure: INR (International Normalized Ratio)
timeFrame: At the acute care admission
measure: fibrinogen serum level
timeFrame: At the acute care admission
measure: PTT serum level (partial Thromboplastin time)
timeFrame: At the acute care admission
measure: D-Dimers serum level
timeFrame: At the acute care admission
measure: glucose serum level
timeFrame: At the acute care admission
measure: glycated hemoglobin serum level (HbA1C)
timeFrame: At the acute care admission
measure: C-reactive protein serum level (CRP)
timeFrame: At the acute care admission
measure: sodium serum level
timeFrame: At the acute care admission
measure: potassium serum level
timeFrame: At the acute care admission
measure: chlorides serum level
timeFrame: At the acute care admission
measure: calculated osmolality serum level
timeFrame: At the acute care admission
measure: Phosphates serum level
timeFrame: At the acute care admission
measure: corrected calcium serum level
timeFrame: At the acute care admission
measure: urea serum level
timeFrame: At the acute care admission
measure: creatinine serum level
timeFrame: At the acute care admission
measure: eGFR (CKD-EPI) serum level
timeFrame: At the acute care admission
measure: albumin serum level
timeFrame: At the acute care admission
measure: prealbumin serum level
timeFrame: At the acute care admission
measure: cyanocobalamin serum level
timeFrame: At the acute care admission
measure: folate serum level
timeFrame: At the acute care admission
measure: 25-hydroxy vitamin D (D2 + D3) serum level
timeFrame: At the acute care admission
measure: proBNP (Brain Natriuretic Peptid) serum level
timeFrame: At the acute care admission
measure: Ultra sensitive Troponin T serum level
timeFrame: At the acute care admission
measure: ASAT (aspartate transaminase) serum level
timeFrame: At the acute care admission
measure: ALAT (alanine aminotransferase) serum level
timeFrame: At the acute care admission
measure: Alkaline phosphatases serum level
timeFrame: At the acute care admission
measure: Gamma glutamyl transpeptidase. serum level
timeFrame: At the acute care admission
measure: Total bilirubin serum level
timeFrame: At the acute care admission
measure: ferritin serum level
timeFrame: At the acute care admission
measure: TSH serum level
timeFrame: At the acute care admission
measure: Arterial pH
timeFrame: At the acute care admission
measure: Arterial pCO2 (carbon dioxide partial pressure)
timeFrame: At the acute care admission
measure: Arterial pO2 (oxygen partial pressure)
timeFrame: At the acute care admission
measure: Arterial lactate
timeFrame: At the acute care admission
measure: Arterial HCO3 (bicarbonate)
timeFrame: At the acute care admission
measure: protein serum level
timeFrame: At the acute care admission
measure: Arterial pressure
timeFrame: At the acute care admission
measure: cardiac rates
timeFrame: At the acute care admission
measure: respiratory rates
timeFrame: At the acute care admission
measure: temperature
timeFrame: At the acute care admission
measure: oxygen saturation
timeFrame: At the acute care admission
measure: peak flow
timeFrame: At the acute care admission
measure: specific scales : VAS of pain
timeFrame: At the acute care admission
measure: specific scales : FIM
timeFrame: At the acute care admission
measure: specific scales : SOFA score
timeFrame: At the acute care admission
measure: specific scales : MNA
timeFrame: At the acute care admission
measure: specific scales : NRS
timeFrame: At the acute care admission
measure: serum or urine positive bacteriologic sample
timeFrame: At the acute care admission or during hospitalization
measure: Patient questionnaire
timeFrame: At the discharge date of hospitalization, up to 3 months after admission
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospital
state: Canton De Genève
Study officials:
affiliation: University Hospital, Geneva
name: Jerome Stirnemann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Welt FGP, Shah PB, Aronow HD, Bortnick AE, Henry TD, Sherwood MW, Young MN, Davidson LJ, Kadavath S, Mahmud E, Kirtane AJ; American College of Cardiology's Interventional Council and the Society for Cardiovascular Angiography and Interventions. Catheterization Laboratory Considerations During the Coronavirus (COVID-19) Pandemic: From the ACC's Interventional Council and SCAI. J Am Coll Cardiol. 2020 May 12;75(18):2372-2375. doi: 10.1016/j.jacc.2020.03.021. Epub 2020 Mar 19. No abstract available.
citation: Garcia S, Albaghdadi MS, Meraj PM, Schmidt C, Garberich R, Jaffer FA, Dixon S, Rade JJ, Tannenbaum M, Chambers J, Huang PP, Henry TD. Reduction in ST-Segment Elevation Cardiac Catheterization Laboratory Activations in the United States During COVID-19 Pandemic. J Am Coll Cardiol. 2020 Jun 9;75(22):2871-2872. doi: 10.1016/j.jacc.2020.04.011. Epub 2020 Apr 10. No abstract available.
citation: Roffi M, Guagliumi G, Ibanez B. The Obstacle Course of Reperfusion for ST-Segment-Elevation Myocardial Infarction in the COVID-19 Pandemic. Circulation. 2020 Jun 16;141(24):1951-1953. doi: 10.1161/CIRCULATIONAHA.120.047523. Epub 2020 Apr 21. No abstract available.
citation: Rosenbaum L. The Untold Toll - The Pandemic's Effects on Patients without Covid-19. N Engl J Med. 2020 Jun 11;382(24):2368-2371. doi: 10.1056/NEJMms2009984. Epub 2020 Apr 17. No abstract available.
citation: Killip T 3rd, Kimball JT. Treatment of myocardial infarction in a coronary care unit. A two year experience with 250 patients. Am J Cardiol. 1967 Oct;20(4):457-64. doi: 10.1016/0002-9149(67)90023-9. No abstract available.