Mechanisms for Organ Dysfunction in Covid-19

Recruiting

• Conditions: Acute Respiratory Distress Syndrome; Organ Dysfunction Syndrome, Multiple; Septic Shock; Organ Dysfunction Syndrome Sepsis; COVID-19; Acute Kidney Injury

• Registration Number: NCT04316884
• Lead Sponsor: Uppsala University

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.

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 Timeline

• Study Start: 2020-03-12
• Study First Submitted: 2020-03-13
• Study First Submitted QC: 2020-03-18
• Study First Posted: 2020-03-20
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-15
• Last Update Posted: 2024-05-16
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

Exclusion Criteria

• Pregnancy or breastfeeding
• Under-age

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acute Kidney Injury	During Intensive Care, an estimated average of 10 days.	KDIGO AKI score

Secondary Outcome Measures

Name	Time	Method
ARDS	During intensive care, an estimated average of 10 days.	Acute Respiratory Distress Syndrome yes/no
30 day mortality	30 days	Death within 30 days of ICU admission
SOFA-score	During Intensive Care, an estimated average of 10 days.	Sequential Organ Failure Score as a continuous variable
Chronic Kidney Disease	60 days and 1 year after ICU admission	Development of Chronic Kidney Disease
ICUAW	During intensive care or after intensive care	Intensive care acquired weakness
1 year mortality	1 year	Death within 1 year of ICU admission
Thromboembolic events	During intensive care	Occurence of thrombosis and/or embolous

Trial Locations

Locations (1)

Uppsala University Hospital; 🇸🇪 Uppsala, Sweden