Covid-19 Associated Nephritis as Early Predictor for Complicated Course of Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 223
- 试验地点
- 1
- 主要终点
- Time to Disease-Aggravation
研究概览
简要总结
This non-interventional, observational study retrospectively (and in parts prospectively) investigates, if a Covid-19 associated Nephritis, diagnosed by Urine-dipstick and further Urine-analyses on addmission, can help to predict later complications, adverse outcomes and later need for ICU-capacity in Covid-19 patients as well as can guide preventive strategies.
详细描述
Parameters predicting risks for Covid-19 patients are urgently sought. The current study investigates, if Covid-19 associated nephritis indicating systemic cappillary leak syndrome/severe nephrotic syndrome could be the major driver for complications, predictor for respiratory failure and later need for ICU, and death.
This study intends to generate an algorithm for University hospitals, which allows early detection of Covid-19 associated nephritis and to classify the risk for respiratory decompensation by quantification of severity of nephrotic syndrome.
The rationale of the observational study can be explained by the hypothesis that Covid-19 causes Nephritis: Podocytes express high levels of ACE2, which makes the glomerulus to a target for Covid-19. Other zoonoses, such as Hanta-virus, are a well described cause of nephrotic syndrome inducing cardiopulmonary syndrome. Life-threatening complications of severe nephrotic syndrome are well known as are preventive therapies.
Covid-19 ICU patients with nephritis have
- pulmonary interstitial edema, possibly also due to capillary leak/ nephrotic syndrome;
- immune-incompetence, due to renal loss of immunoglobulins;
- circulatory insufficiency, due to hypalbuminemia (which might explain sudden deaths in the geriatric population);
- less response to some medications caused by impaired plasma protein binding of drugs due to hypalbuminemia and renal loss;
- thromboembolic events, due to antithrombin-deficiency (which might explain lethality in oligo-symptomatic young patients).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •approved Covid-19 diagnosis (by PCR or CT-scan);
- •urine status during hospital stay
- •Patient expressed willingness to participate in observational studies during hospital admission.
排除标准
- •Patient expressed unwillingness to participate in observational studies during hospital admission.
结局指标
主要结局
Time to Disease-Aggravation
时间窗: during first 10 days after admission to hospital
Time (in days) from hospital admission to transferral to ICU (ICU level high) OR time (in days) from Hospital Admission to Death
次要结局
- Blood-test(during hospital stay, up to 2 months)
- Complications(during first 10 days after admission to hospital)
- Resources(during hospital stay, up to 2 months)
研究者
Prof. Dr. O. Gross
Professor
University Hospital Goettingen