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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04775017
• Other study ID #: COVID-19-Delirium
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: December 2022

Study information

• Verified date: May 2022
• Source: Charite University, Berlin, Germany
• Contact: Claudia Spies, MD, Prof.
• Phone: +49 30 450 551102
• Email: claudia.spies[@]charite.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Delirium
• Intensive Care Unit Delirium
• Post Intensive Care Unit Syndrome

Locations

Country	Name	City	State
Germany	Department of Anesthesiology and Operative Intensive Care Medicine Campus Virchow-Klinikum	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of delirium	Delirium is measured by validated screening scores.	01.01.2020 - 21.02.2022
Secondary	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
Secondary	Patient characteristics	Patient characteristics at hospital admission e.g. score level	01.01.2020 - 21.02.2022
Secondary	Blood gas analysis	Monitoring of blood gas analysis	01.01.2020-31.07.2020
Secondary	Enteral nutrition	Monitoring of enteral nutrition	01.01.2020-31.07.2020
Secondary	Parenteral nutrition	Monitoring of parenteral nutrition	01.01.2020 - 21.02.2022
Secondary	Serum albumin	Monitoring of serum albumin level	01.01.2020 - 21.02.2022
Secondary	Total protein	Monitoring of total protein level	01.01.2020 - 21.02.2022
Secondary	Phosphate	Monitoring of phosphate levels	01.01.2020 - 21.02.2022
Secondary	Triglyceride	Monitoring of triglyceride levels	01.01.2020 - 21.02.2022
Secondary	Caloric intake	Caloric intake is measured by total daily energy supply.	01.01.2020 - 21.02.2022
Secondary	Respiratory setting	Respiratory factors are measured respiratory setting	01.01.2020 - 21.02.2022
Secondary	Inflammatory laboratory parameter 1	Monitoring of interleukine level	01.01.2020 - 21.02.2022
Secondary	Inflammatory laboratory parameter 2	Monitoring of cytokine level	01.01.2020 - 21.02.2022
Secondary	Inflammatory laboratory parameter 3	Monitoring of big immune status	01.01.2020 - 21.02.2022
Secondary	Inflammatory laboratory parameter 4	Monitoring of t-cell population	01.01.2020 - 21.02.2022
Secondary	Toxic-drug factors	Toxic-drug factors are measured by concomitant medication.	01.01.2020 - 21.02.2022
Secondary	Sociodemographic factors	Sociodemographic factors are measured by Audit, Fagerström, occupation, age, gender, cognitive status.	01.01.2020 - 21.02.2022
Secondary	Breathing hours	Breathing hours are measured by non-invasive and invasive ventilation.	01.01.2020 - 21.02.2022
Secondary	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
Secondary	Length of hospital stay	Length of hospital stay is measured in days of stay in hospital.	01.01.2020 - 31.07.2020
Secondary	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
Secondary	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
Secondary	In-hospital mortality	Mortality is measured in the hospital	01.01.2020 - 21.02.2022
Secondary	Mortality	Mortality is measured until 180 days	01.01.2020 - 21.02.2022