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Impact of COVID-19 Outbreak on Non-COVID-19 Patients

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)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04537559
Acronym
NoCOVImpact
Enrollment
240000
Registered
2020-09-03
Start date
2019-03-01
Completion date
2023-02-28
Last updated
2022-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Keywords

COVID-19 Outbreak, non COVID-19

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.

Interventions

None listed

Sponsors

La Tour Hospital
CollaboratorOTHER
University Hospital, Geneva
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Intra-hospital mortalityAssessed at the discharge date, up to 3 months after admissiondeath during hospitalization of each patient
composite outcome (worsening during hospitalization)At the discharge date of hospitalization, up to 3 months after admissionintra-hospital mortality and / or transfer to intensive care and / or transfer to intermediate care during hospitalization

Secondary

MeasureTime frameDescription
TSH serum levelAt the acute care admissionmU / l
Arterial pHAt the acute care admissionNo unit
Arterial pCO2 (carbon dioxide partial pressure)At the acute care admissionkPa
Arterial pO2 (oxygen partial pressure)At the acute care admissionkPa
Arterial lactateAt the acute care admissionmmol / l
Arterial HCO3 (bicarbonate)At the acute care admissionmmol / l
protein serum levelAt the acute care admissiong / l
Pathologies leading to hospitalizationAt the discharge date of hospitalization, up to 3 months after admissionPrimary and secondary diagnosis during hospitalization (CIM10 codes)
overall mortality at 3 months (90 days)within the 3 months after the admission dateintra or extra hospital mortality : death occuring during hospitalization or after
Potentially avoidable readmission rateDuring the 30 days after the patient's dischargePotentially avoidable readmission according to SQLape algorithm (http://www.sqlape.com/READMISSIONS.htm)
mortality rate by pathology at 3 monthswithin the 3 months after the admission datemortality for each top 10 of pathologies (intra or extra hospital mortality for each pathology)
length of stayAt the discharge date of hospitalization, up to 3 months after admissionHospital length of stay (Time between admission date and discharge date)
rate of transfer to intermediate or intensive careAt the discharge date, up to 3 months after admissionNumber of patients with transfer to intensive or intermediate care during hospitalization
rate of transfer to rehabilitation careAt the discharge date of acute care, up to 3 months after admissionNumber of patients with rehabilitation transfer during hospitalization
specific gravity outcomes for patients with pneumonia : CURB 65 scale (Confusion, Urea, Respiratory rate, Blood pressure, Age [>65])At the acute care admissionCURB65 scale: min-max 0 to 5 points \[5 points : worse outcome\]
specific gravity outcomes for patients with cardiac Failure : KILLIP classAt the acute care admissionKILLIP 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.
specific gravity outcomes for patients with cardiac Failure : Weight variationAt the acute care admissionWeight variation : variation of weight at the admission compared to the basis weight
specific gravity outcomes for patients with cardiac Failure or lung diseaseAt the acute care admissionFIO2 (% O2 prescribed): Fraction of inspired oxygen
Leukocytes serum levelAt the acute care admissionGiga / litre
Polynuclear neutrophils serum levelAt the acute care admissionGiga / litre
Lymphocytes serum levelAt the acute care admissionGiga / litre
Hemoglobin serum levelAt the acute care admissiongram/litre
Thrombocytes serum levelAt the acute care admissionGiga / litre
Quick serum levelAt the acute care admissionin %
INR (International Normalized Ratio)At the acute care admissionNo unit
fibrinogen serum levelAt the acute care admissiongram/litre
PTT serum level (partial Thromboplastin time)At the acute care admissionin second
D-Dimers serum levelAt the acute care admissionng / ml
glucose serum levelAt the acute care admissionmmol / litre
glycated hemoglobin serum level (HbA1C)At the acute care admissionin %
C-reactive protein serum level (CRP)At the acute care admissionmg / litre
sodium serum levelAt the acute care admissionmmol / l
potassium serum levelAt the acute care admissionmmol / l
chlorides serum levelAt the acute care admissionmmol / l
calculated osmolality serum levelAt the acute care admissionmOsm / kg
Phosphates serum levelAt the acute care admissionmmol / l
corrected calcium serum levelAt the acute care admissionmmol / l
urea serum levelAt the acute care admissionmmol / l
creatinine serum levelAt the acute care admissionµmol / l
eGFR (CKD-EPI) serum levelAt the acute care admissionml / min / 1.73m2
albumin serum levelAt the acute care admissiong / l
prealbumin serum levelAt the acute care admissionmg / l
cyanocobalamin serum levelAt the acute care admissionpmol / l
folate serum levelAt the acute care admissionnmol / l
25-hydroxy vitamin D (D2 + D3) serum levelAt the acute care admissionnmol / l
proBNP (Brain Natriuretic Peptid) serum levelAt the acute care admissionng / l
Ultra sensitive Troponin T serum levelAt the acute care admissionng / l
ASAT (aspartate transaminase) serum levelAt the acute care admissionU / l
ALAT (alanine aminotransferase) serum levelAt the acute care admissionU / l
Alkaline phosphatases serum levelAt the acute care admissionU / l
Gamma glutamyl transpeptidase. serum levelAt the acute care admissionU / l
Arterial pressureAt the acute care admissionArterial pression (min-max), in mmHg
cardiac ratesAt the acute care admissionBat/mn
respiratory ratesAt the acute care admission/mn
temperatureAt the acute care admissionCelsius degrees
oxygen saturationAt the acute care admissionPercutaneous oxygen saturation (in %)
peak flowAt the acute care admissionL/mn
Total bilirubin serum levelAt the acute care admissionµmol / l
specific scales : FIMAt the acute care admissionFunctional Independence Measure (min-max : 18 \[worse outcome\]) to 126)
specific scales : SOFA scoreAt the acute care admissionSequential Organ Failure Assessment Score (min-max : 0 to 24 \[worse outcome\])
specific scales : MNAAt the acute care admissionMini Nutritional Assessment (min-max : 0 \[worse outcome\] to 14)
specific scales : NRSAt the acute care admissionNutrition Risk Screening (min-max : 0 to 12 \[worse outcome\])
serum or urine positive bacteriologic sampleAt the acute care admission or during hospitalizationnumber of positive hemoculture or urinary cultures
Patient questionnaireAt the discharge date of hospitalization, up to 3 months after admissionQuestionnaire 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 scales : VAS of painAt the acute care admissionVisual analog Pain scale (min-max : 1 to 10 \[worse outcome\])
ferritin serum levelAt the acute care admissionµg / l

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026