Trial document




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  DRKS00021611

Trial Description

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Title

Hypernatremia in critically ill patients with Covid-19

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

The infection caused by SARS-CoV-2 virus, in some cases, can lead to severe courses of disease, which include the failure of multiple organs such as the lungs or the kidneys. When treating severely ill patients suffering from a covid-19 infection on our intensive care unit, we detected elevated sodium levels in the blood, which appeared to correlate with the severity of the illness. Sodium is one of many electrolytes in the blood, which is crucial for the balance of fluids as well as the function of different cell types in the body. Different diseases, such as kidney disease or impaired central regulation of fluid balance as well as general treatment on the intensive care unit for different critical illnesses can lead to elevated sodium levels. The overall incidence of elevated sodium levels on the ICU ranges between 5 and 10 %. In patients with covid-19 being treated on the ICU, we see a much higher incidence. This study will compare sodium levels and other important diagnostic markers in patients with covid-19 that have been treated in the ICU, as well as patients with covid-19 treated on a general ward, and patients with acute lung failure due to other causes. The study has the goal to classify this impairment and will try to elucidate possible factors of a covid-19 infection which could lead to the elevation of sodium. The measuring of sodium levels is easy, cheap and could therefore serve as an additional parameter suitable to monitor the course of disease when treating patients with covid-19.

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Brief Summary in Scientific Language

Covid-19, the disease caused by SARS-CoV-2, is a systemic disease, which can lead to acute respiratory distress syndrome, acute kidney failure and an impairment of the gastrointestinal system. When treating critically ill patients with covid-19 infections on our ICU we detected severe hypernatremias in multiple patients. The extent of the elevation seems to correlate with the severity of the disease. This study retrospectively captures the courses of disease of 12 critically ill patients with covid-19 treated on the ICU and compares their course of disease to covid-19 patients treated on a general ward as well as a group of patients that suffered from ARDS due to other causes. The study focuses on the course of sodium levels in serum, the amounts of fluids administered, as well as the potential correlation between sodium levels and severity of disease. The collection of data will include measurements that have been taken during the course of treatment, such as lab parameters, administered medication and fluids, fluid balances as well as urine analysis. The aim of the study is to be able to classify the observed hypernatremia in the setting of a covid-19 infection and to obtain indications to the potential pathogenesis. Should a correlation of sodium levels and course of disease prove to be accurate, sodium levels could be used as one easy and cheap to obtain parameter to help interpret the course of disease in individual patients.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

[---]*

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Organizational Data

  •   DRKS00021611
  •   2020/05/12
  •   [---]*
  •   no
  •   Approved
  •   273/20, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   E87 -  Other disorders of fluid, electrolyte and acid-base balance
  •   U07.1 -  Emergency use of U07.1
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Interventions/Observational Groups

  •   patients with covid-19 treated on the icu. no new exams are being conducted. This study only looks retrospectively at the data collected while treating the patients. These include lab results of sodium, chloride, potassium, creatinin concentrations. Urine diagnostics: sodium, potassium, creatinin, urea, glucose.
  •   patients with covid-19 treated on the normal ward. no new exams are being conducted. This study only looks retrospectively at the data collected while treating the patients. These include lab results of sodium, chloride, potassium, creatinin concentrations. Urine diagnostics: sodium, potassium, creatinin, urea, glucose.
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Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Basic research/physiological study
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

absolute numbers and dynamic of sodium levels

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Secondary Outcome

classification of hypernatremia

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2020/05/15
  •   33
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   100   Years
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Additional Inclusion Criteria

group 1: patients with positive PCR for SARS-CoV-19 and treatment on ICU, respiratory symptoms with acute onset; bilateral diffuse infiltrates in imaging; interstitial edema, not explained by cardiac causes; paO2/FiO2 < 300 mmHg
group 2: patients with positive PCR for SARS-CoV-19 and treatment on general ward, no ventilation

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Exclusion Criteria

group 1&2: PCR for SARS-Cov-2 repeatedly negative
all groups: preexisting end stage renal failure with dialysis

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Ortenauklinikum, Betriebsstelle Lahr
    • Mr. 
    • Klostenstr.19
    • 77933  Lahr
    • Germany
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    • Ortenauklinikum, Betriebsstelle Lahr
    • Ms.  Dr.  Milena  Zimmer 
    • Klostenstr. 19
    • 77933  Lahr
    • Germany
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    • Ortenauklinikum, Betriebsstelle Lahr
    • Ms.  Dr.  Milena  Zimmer 
    • Klostenstr. 19
    • 77933  Lahr
    • Germany
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Sources of Monetary or Material Support

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    • Ortenauklinikum, Betriebsstelle Lahr
    • Klostenstr.19
    • 77933  Lahr
    • Germany
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    •   07821930
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

  •   Ethikvotum
  •   Studienprotokoll
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* This entry means the parameter is not applicable or has not been set.