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Mechanisms for Organ Dysfunction in Covid-19 (UMODCOVID19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04316884
Recruitment Status : Recruiting
First Posted : March 20, 2020
Last Update Posted : May 31, 2022
Sponsor:
Information provided by (Responsible Party):
Robert Frithiof, Uppsala University

Study Description
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Brief Summary:
The study aims to investigate organ dysfunction and biomarkers in patients with suspected or verified COVID-19 during intensive care at Uppsala University Hospital.

Condition or disease
COVID-19 Organ Dysfunction Syndrome Sepsis Organ Dysfunction Syndrome, Multiple Septic Shock Acute Kidney Injury Acute Respiratory Distress Syndrome

Detailed Description:
Consenting patients with suspected or verified SARS-COV-2 infection, COVID-19, will undergo daily blood, urine and sputum sampling during their stay in intensive care. Data on organ dysfunction will be collected through the electronic patient journal and electronic patient data management system. The collected samples will be analysed for a panel of potential biomarkers that will be correlated to organ dysfunction and clinical outcome.
Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Uppsala Intensive Care Study of Mechanisms for Organ Dysfunction in Covid-19
Actual Study Start Date : March 12, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
COVID-19
Patients with suspected or verified COVID-19 admitted to intensive care at Uppsala University Hospital


Outcome Measures
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Primary Outcome Measures :
  1. Acute Kidney Injury [ Time Frame: During Intensive Care, an estimated average of 10 days. ]
    KDIGO AKI score


Secondary Outcome Measures :
  1. ARDS [ Time Frame: During intensive care, an estimated average of 10 days. ]
    Acute Respiratory Distress Syndrome yes/no

  2. 30 day mortality [ Time Frame: 30 days ]
    Death within 30 days of ICU admission

  3. 1 year mortality [ Time Frame: 1 year ]
    Death within 1 year of ICU admission

  4. Chronic Kidney Disease [ Time Frame: 60 days and 1 year after ICU admission ]
    Development of Chronic Kidney Disease

  5. SOFA-score [ Time Frame: During Intensive Care, an estimated average of 10 days. ]
    Sequential Organ Failure Score as a continuous variable

  6. Thromboembolic events [ Time Frame: During intensive care ]
    Occurence of thrombosis and/or embolous

  7. ICUAW [ Time Frame: During intensive care or after intensive care ]
    Intensive care acquired weakness


Biospecimen Retention:   Samples With DNA
Blood, Urine and Sputum

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients requiring intensive care with suspected or verified COVID19
Criteria

Inclusion Criteria:

  • Admitted to intensive care
  • suspected or verified COVID-19

Exclusion Criteria:

  • Pregnancy or breastfeeding
  • Under-age
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04316884


Contacts
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Contact: Robert Frithiof, MD. PhD. 0736563473 robert.frithiof@surgsci.uu.se
Contact: Sara Bülow Anderberg, MD. 0730247414 sarabulow@gmail.com

Locations
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Sweden
Uppsala University Hospital Recruiting
Uppsala, Sweden, 75185
Contact: Robert Frithiof, MD. PhD.    073-6563473    robert.frithiof@surgsci.uu.se   
Contact: Sara Bülow Anderberg, MD.    073-0247414    sarabulow@gmail.com   
Principal Investigator: Robert Frithiof, MD. PhD.         
Sub-Investigator: Sara Bülow Anderberg, MD.         
Sub-Investigator: Michael Hultström, MD. PhD.         
Sub-Investigator: Miklos Lipcsey, MD. PhD.         
Sponsors and Collaborators
Uppsala University
Investigators
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Principal Investigator: Robert Frithiof, MD. PhD Uppsala University Hospital
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Robert Frithiof, Associate Professor, Uppsala University
ClinicalTrials.gov Identifier: NCT04316884    
Other Study ID Numbers: EPN 2017/043 Covid19
First Posted: March 20, 2020    Key Record Dates
Last Update Posted: May 31, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: IPD may be made available upon reasonable request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Acute Kidney Injury
Syndrome
Systemic Inflammatory Response Syndrome
Multiple Organ Failure
Disease
Pathologic Processes
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Respiration Disorders
Infant, Premature, Diseases