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临床试验/NCT04537559
NCT04537559Unknown不适用

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)

University Hospital, Geneva1 个研究点 分布在 1 个国家目标入组 240,000 人开始时间: 2019年3月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
240,000
试验地点
1
主要终点
Intra-hospital mortality

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Intra-hospital mortality

时间窗: Assessed at the discharge date, up to 3 months after admission

death during hospitalization of each patient

composite outcome (worsening during hospitalization)

时间窗: 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

次要结局

  • Hemoglobin serum level(At the acute care admission)
  • D-Dimers serum level(At the acute care admission)
  • glucose serum level(At the acute care admission)
  • potassium serum level(At the acute care admission)
  • creatinine serum level(At the acute care admission)
  • Gamma glutamyl transpeptidase. serum level(At the acute care admission)
  • Arterial pCO2 (carbon dioxide partial pressure)(At the acute care admission)
  • Arterial HCO3 (bicarbonate)(At the acute care admission)
  • Arterial lactate(At the acute care admission)
  • Arterial pressure(At the acute care admission)
  • temperature(At the acute care admission)
  • specific gravity outcomes for patients with pneumonia : CURB 65 scale (Confusion, Urea, Respiratory rate, Blood pressure, Age [>65])(At the acute care admission)
  • oxygen saturation(At the acute care admission)
  • length of stay(At the discharge date of hospitalization, up to 3 months after admission)
  • Thrombocytes serum level(At the acute care admission)
  • INR (International Normalized Ratio)(At the acute care admission)
  • C-reactive protein serum level (CRP)(At the acute care admission)
  • folate serum level(At the acute care admission)
  • 25-hydroxy vitamin D (D2 + D3) serum level(At the acute care admission)
  • Alkaline phosphatases serum level(At the acute care admission)
  • Total bilirubin serum level(At the acute care admission)
  • mortality rate by pathology at 3 months(within the 3 months after the admission date)
  • specific gravity outcomes for patients with cardiac Failure : Weight variation(At the acute care admission)
  • Leukocytes serum level(At the acute care admission)
  • Lymphocytes serum level(At the acute care admission)
  • glycated hemoglobin serum level (HbA1C)(At the acute care admission)
  • chlorides serum level(At the acute care admission)
  • Ultra sensitive Troponin T serum level(At the acute care admission)
  • TSH serum level(At the acute care admission)
  • Arterial pH(At the acute care admission)
  • respiratory rates(At the acute care admission)
  • specific scales : VAS of pain(At the acute care admission)
  • cyanocobalamin serum level(At the acute care admission)
  • Pathologies leading to hospitalization(At the discharge date of hospitalization, up to 3 months after admission)
  • overall mortality at 3 months (90 days)(within the 3 months after the admission date)
  • rate of transfer to intermediate or intensive care(At the discharge date, up to 3 months after admission)
  • rate of transfer to rehabilitation care(At the discharge date of acute care, up to 3 months after admission)
  • Quick serum level(At the acute care admission)
  • fibrinogen serum level(At the acute care admission)
  • Phosphates serum level(At the acute care admission)
  • corrected calcium serum level(At the acute care admission)
  • eGFR (CKD-EPI) serum level(At the acute care admission)
  • proBNP (Brain Natriuretic Peptid) serum level(At the acute care admission)
  • Potentially avoidable readmission rate(During the 30 days after the patient's discharge)
  • specific gravity outcomes for patients with cardiac Failure or lung disease(At the acute care admission)
  • Patient questionnaire(At the discharge date of hospitalization, up to 3 months after admission)
  • specific gravity outcomes for patients with cardiac Failure : KILLIP class(At the acute care admission)
  • Polynuclear neutrophils serum level(At the acute care admission)
  • PTT serum level (partial Thromboplastin time)(At the acute care admission)
  • sodium serum level(At the acute care admission)
  • calculated osmolality serum level(At the acute care admission)
  • urea serum level(At the acute care admission)
  • albumin serum level(At the acute care admission)
  • prealbumin serum level(At the acute care admission)
  • ASAT (aspartate transaminase) serum level(At the acute care admission)
  • ALAT (alanine aminotransferase) serum level(At the acute care admission)
  • peak flow(At the acute care admission)
  • specific scales : MNA(At the acute care admission)
  • specific scales : NRS(At the acute care admission)
  • ferritin serum level(At the acute care admission)
  • protein serum level(At the acute care admission)
  • cardiac rates(At the acute care admission)
  • specific scales : SOFA score(At the acute care admission)
  • Arterial pO2 (oxygen partial pressure)(At the acute care admission)
  • specific scales : FIM(At the acute care admission)
  • serum or urine positive bacteriologic sample(At the acute care admission or during hospitalization)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jerome Stirnemann

Dr

University Hospital, Geneva

研究点 (1)

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