An observational study in Covid-19, sponsored by University Hospital Goettingen. Completed at 1 site in Germany. Per ClinicalTrials.gov, last updated 2021-04-28.
Sponsored by University Hospital Goettingen · Observational
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.
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
In conclusion, ACE2 in the respiratory tract is the gateway for Covid-19 for infection, however, the study postulates that Covid-19 associated nephritis and severe cappillary leak/nephrotic syndrome is a major driver of adverse outcome. If confirmed by others, these findings and algorithm would allow early prediction of later need for ICU-capacity, better allocation of patients for clinical trials, and preventive strategies focused on the nephrotic syndrome including treatment, which can save lives. Same might apply for risk-evaluation of outpatients.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 223 is below the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →University Hospital Goettingen is the lead sponsor of 7 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
This observational study investigates the outcome of patients with approved Covid-19 diagnosis.
Exclusion Criteria:
This group has a normal urine status on admission to hospital. Abnormal urine status is defined anuric OR as 2\* or more of the following findings: 1. urine osmolarity below normal values 2. leukozyturia 3. hematuria 4. albuminuria/ proteinuria \* if urine is positive for nitrite or bacteria, abnormal urine status is defined as 3 or more of the findings.
This group has an abnormal urine status on admission to hospital WITHOUT serum-albumin below 2.0 g/dl AND WITHOUT antithrombin III level below 70%.
This group has an abnormal urine status on admission to hospital PLUS serum-albumin below 2.0 g/dl OR antithrombin III level below 70%.
Time to Disease-Aggravation
Time (in days) from hospital admission to transferral to ICU (ICU level high) OR time (in days) from Hospital Admission to Death
Time frame: during first 10 days after admission to hospital
Complications
Number of Complications are defined as 1. Need of transferral to "ICU low" (ICU level 1)\* 2. Need of transferral to "ICU high" (ICU level 3)\* 3. Need of mechanical ventilation\* OR 4. Need for renal replacement therapy\* OR 5. Need of extracorporeal membrane oxygenation\* OR 6. Death \* in the first 10 days after admission to hospital
Time frame: during first 10 days after admission to hospital
Resources
* Time on "ICU low" (in days), * Time on "ICU high" (in days), * Time on invasive mechanical ventilation (in days) * Time on extracorporeal membrane oxygenation (in days) * Time on renal replacement therapy (in days)
Time frame: during hospital stay, up to 2 months
Blood-test
* lowest serum-albumin * lowest antithrombin III
Time frame: during hospital stay, up to 2 months
Plan to share: Undecided — Quesionnaires will be faxed to principal investigator and be analyzed by the department of medical statistics.
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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University Hospital Goettingen