Delirium in Covid-19: Germany-wide Covid-19 Intensive Register

The global pandemic caused by the SARS-CoV-2 virus is confronting the German health system with a novel pathogen. This means that a timely evaluation of all available results is required. In the field of intensive care in particular, there are significant gaps in knowledge, particularly with regard to delirium. In this respect, this study also serves directly to investigate the pathways of delirium outcome in COVID-19 patients.

Study Overview

• Status: Completed
• Conditions: Covid19; Post Intensive Care Unit Syndrome; Intensive Care Unit Delirium

• Study Type: Observational
• Enrollment (Actual): 2398

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Department of Anesthesiology and Operative Intensive Care Medicine Campus Virchow-Klinikum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients who have COVID-19 and have been treated in an intensive care unit of Charité Universitätsmedizin and whose therapy has already been completed on 21.02.2022.

Description

Inclusion Criteria:

All patients with SARS-CoV-2 positive Covid-19 disease

• Age≥18 years
• Proven by positive PCR tests from nasal/ throat swabs as well as samples from the deep respiratory tract.
• Period 01.01.2020 to 21.02.2022

Exclusion Criteria:

• NONE

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of delirium	Delirium is measured by validated screening scores.	01.01.2020 - 21.02.2022

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk factors for severe COVID-19	Risk factors are defined according to actual literature e.g. obesity, diabetes or hypertension.	01.01.2020 - 21.02.2022
Patient characteristics	Patient characteristics at hospital admission e.g. score level	01.01.2020 - 21.02.2022
Blood gas analysis	Monitoring of blood gas analysis	01.01.2020-31.07.2020
Enteral nutrition	Monitoring of enteral nutrition	01.01.2020-31.07.2020
Parenteral nutrition	Monitoring of parenteral nutrition	01.01.2020 - 21.02.2022
Serum albumin	Monitoring of serum albumin level	01.01.2020 - 21.02.2022
Total protein	Monitoring of total protein level	01.01.2020 - 21.02.2022
Phosphate	Monitoring of phosphate levels	01.01.2020 - 21.02.2022
Triglyceride	Monitoring of triglyceride levels	01.01.2020 - 21.02.2022
Caloric intake	Caloric intake is measured by total daily energy supply.	01.01.2020 - 21.02.2022
Respiratory setting	Respiratory factors are measured respiratory setting	01.01.2020 - 21.02.2022
Inflammatory laboratory parameter 1	Monitoring of interleukine level	01.01.2020 - 21.02.2022
Inflammatory laboratory parameter 2	Monitoring of cytokine level	01.01.2020 - 21.02.2022
Inflammatory laboratory parameter 3	Monitoring of big immune status	01.01.2020 - 21.02.2022
Inflammatory laboratory parameter 4	Monitoring of t-cell population	01.01.2020 - 21.02.2022
Toxic-drug factors	Toxic-drug factors are measured by concomitant medication.	01.01.2020 - 21.02.2022
Sociodemographic factors	Sociodemographic factors are measured by Audit, Fagerström, occupation, age, gender, cognitive status.	01.01.2020 - 21.02.2022
Breathing hours	Breathing hours are measured by non-invasive and invasive ventilation.	01.01.2020 - 21.02.2022
Length of intensive care unit stay	Length of intensive care unit stay is measured in days of stay in the intensive care unit.	01.01.2020 - 21.02.2022
Adverse events	Adverse Events defined by thromboembolic events, nosocomial infections, septic shock, acute renal failure, heart attack, post-intensive care syndrome and death are recorded until hospital discharge.	01.01.2020 - 21.02.2022
Post Intensive Care Unit Syndrome (PICS)	Post Intensive Care Unit Syndrome (PICS) is measured by a validated battery (composite endpoint).	01.01.2020 - 21.02.2022
In-hospital mortality	Mortality is measured in the hospital	01.01.2020 - 21.02.2022
Length of hospital stay	Length of hospital stay is measured in days of stay in hospital.	01.01.2020 - 31.07.2022
Mortality	Mortality is measured until 180 days	01.01.2020 - 31.08.2022

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Study Director: Claudia Spies, MD, Prof., Charité - Universitäsmedizin Berlin

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): February 21, 2022
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: January 21, 2021
• First Submitted That Met QC Criteria: February 26, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Actual): October 29, 2024
• Last Update Submitted That Met QC Criteria: October 25, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Delirium
• Other Study ID Numbers: COVID-19-Delirium

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No