Impact of COVID-19 Outbreak on Non-COVID-19 Patients
- Conditions
- COVID-19
- Registration Number
- NCT04537559
- Lead Sponsor
- University Hospital, Geneva
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 240000
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Intra-hospital mortality Assessed at the discharge date, up to 3 months after admission death during hospitalization of each patient
composite outcome (worsening during hospitalization) At the discharge date of hospitalization, up to 3 months after admission intra-hospital mortality and / or transfer to intensive care and / or transfer to intermediate care during hospitalization
- Secondary Outcome Measures
Name Time Method Pathologies leading to hospitalization At the discharge date of hospitalization, up to 3 months after admission Primary and secondary diagnosis during hospitalization (CIM10 codes)
overall mortality at 3 months (90 days) within the 3 months after the admission date intra or extra hospital mortality : death occuring during hospitalization or after
rate of transfer to intermediate or intensive care At the discharge date, up to 3 months after admission Number of patients with transfer to intensive or intermediate care during hospitalization
rate of transfer to rehabilitation care At the discharge date of acute care, up to 3 months after admission Number of patients with rehabilitation transfer during hospitalization
Quick serum level At the acute care admission in %
fibrinogen serum level At the acute care admission gram/litre
Phosphates serum level At the acute care admission mmol / l
corrected calcium serum level At the acute care admission mmol / l
specific gravity outcomes for patients with pneumonia : CURB 65 scale (Confusion, Urea, Respiratory rate, Blood pressure, Age [>65]) At the acute care admission CURB65 scale: min-max 0 to 5 points \[5 points : worse outcome\]
length of stay At the discharge date of hospitalization, up to 3 months after admission Hospital length of stay (Time between admission date and discharge date)
Thrombocytes serum level At the acute care admission Giga / litre
INR (International Normalized Ratio) At the acute care admission No unit
C-reactive protein serum level (CRP) At the acute care admission mg / litre
folate serum level At the acute care admission nmol / l
25-hydroxy vitamin D (D2 + D3) serum level At the acute care admission nmol / l
Alkaline phosphatases serum level At the acute care admission U / l
Total bilirubin serum level At the acute care admission µmol / l
mortality rate by pathology at 3 months within the 3 months after the admission date mortality for each top 10 of pathologies (intra or extra hospital mortality for each pathology)
specific gravity outcomes for patients with cardiac Failure : Weight variation At the acute care admission Weight variation : variation of weight at the admission compared to the basis weight
Leukocytes serum level At the acute care admission Giga / litre
Lymphocytes serum level At the acute care admission Giga / litre
glycated hemoglobin serum level (HbA1C) At the acute care admission in %
chlorides serum level At the acute care admission mmol / l
Ultra sensitive Troponin T serum level At the acute care admission ng / l
TSH serum level At the acute care admission mU / l
Arterial pH At the acute care admission No unit
respiratory rates At the acute care admission /mn
specific scales : VAS of pain At the acute care admission Visual analog Pain scale (min-max : 1 to 10 \[worse outcome\])
eGFR (CKD-EPI) serum level At the acute care admission ml / min / 1.73m2
proBNP (Brain Natriuretic Peptid) serum level At the acute care admission ng / l
Potentially avoidable readmission rate During the 30 days after the patient's discharge Potentially avoidable readmission according to SQLape algorithm (http://www.sqlape.com/READMISSIONS.htm)
specific gravity outcomes for patients with cardiac Failure or lung disease At the acute care admission FIO2 (% O2 prescribed): Fraction of inspired oxygen
Hemoglobin serum level At the acute care admission gram/litre
D-Dimers serum level At the acute care admission ng / ml
glucose serum level At the acute care admission mmol / litre
potassium serum level At the acute care admission mmol / l
creatinine serum level At the acute care admission µmol / l
Gamma glutamyl transpeptidase. serum level At the acute care admission U / l
Arterial pCO2 (carbon dioxide partial pressure) At the acute care admission kPa
Arterial HCO3 (bicarbonate) At the acute care admission mmol / l
Patient questionnaire At the discharge date of hospitalization, up to 3 months after admission Questionnaire asking each patient if they had difficulty seeing a doctor before their hospitalization and if they delayed their hospitalization due to the COVID-19 crisis.
specific gravity outcomes for patients with cardiac Failure : KILLIP class At the acute care admission KILLIP class (class 1 to 4) \[class 4 : worse outcome\]. The KILLIP classification is a system used in individuals with an acute myocardial infarction (heart attack), taking into account physical examination and the development of heart failure in order to predict and stratify their risk of mortality.
Polynuclear neutrophils serum level At the acute care admission Giga / litre
PTT serum level (partial Thromboplastin time) At the acute care admission in second
sodium serum level At the acute care admission mmol / l
calculated osmolality serum level At the acute care admission mOsm / kg
urea serum level At the acute care admission mmol / l
albumin serum level At the acute care admission g / l
prealbumin serum level At the acute care admission mg / l
ASAT (aspartate transaminase) serum level At the acute care admission U / l
ALAT (alanine aminotransferase) serum level At the acute care admission U / l
peak flow At the acute care admission L/mn
specific scales : MNA At the acute care admission Mini Nutritional Assessment (min-max : 0 \[worse outcome\] to 14)
specific scales : NRS At the acute care admission Nutrition Risk Screening (min-max : 0 to 12 \[worse outcome\])
protein serum level At the acute care admission g / l
cardiac rates At the acute care admission Bat/mn
specific scales : SOFA score At the acute care admission Sequential Organ Failure Assessment Score (min-max : 0 to 24 \[worse outcome\])
Arterial pO2 (oxygen partial pressure) At the acute care admission kPa
Arterial lactate At the acute care admission mmol / l
Arterial pressure At the acute care admission Arterial pression (min-max), in mmHg
temperature At the acute care admission Celsius degrees
specific scales : FIM At the acute care admission Functional Independence Measure (min-max : 18 \[worse outcome\]) to 126)
serum or urine positive bacteriologic sample At the acute care admission or during hospitalization number of positive hemoculture or urinary cultures
oxygen saturation At the acute care admission Percutaneous oxygen saturation (in %)
cyanocobalamin serum level At the acute care admission pmol / l
ferritin serum level At the acute care admission µg / l
Trial Locations
- Locations (1)
Geneva University Hospital
🇨🇭Geneva, Canton De Genève, Switzerland