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Hypernatremia in critically ill patients with Covid-19

Organizational Data

DRKS-ID:
DRKS00021611
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2020-05-12
Last update in DRKS:
2020-05-12
Registration type:
Prospective

Acronym/abbreviation of the study

No Entry

URL of the study

No Entry

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.

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.

Health condition or problem studied

ICD10:
E87 - Other disorders of fluid, electrolyte and acid-base balance
ICD10:
U07.1 - COVID-19, virus identified
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
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.
Arm 2:
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.

Endpoints

Primary outcome:
absolute numbers and dynamic of sodium levels
Secondary outcome:
classification of hypernatremia

Study Design

Purpose:
Basic research/physiological study
Retrospective/prospective:
No Entry
Study type:
Non-interventional
Longitudinal/cross-sectional:
No Entry
Study type non-interventional:
No Entry

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • Medical center Ortenauklinikum Lahr-Ettenheim Lahr

Recruitment period and number of participants

Planned study start date:
2020-05-15
Actual study start date:
No Entry
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
33
Final Sample Size:
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Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
100 Years
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

Exclusion Criteria

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

Addresses

Primary Sponsor

Ortenauklinikum, Betriebsstelle Lahr
Klostenstr.19
77933 Lahr
Germany
Telephone:
07821930
Fax:
07821930
Contact per E-Mail
URL:
http://www.ortenau-klinikum.de
Investigator Sponsored/Initiated Trial (IST/IIT):
No

Contact for Scientific Queries

Ortenauklinikum, Betriebsstelle Lahr
Dr. Milena Zimmer
Klostenstr. 19
77933 Lahr
Germany
Telephone:
07821931113
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Ortenauklinikum, Betriebsstelle Lahr
Dr. Milena Zimmer
Klostenstr. 19
77933 Lahr
Germany
Telephone:
07821931113
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Ortenauklinikum, Betriebsstelle Lahr
Dr. Milena Zimmer
Klostenstr. 19
77933 Lahr
Germany
Telephone:
07821931113
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)

Ortenauklinikum, Betriebsstelle Lahr
Klostenstr.19
77933 Lahr
Germany
Telephone:
07821930
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
Engelberger Str. 21
79106 Freiburg
Germany
Telephone:
+49-761-27072600
Fax:
+49-761-27072630
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2020-04-28
Ethics committee number:
273/20
Vote of the Ethics Committee:
Approved
Date of the vote:
2020-04-28

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
Studienprotokoll
Study abstract:
No Entry
Other study documents:
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Background literature:
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Related DRKS studies:
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Publication of study results

Planned publication:
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Publikationen/Studienergebnisse:
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Date of first publication of study results:
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DRKS entry published for the first time with results:
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Basic reporting

Basic Reporting / Results tables:
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Brief summary of results:
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