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NCT Number: NCT07051967

Post-intensive Care Syndromes in Pregnant Patients With Respiratory Failure and COVID-19 Compared to Non-pregnant Patients With Respiratory Failure and COVID-19

The aim of this study is to characterize patients in the Post-Intensive-Care-Syndrome (PICS) outpatient clinic based on routine data and to evaluate their treatment outcome over the course of their treatment. For this purpose, data sets from approx. 40 patients who were treated in the intensive care unit subsequently evaluated in the PICS outpatient clinic between March 27, 2020, and May 6, 2024, will be analyzed.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin

Berlin, 13353, Germany

Location status: Recruiting

Location contact

Claudia Spies, MD, Prof.

PRINCIPAL_INVESTIGATOR

Claudia Spies, MD. Prof.

CONTACT

[email protected]

+49 30 450 55 11 02

Karin Steinecke, MD

SUB_INVESTIGATOR

Nicolas Paul, MD

SUB_INVESTIGATOR

Sonya Arustamyan, MD

SUB_INVESTIGATOR

About this study

This is a retrospective comparison of approximately 13 pregnant patients and approximately 27 non-pregnant patients who developed respiratory failure (also known as acute respiratory distress syndrome, or ARDS) due to COVID-19 infection. The analysis is based on routine treatment data from the Post-Intensive Care Syndrome (PICS) outpatient clinic of the Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), as well as intensive care treatment data, primarily from the Department of Anesthesiology and Intensive Care Medicine (CCM/CVK). In some cases, additional data were obtained from the Medical Clinic for Nephrology and Internal Intensive Care Medicine (CCM/CVK/CBF), the Medical Clinic specializing in Hepatology and Gastroenterology (CCM/CVK), and the Department of Infectiology, Pulmonology, and Intensive Care Medicine (CCM).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 18 years and older
  • Admission to a Charité intensive care unit and follow-up examination by the Post-Intensive-Care-Syndrome (PICS) outpatient clinic of the Department of Anesthesiology and Intensive Care Medicine between March 27, 2020 and May 6, 2024.
  • COVID-19 infection in temporal assocoation with the intensive care unit admission.
  • Intensive care unit admission with lung failure or development of lung failure in the course of intensive care unit treatment.
  • Admission to the intensive care unit with lung failure or development of lung failure during intensive care unit stay.

Exclusion criteria

  • Gender: Male
  • Diagnosis: Non-COVID or no respiratory failure

Treatment and study plan

Primary outcomes

  1. Impairment in at least one PICS domain (mobility, cognition, and/or mental health)

    Time frame: 27.03.2020-06.05.2024

    Impairment in at least one PICS domain (mobility, cognition, and/or mental health) after discharge from the ICU, assessed at the time of presentation to the PICS outpatient clinic. The planned PICS outpatient presentation takes place 3 and 6 months (ranging from 1 month to 3 years) after the initial ICU stay.

Secondary outcomes

  1. Catecholamine therapy

    Time frame: 27.03.2020-06.05.2024

    Catecholamine therapy during intensive care unit (ICU) treatment is measured in doses and duration.

  2. Extracorporeal Membrane Oxygenation treatment

    Time frame: 27.03.2020-06.05.2024

    Extracorporeal Membrane Oxygenation treatment in the ICU Yes or No

  3. Need for ventilation during ICU treatment

    Time frame: 27.03.2020-06.05.2024

    Need for ventilation during ICU treatment and, if so, ventilation route (non-invasive and invasive, endotracheal tube and tracheostomy tube) and duration of ventilation

  4. Duration of ventilation during ICU treatment

    Time frame: 27.03.2020-06.05.2024

    Duration of ventilation during ICU treatment is measured in hours

  5. Oxygenation index

    Time frame: 27.03.2020-06.05.2024

    Oxygenation index/Horowitz index is defined as the ratio of the arterial partial pressure of oxygen (PaO₂, in mmHg) to the fraction of inspired oxygen (FiO₂, expressed as a decimal).

  6. Severity of illness

    Time frame: 27.03.2020-06.05.2024

    Severity of illness during ICU treatment is assessed with validated intensive care unit scores.

  7. Incidence of delirium

    Time frame: 27.03.2020-06.05.2024

    Incidence of delirium in the ICU is measured with validated delirium scores.

  8. Duration of delirium

    Time frame: 27.03.2020-06.05.2024

    Duration of delirium in the ICU is measured in days

  9. Sedation Medications

    Time frame: 27.03.2020-06.05.2024

    Kind of medications required for sedation.

  10. Sedation dosage

    Time frame: 27.03.2020-06.05.2024

    The amount of drug required for sedation.

  11. Duration of sedation

    Time frame: 27.03.2020-06.05.2024

    Duration of sedation is measured in days.

  12. Depth of sedation

    Time frame: 27.03.2020-06.05.2024

    Depth of sedation during ICU treatment

  13. Continuous muscle relaxation

    Time frame: 27.03.2020-06.05.2024

    Continuous muscle relaxation during ICU treatment

  14. Vaccination status

    Time frame: 27.03.2020-06.05.2024

    Vaccination status at the start of ICU treatment

  15. COVID-19-specific immunotherapy

    Time frame: 27.03.2020-06.05.2024

    COVID-19-specific immunotherapy (e.g., tocilizumab, dexamethasone, baricitinib) during ICU treatment

  16. Type of Anti-infective therapy

    Time frame: 27.03.2020-06.05.2024

    Type of anti-infective therapy during ICU treatment

  17. Duration of Anti-infective therapy

    Time frame: 27.03.2020-06.05.2024

    Duration of anti-infective therapy during ICU treatment is measured in days.

  18. Week of pregnancy

    Time frame: 27.03.2020-06.05.2024

    Week of pregnancy during ICU treatment in the pregnant women group

  19. Need for a cesarean section

    Time frame: 27.03.2020-06.05.2024

    Need for a cesarean section in the pregnant women group, yes or no.

  20. Organ complications

    Time frame: 27.03.2020-06.05.2024

    Organ complications, including bleeding and pregnancy complications during hospital treatment. Data from patient records.

  21. Nutrition

    Time frame: 27.03.2020-06.05.2024

    Nutrition (enteral vs. parenteral) during ICU treatment

  22. Dialysis 1

    Time frame: 27.03.2020-06.05.2024

    Dialysis during ICU treatment (binary)

  23. Dialysis 2

    Time frame: 27.03.2020-06.05.2024

    Dialysis during ICU treatment (duration)

  24. Intensive care unit mortality

    Time frame: 27.03.2020-06.05.2024

    Data from patient records

  25. Hospital mortality

    Time frame: 27.03.2020-06.05.2024

    Data from patient records

  26. 90-day mortality

    Time frame: 27.03.2020-06.05.2024

    Data from patient records

  27. 180-day mortality

    Time frame: 27.03.2020-06.05.2024

    Data from patient records

  28. Intensive care unit length of stay

    Time frame: 27.03.2020-06.05.2024

    Participants are followed up for the duration of intensive care unit stay, an expected average of 2 days

  29. Duration of Hospital stay

    Time frame: 27.03.2020-06.05.2024

    Participants are followed up for the duration of hospital stay, an expected average of 7 days

  30. Grip strength Test

    Time frame: 27.03.2020-06.05.2024

    Grip strength at the time of presentation to the PICS outpatient clinic is measured with a dynamometer.

  31. Mobility

    Time frame: 27.03.2020-06.05.2024

    Mobility at the time of presentation to the PICS outpatient clinic is measured with the Timed Up-and-Go (TUG).

  32. Cognition 1

    Time frame: 27.03.2020-06.05.2024

    Cognition 1 at the time of presentation to the PICS outpatient clinic is measured with the MiniCog. The MiniCog consists of two items, the word recall test and the clock-drawing test. Performance in these test is rated on a scale ranging from 0 - 5, with <3 points indicating a suspicion of dementia.

  33. Cognition 2

    Time frame: 27.03.2020-06.05.2024

    Cognition 2 at the time of presentation to the PICS outpatient clinic is measured with the Animal Naming Test

  34. Mental health

    Time frame: 27.03.2020-06.05.2024

    Mental health at the time of presentation to the PICS outpatient clinic is measured with Patient Health Questionnaire-4 (It comprises the first two questions of the depression module of the PHQ-D [PHQ-2] and the first two questions of the module for assessing generalized anxiety [GAD-2]) and patient questionnaire with subjective patient assessment.

  35. PBQ Parent-Child Relationship Questionnaire

    Time frame: 27.03.2020-06.05.2024

    PBQ at the time of presentation to the PICS outpatient clinic. This questionnaire is a 25-question self-completion questionnaire, which was developed in order to recognize disorders in the mother-child relationship at an early stage.

    The questionnaire is made up of 4 scales. Scale 1 Delayed attachment cut-off 12, Scale 2 Rejection and anger cut-off 17, Scale 3 Anxiety cut-off 10 and Scale 4 Risk of child abuse cut-off 3.

  36. Edinburgh Postpartum Depression Questionnaire (EPDS)

    Time frame: 27.03.2020-06.05.2024

    The Edinburgh Postnatal Depression Scale (EDPS) was developed to identify women who may have postpartum depression. Each answer is given a score of 0 to 3 .The maximum score is 30. A score of more than 10 suggests minor or major depression may be present.

  37. Health-related quality of life

    Time frame: 27.03.2020-06.05.2024

    Health-related quality of life at the time of presentation to the PICS outpatient clinic is measured with EQ-5D-5L questionnaire. Higher Score indicate better Healt-related quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

Claudia Spies, MD Prof.

CONTACT

[email protected]

+49 30 450 551102

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 4, 2025
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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