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

October 25, 2024 updated by: Claudia Spies, Charite University, Berlin, Germany
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2398

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of delirium
Time Frame: 01.01.2020 - 21.02.2022
Delirium is measured by validated screening scores.
01.01.2020 - 21.02.2022

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Risk factors for severe COVID-19
Time Frame: 01.01.2020 - 21.02.2022
Risk factors are defined according to actual literature e.g. obesity, diabetes or hypertension.
01.01.2020 - 21.02.2022
Patient characteristics
Time Frame: 01.01.2020 - 21.02.2022
Patient characteristics at hospital admission e.g. score level
01.01.2020 - 21.02.2022
Blood gas analysis
Time Frame: 01.01.2020-31.07.2020
Monitoring of blood gas analysis
01.01.2020-31.07.2020
Enteral nutrition
Time Frame: 01.01.2020-31.07.2020
Monitoring of enteral nutrition
01.01.2020-31.07.2020
Parenteral nutrition
Time Frame: 01.01.2020 - 21.02.2022
Monitoring of parenteral nutrition
01.01.2020 - 21.02.2022
Serum albumin
Time Frame: 01.01.2020 - 21.02.2022
Monitoring of serum albumin level
01.01.2020 - 21.02.2022
Total protein
Time Frame: 01.01.2020 - 21.02.2022
Monitoring of total protein level
01.01.2020 - 21.02.2022
Phosphate
Time Frame: 01.01.2020 - 21.02.2022
Monitoring of phosphate levels
01.01.2020 - 21.02.2022
Triglyceride
Time Frame: 01.01.2020 - 21.02.2022
Monitoring of triglyceride levels
01.01.2020 - 21.02.2022
Caloric intake
Time Frame: 01.01.2020 - 21.02.2022
Caloric intake is measured by total daily energy supply.
01.01.2020 - 21.02.2022
Respiratory setting
Time Frame: 01.01.2020 - 21.02.2022
Respiratory factors are measured respiratory setting
01.01.2020 - 21.02.2022
Inflammatory laboratory parameter 1
Time Frame: 01.01.2020 - 21.02.2022
Monitoring of interleukine level
01.01.2020 - 21.02.2022
Inflammatory laboratory parameter 2
Time Frame: 01.01.2020 - 21.02.2022
Monitoring of cytokine level
01.01.2020 - 21.02.2022
Inflammatory laboratory parameter 3
Time Frame: 01.01.2020 - 21.02.2022
Monitoring of big immune status
01.01.2020 - 21.02.2022
Inflammatory laboratory parameter 4
Time Frame: 01.01.2020 - 21.02.2022
Monitoring of t-cell population
01.01.2020 - 21.02.2022
Toxic-drug factors
Time Frame: 01.01.2020 - 21.02.2022
Toxic-drug factors are measured by concomitant medication.
01.01.2020 - 21.02.2022
Sociodemographic factors
Time Frame: 01.01.2020 - 21.02.2022
Sociodemographic factors are measured by Audit, Fagerström, occupation, age, gender, cognitive status.
01.01.2020 - 21.02.2022
Breathing hours
Time Frame: 01.01.2020 - 21.02.2022
Breathing hours are measured by non-invasive and invasive ventilation.
01.01.2020 - 21.02.2022
Length of intensive care unit stay
Time Frame: 01.01.2020 - 21.02.2022
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
Time Frame: 01.01.2020 - 21.02.2022
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)
Time Frame: 01.01.2020 - 21.02.2022
Post Intensive Care Unit Syndrome (PICS) is measured by a validated battery (composite endpoint).
01.01.2020 - 21.02.2022
In-hospital mortality
Time Frame: 01.01.2020 - 21.02.2022
Mortality is measured in the hospital
01.01.2020 - 21.02.2022
Length of hospital stay
Time Frame: 01.01.2020 - 31.07.2022
Length of hospital stay is measured in days of stay in hospital.
01.01.2020 - 31.07.2022
Mortality
Time Frame: 01.01.2020 - 31.08.2022
Mortality is measured until 180 days
01.01.2020 - 31.08.2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Charite University, Berlin, Germany

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Claudia Spies, MD, Prof., Charité - Universitäsmedizin Berlin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 21, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 21, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 1, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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