Neurogenic Myocardial and Lung Injury in SAH Patients

May 4, 2023 updated by: Medical University of Silesia

The Relationship Between Urine Metanephrine Concentration and Myocardial and Lung Injury in Subarachnoid Haemorrhage Patients: a Prospective Observational Study

Up to this day, little is known whether the extent of brain damage in patients with SAH correlates with the degree neurogenic myocardial injury and neurogenic lung injury.

This is a prospective observational study designed to asses relationship between catecholamine surge and development of myocardial and lung injury in subarachnoid haemorrhage patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Multiple forms of brain damage, primarily, subarachnoid haemorrhage (SAH) are frequently accompanied by neurogenic myocardial injury with changes in the electrocardiogram, accompanied by the release of markers of myocardial injury. This form of cardiac dysfunction is thought to be mediated by cellular toxicity associated with catecholamine release. Central nervous system damage in the course of intracranial haemorrhage may, in a similar pathogenic pathway, lead to neurogenic lung injury. Up to this day, little is known whether the extent of brain damage in patients with SAH correlates with the degree of neurogenic myocardial injury. Moreover, it remains unknown what is the full clinical picture and duration of this type of myocardial injury and how often it co-occurs with neurogenic lung injury. Such analysis is a fundamental and most important step in optimising the treatment of these patients.

Methods: In this prospective observational study the authors aim to recruit 30 patients with subarachnoid haemorrhage, requiring hospitalization in the Intensive Care Unit. The patients will be monitored for elevation in cardiac damage markers (hs-TnT, CPK, CK-MB, NT-proBNP) and worsening of respiratory conditions, defined by need for more invasive ventilation parameters, and subsequent changes in arterial blood gas. The above mentioned parameters will be assessed every 12 hours. Additionally, the patients will be screened for an elevation in catecholamine metabolite (metanephrine) concentration in 12-hour urine collection.

Hypothesis to be tested: Myocardial and lung injury in SAH patients is timely-associated with an increase in metanephrine concentration in urine.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Poland
    • Województwo Śląskie
      • Katowice, Województwo Śląskie, Poland, 40-752
        • Recruiting
        • University Clinical Center prof. K. Gibiński of the Medical University of Silesia in Katowice
        • Contact:
        • Principal Investigator:
          • Natalia Rachfalska

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

Sampling Method

Non-Probability Sample

Study Population

Patients with subarachnoid haemorrhage admitted to the Intensive Care Unit.

Description

Inclusion Criteria:

  • patients with subarachnoid haemorrhage (both aneurysmal and non-aneurysmal) with acute consciousness disturbances (Glasgow Coma Scale < 8 pts) requiring intubation and mechanical ventilation, hospitalized in the ICU for over 24 hours

Exclusion Criteria:

  • severe prior pulmonary diseases
  • severe prior cardiac diseases
  • death in the first 72 hours of ICU stay
  • need for any extracorporeal life-saving techniques

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with subarachnoid haemorrhage
Patients aged 18 or older hospitalized in the Intensive Care Unit with Subarachnoid Haemorrhage.
Diagnostic test: hs-TnT (high-sensitive cardiac troponin T) plasma concentration
hs-TnT plasma concentration measured once every 12 hours
Diagnostic test: CK-MB (creatine kinase myocardial band) plasma concentration
CK-MB plasma concentration measured every 12 hours
Diagnostic test: CPK (creatine phosphokinase) plasma concentration
CPK plasma concentration measured every 12 hours
Diagnostic test: NT-proBNP (N-terminal prohormone of brain natriuretic peptide) plasma concentration
NT-proBNP plasma concentration measured every 12 hours
Diagnostic test: Metanephrine concentration in urine
Metanephrine concentration measured in 12-hour urine collection using spectrophotometry.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-hospital death (number of patients)
Time Frame: 7 days
Death of the patient during the first 7 days of hospitalization.
7 days
Number of Patients with elevation in hs-TnT levels
Time Frame: 7 days
hs-TnT treated as myocardial injury biomarker
7 days
Number of Patients with elevation in NT-proBNP levels
Time Frame: 7 days
NT-proBNP treated as myocardial injury biomarker
7 days
Number of Patients with elevation in creatine kinase levels
Time Frame: 7 days
Creatine kinase treated as myocardial injury biomarker
7 days
Number of Patients with elevation in creatine kinase MB levels
Time Frame: 7 days
Creatine kinase MB treated as myocardial injury biomarker
7 days
Number of Patients with a decrease in Horowitz index
Time Frame: 7 days
The decrease in Horowitz index treated as a sign of need for more invasive ventilation parameters with subsequent blood gas changes
7 days
Number of Patients with need of increased FiO2
Time Frame: 7 days
Need of increased FiO2 treated as a sign of need for more invasive ventilation parameters with subsequent blood gas changes
7 days
Number of Patients with need of increased PEEP values
Time Frame: 7 days
Need of increased PEEP values treated as a sign of need for more invasive ventilation parameters with subsequent blood gas changes
7 days
Number of Patients with need for the use of neuro-muscular blocking agents
Time Frame: 7 days
Need for the use of neuro-muscular blocking agents treated as a sign of need for more invasive ventilation parameters with subsequent blood gas changes
7 days

Collaborators and Investigators

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

Sponsor

Medical University of Silesia

Investigators

  • Study Chair: Łukasz Krzych, PhD, University Clinical Center prof. K. Gibiński of the Medical University of Silesia in Katowice

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)

January 22, 2022

Primary Completion (Anticipated)

June 30, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

February 2, 2022

First Submitted That Met QC Criteria

June 6, 2022

First Posted (Actual)

June 7, 2022

Study Record Updates

Last Update Posted (Estimate)

May 5, 2023

Last Update Submitted That Met QC Criteria

May 4, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCN/0022/KB/206/20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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