ICU Trial in Critical Ill COVID-19 Patients

Covid19 Clinical Trial

— POINT-C  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04349982
• Other study ID #: 250320
• Status: Completed
• Start date: April 8, 2020
• Est. completion date: March 31, 2022

Study information

• Verified date: April 2022
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: March 31, 2022
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Course Illness
• COVID-19
• Covid19
• Critical Illness
• Risk Factor, Cardiovascular

Intervention

Diagnostic Test:
• Biomarker (TropT, Myoglobin, CK, CK-MB, LDH, D-dimer, CRP, PCT)
Factorial

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz	Styria

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

References & Publications (4)

Li B, Yang J, Zhao F, Zhi L, Wang X, Liu L, Bi Z, Zhao Y. Prevalence and impact of cardiovascular metabolic diseases on COVID-19 in China. Clin Res Cardiol. 2020 May;109(5):531-538. doi: 10.1007/s00392-020-01626-9. Epub 2020 Mar 11. Review. — View Citation

Lippi G, Lavie CJ, Sanchis-Gomar F. Cardiac troponin I in patients with coronavirus disease 2019 (COVID-19): Evidence from a meta-analysis. Prog Cardiovasc Dis. 2020 May - Jun;63(3):390-391. doi: 10.1016/j.pcad.2020.03.001. Epub 2020 Mar 10. Review. — View Citation

Yang J, Zheng Y, Gou X, Pu K, Chen Z, Guo Q, Ji R, Wang H, Wang Y, Zhou Y. Prevalence of comorbidities and its effects in patients infected with SARS-CoV-2: a systematic review and meta-analysis. Int J Infect Dis. 2020 May;94:91-95. doi: 10.1016/j.ijid.2020.03.017. Epub 2020 Mar 12. — View Citation

Zheng YY, Ma YT, Zhang JY, Xie X. COVID-19 and the cardiovascular system. Nat Rev Cardiol. 2020 May;17(5):259-260. doi: 10.1038/s41569-020-0360-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ICU CV risk and Biomarker (e.g. Troponin)	Troponin courses in the intensive care unit are analyzed in consideration of the respective cardiovascular risk.	through study completion, up to 4 weeks
Secondary	CV risk and Outcome during ICU stay	The 30-day mortality during the ICU stay is determined and divided into appropriate cardiovascular risk groups.	through study completion, up to 4 weeks