UMODCOVID19: Mechanisms for Organ Dysfunction in Covid-19

• Sponsor: Uppsala University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04316884
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Anticipated Duration (Months): 45.6
• Patients Per Site Per Month: 6.6

Study Details

Study Description

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	Intervention/Treatment	Phase
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

• Study Type: Observational
• Anticipated 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: Mar 12, 2020
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
COVID-19 Patients with suspected or verified COVID-19 admitted to intensive care at Uppsala University Hospital

Outcome Measures

Primary Outcome Measures

1. Acute Kidney Injury [During Intensive Care, an estimated average of 10 days.]

   KDIGO AKI score

Secondary Outcome Measures

1. ARDS [During intensive care, an estimated average of 10 days.]

   Acute Respiratory Distress Syndrome yes/no

2. 30 day mortality [30 days]

   Death within 30 days of ICU admission

3. 1 year mortality [1 year]

   Death within 1 year of ICU admission

4. Chronic Kidney Disease [60 days and 1 year after ICU admission]

   Development of Chronic Kidney Disease

5. SOFA-score [During Intensive Care, an estimated average of 10 days.]

   Sequential Organ Failure Score as a continuous variable

6. Thromboembolic events [During intensive care]

   Occurence of thrombosis and/or embolous

7. ICUAW [During intensive care or after intensive care]

   Intensive care acquired weakness

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Admitted to intensive care

• suspected or verified COVID-19

Exclusion Criteria:

• Pregnancy or breastfeeding

• Under-age

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Uppsala University Hospital	Uppsala		Sweden	75185

Sponsors and Collaborators

• Uppsala University

Investigators

• Principal Investigator: Robert Frithiof, MD. PhD, Uppsala University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Robert Frithiof, Associate Professor, Uppsala University
• ClinicalTrials.gov Identifier: NCT04316884
• Other Study ID Numbers: EPN 2017/043 Covid19
• First Posted: Mar 20, 2020
• Last Update Posted: May 31, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Acute Kidney Injury; Syndrome; Systemic Inflammatory Response Syndrome; Multiple Organ Failure

Study Results

No Results Posted as of May 31, 2022