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

April 4, 2022 updated by: Martin Rief, Medical University of Graz

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this prospective observational study the course of 30-50 intensive care patients of the University Hospital of Graz is analysed.

It is not possible to give an exact number of cases, because it is not possible to estimate exactly how many COVID-19 patients will be admitted to the listed intensive care units in Graz. Recruitment will start when approved from the ethical board and end in June, 2020.

Inclusion criteria

  • Admission on an isolation unit - intensive care unit of the University Clinic of Graz
  • Detection of a SARS - CoV-2 infection by PCR (tracheal or pharyngeal secretion) or CT examination (with consecutive PCR confirmation)
  • male and female sex
  • subordinated declaration of consent if possible*
  • respiratory insufficiency with indication for non-invasive or invasive ventilation during admission to an intensive care unit

Informed consent

Since the study patients are intensive care patients, it may happen that the informed consent cannot be obtained at the time of admission to the intensive care unit (e.g.: patient is not able to give consent due to mechanical ventilation), in this case the informed consent will be obtained at a later time (e.g.: at the latest upon discharge from the intensive care unit/hospital.

(* In exceptional cases it may happen that patients cannot sign a declaration of consent at admission as well as at discharge from the intensive care unit (e.g.: during the stay continuous mechanical ventilation and death at the intensive care unit).

Study related measures

In addition to the standardized routine laboratory (daily, in the morning approx. 05.00 o'clock), a lipid profile (LDL cholesterol, triglycerides, Lpa, HDL cholesterol, total cholesterol) is taken once upon admission to the intensive care unit in order to determine the cardiovascular risk upon admission to the intensive care unit. This lipid profile is taken with the aid of a vacuette (9 ml corresponds to approx. 2 teaspoons of whole blood).

Study related patient questionnaire for the determination of cardiovascular risk

The patient questionnaire should be filled out by interviewing the patients at the time of admission to the intensive care unit. If the condition of the patients does not allow this, the information in the questionnaire should be carried out by a member of the study staff by researching the patient's medical history (e.g. doctor's letters, electronic data acquisition, etc.). The questionnaire is used to assess the cardiovascular risk (contains medication, past medical history).

Non-study-related measures (standardised routine analyses in an intensive care unit)

To determine the cardiovascular risk:

See Patient Questionnaire, Lipid Status, HbA1c

For follow-up (daily routine laboratory checks):

Blood count, coagulation, liver and kidney counts, triglycerides, biomarkers (CK, CK-MB, TropT, NTproBNP, CRP, PCT, IL-6, D-dimer, LDH, myoglobin).

Other parameters and therapies that are considered in the evaluation or that are used to create the data set:

Fluid introduction, fluid discharge, balance, prone positioning, non-invasive ventilation (PEEP, fiO2), invasive ventilation (ventilation mode, PEEP, Pinsp, fiO2, AF), respiration (respiratory rate, fiO2, SpO2, paO2, pCO2, etCO2), circulation parameters (RR syst, RR dia, MAP, HF, ECG (rhythm, Qtc)), extracorporeal organ support procedures, mortality, med. complications, entire drug therapy (e.g: norepinephrine (incl. dose), levosimendan (incl. dose), vasopressin (incl. dose), cortisone (incl. dose), dobutamine (incl. dose), supportive therapy (zinc, vitamin C, selenium), antifungal and antibiotic therapy, hydroxychloroquine, lopinavir, remdesivir, favipiravir, tocilizumab.

Anonymisation of patients

After enrolment in the study, the patient data is encoded/pseudo-anonymised, i.e. patients are identified with a consecutive ID number (neither name, initials nor laboratory requirement number are recorded). To find out the previous illnesses of intensive care patients it is necessary to create a list of patient names and the corresponding ID numbers for pseudonymisation. This list remains with the investigator.

Use of clinical data For the statistical analysis, clinical data in pseudo-anonymised/encoded form are used, e.g. diagnosis, concomitant diseases, long-term medication, intensive care therapy, medication, smoking, age, sex.

Should further questions arise during the study regarding this patient collective, the collected data would be used for further evaluations.

Centre/intensive care units The test centre is the LKH Univ.Klinikum Graz, Auenbruggerplatz 5, A-8036 Graz. Patients are admitted to the SARS - CoV-2 (COVID-19) isolation unit intensive care units of the LKH University Hospital Graz.

Study Type

Observational

Enrollment (Actual)

31

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

  • Austria
    • Styria
      • Graz, Styria, Austria
        • Medical University of Graz

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with respiratory insufficiency and current COVID-19 infection with different gender, age and previous diseases.

Description

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

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: Prospective

Cohorts and Interventions

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 Names:
  • 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 Names:
  • 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 Names:
  • Fluid management (fluid input, fluid output), prone positioning, ventilation, respiration, circulation parameters, extracorporeal organ support procedures, mortality, MACE, entire drug therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, up to 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, up to 4 weeks

Collaborators and Investigators

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

Sponsor

Medical University of Graz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 8, 2020

Primary Completion (Actual)

March 1, 2021

Study Completion (Actual)

March 31, 2022

Study Registration Dates

First Submitted

April 10, 2020

First Submitted That Met QC Criteria

April 14, 2020

First Posted (Actual)

April 16, 2020

Study Record Updates

Last Update Posted (Actual)

April 12, 2022

Last Update Submitted That Met QC Criteria

April 4, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 250320

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

If other researchers need the medical data of this study for their research projects, the data will be made available after consideration for co-autorship.

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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