NCT04818463

Brief Summary

As part of the internal quality management (QM project), this retrospective cohort study examines the adherence to Standard Operating Procedures (SOP) of the COVID-19 patients treated since January 1st, 2020 to February 28th, 2021 in intensive care units of the Clinic for Anesthesiology m.S. operative intensive care medicine CCM / CVK.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 26, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2023

Completed
Last Updated

October 28, 2024

Status Verified

October 1, 2024

Enrollment Period

2.2 years

First QC Date

March 18, 2021

Last Update Submit

October 25, 2024

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

  • SOP "Analgesia, sedation, delirium and pain therapy"

    SOP adherence to the selected SOP "Analgesia, sedation, delirium and pain therapy". Process: daily implementation yes / no - yes\> 70%

    01.01.2020 - 28.02.2021

Secondary Outcomes (5)

  • SOP "Treatment of acute respiratory distress syndrome (ARDS)"

    01.01.2020 - 28.02.2021

  • SOP "Infectious treatment"

    01.01.2020 - 28.02.2021

  • SOP "Weaning"

    01.01.2020 - 28.02.2021

  • SOP "Nutrition"

    01.01.2020 - 28.02.2021

  • SOP "Sepsis"

    01.01.2020 - 28.02.2021

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

During the intensive care stay with SARS-CoV-2 infected intensive care adult patients

You may qualify if:

  • During the intensive care stay with SARS-CoV-2 infected intensive care patients of the Charité - Universitätsmedizin Berlin, admitted to the intensive care units of the Department of Anesthesiology and operative intensive care medicine (CCM / CVK)
  • Treatment period: 01/01/2020 to 02/28/2021
  • At least 18 years old

You may not qualify if:

  • Incomplete electronic documentation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Campus Virchow-Klinikum

Berlin, 13353, Germany

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Claudia Spies, MD, Prof.

    Charite University, Berlin, Germany

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Department of Anesthesiology and Intensive Care Medicine (CCM/CVK)

Study Record Dates

First Submitted

March 18, 2021

First Posted

March 26, 2021

Study Start

April 1, 2021

Primary Completion

June 21, 2023

Study Completion

June 21, 2023

Last Updated

October 28, 2024

Record last verified: 2024-10

Locations

DE(1)