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ICU Trial in Critical Ill COVID-19 Patients (POINT-C)

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ClinicalTrials.gov Identifier: NCT04349982
Recruitment Status : Recruiting
First Posted : April 16, 2020
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
Martin Rief, Medical University of Graz

Brief Summary:

The aim of our study is to observe the intensive care course in 30-50 COVID-19 patients with regard to cardiovascular risk factors and biomarkers.

The primary objective of this study is to investigate the cardiovascular risk and its impact on cardiovascular complications in COVID-19 patients in intensive care units.

This study is designed to investigate correlations and to investigate factors influencing the course of the new viral disease COVID-19 in intensive care. Previous scientific findings are still rare due to the relevance of the disease, therefore this study is also explorative and not exclusively based on a hypothesis.

The cardiovascular risk will be assessed upon admission to the intensive care unit and subsequently the course of biomarkers (see below) will be analysed in a cohort study (no, low and high cardiovascular risk).


Condition or disease Intervention/treatment
Risk Factor, Cardiovascular Covid19 Critical Illness Course Illness Diagnostic Test: Biomarker (TropT, Myoglobin, CK, CK-MB, LDH, D-dimer, CRP, PCT)

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 30 Days
Official Title: Prospective Observational ICU Trial in Critical Ill COVID-19 Patients (POINT-C) Cardiovascular Risk and the Effects on Myocardial Events in Critical Ill COVID-19 Patients
Actual Study Start Date : April 8, 2020
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : July 31, 2022

Group/Cohort Intervention/treatment
No cardiovascular risk
If no patients with no cardiovascular risk can be included in the study, we will divide the cohorts into different categories (e.g. low, medium and high cardiovascular risk).
Diagnostic Test: Biomarker (TropT, Myoglobin, CK, CK-MB, LDH, D-dimer, CRP, PCT)
Factorial
Other Name: Fluid management (fluid input, fluid output), prone positioning, ventilation, respiration, circulation parameters, extracorporeal organ support procedures, mortality, MACE, entire drug therapy

low cardiovascular risk Diagnostic Test: Biomarker (TropT, Myoglobin, CK, CK-MB, LDH, D-dimer, CRP, PCT)
Factorial
Other Name: Fluid management (fluid input, fluid output), prone positioning, ventilation, respiration, circulation parameters, extracorporeal organ support procedures, mortality, MACE, entire drug therapy

high cardiovascular risk Diagnostic Test: Biomarker (TropT, Myoglobin, CK, CK-MB, LDH, D-dimer, CRP, PCT)
Factorial
Other Name: Fluid management (fluid input, fluid output), prone positioning, ventilation, respiration, circulation parameters, extracorporeal organ support procedures, mortality, MACE, entire drug therapy




Primary Outcome Measures :
  1. ICU CV risk and Biomarker (e.g. Troponin) [ Time Frame: through study completion, up to 4 weeks ]
    Troponin courses in the intensive care unit are analyzed in consideration of the respective cardiovascular risk.


Secondary Outcome Measures :
  1. CV risk and Outcome during ICU stay [ Time Frame: through study completion, up to 4 weeks ]
    The 30-day mortality during the ICU stay is determined and divided into appropriate cardiovascular risk groups.


Biospecimen Retention:   Samples With DNA
Lipid profile once at intensive care unit admission (9 ml whole blood).


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with respiratory insufficiency and current COVID-19 infection with different gender, age and previous diseases.
Criteria

Inclusion Criteria:

  • Admission on an isolation unit - intensive care unit of the LKH Univ. Klinikum Graz
  • Detection of a SARS - CoV-2 infection by PCR (tracheal or pharyngeal secretion) or CT examination (with subsequent PCR detection)
  • male and female sex
  • subordinated declaration of consent if possible if applicable
  • respiratory insufficiency with indication for non-invasive or invasive ventilation

Exclusion Criteria:

  • if the inclusion criteria are not met

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04349982


Contacts
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Contact: Martin Rief, Dr. (+43)0316-385 ext 84661 martin.rief@medunigraz.at
Contact: Christoph Klivinyi, Dr. (+43)0316-385 ext 13027 christoph.klivinyi@medunigraz.at

Locations
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Austria
Medical University of Graz Recruiting
Graz, Styria, Austria
Contact: Martin Rief, Dr.         
Sponsors and Collaborators
Medical University of Graz
Publications:
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Responsible Party: Martin Rief, Dr., Medical University of Graz
ClinicalTrials.gov Identifier: NCT04349982    
Other Study ID Numbers: 250320
First Posted: April 16, 2020    Key Record Dates
Last Update Posted: October 20, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: If other researchers need the medical data of this study for their research projects, the data will be made available after consideration.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Martin Rief, Medical University of Graz:
Critical Illness
Covid19
Risk Factor, Cardiovascular
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes
Fibrin fragment D
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants