Clinical trial NCT05408988: Neurogenic Myocardial and Lung Injury in SAH Patients
Official title: The Relationship Between Urine Metanephrine Concentration and Myocardial and Lung Injury in Subarachnoid Haemorrhage Patients: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myocardial Injury
Lung Injury
Subarachnoid Hemorrhage
Keywords: myocardial injury
lung injury
SAH
subarachnoid haemorrhage
metanephrine
catecholamine-induced injury
Intensive Care Unit
neurocritical care
Lead sponsor: Medical University of Silesia
Sponsor class: OTHER
First posted: 2022-06-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with subarachnoid haemorrhage admitted to the Intensive Care Unit.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: In-hospital death (number of patients)
timeFrame: 7 days
measure: Number of Patients with elevation in hs-TnT levels
timeFrame: 7 days
measure: Number of Patients with elevation in NT-proBNP levels
timeFrame: 7 days
measure: Number of Patients with elevation in creatine kinase levels
timeFrame: 7 days
measure: Number of Patients with elevation in creatine kinase MB levels
timeFrame: 7 days
measure: Number of Patients with a decrease in Horowitz index
timeFrame: 7 days
measure: Number of Patients with need of increased FiO2
timeFrame: 7 days
measure: Number of Patients with need of increased PEEP values
timeFrame: 7 days
measure: Number of Patients with need for the use of neuro-muscular blocking agents
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Katowice
country: Poland
facility: University Clinical Center prof. K. Gibiński of the Medical University of Silesia in Katowice
state: Województwo Śląskie
Study officials:
affiliation: University Clinical Center prof. K. Gibiński of the Medical University of Silesia in Katowice
name: Łukasz Krzych, PhD
role: STUDY_CHAIR
References:
citation: Osgood ML. Aneurysmal Subarachnoid Hemorrhage: Review of the Pathophysiology and Management Strategies. Curr Neurol Neurosci Rep. 2021 Jul 26;21(9):50. doi: 10.1007/s11910-021-01136-9.
citation: Hofman M, Hajder N, Duda I, Krzych LJ. A Questionnaire Survey of Management of Patients with Aneurysmal Subarachnoid Haemorrhage in Poland. Int J Environ Res Public Health. 2020 Jun 11;17(11):4161. doi: 10.3390/ijerph17114161.
citation: Wybraniec MT, Mizia-Stec K, Krzych L. Neurocardiogenic injury in subarachnoid hemorrhage: A wide spectrum of catecholamin-mediated brain-heart interactions. Cardiol J. 2014;21(3):220-8. doi: 10.5603/CJ.a2014.0019. Epub 2014 Feb 14.
citation: Wybraniec M, Mizia-Stec K, Krzych L. Stress cardiomyopathy: yet another type of neurocardiogenic injury: 'stress cardiomyopathy'. Cardiovasc Pathol. 2014 May-Jun;23(3):113-20. doi: 10.1016/j.carpath.2013.12.003. Epub 2013 Dec 27.
citation: Veeravagu A, Chen YR, Ludwig C, Rincon F, Maltenfort M, Jallo J, Choudhri O, Steinberg GK, Ratliff JK. Acute lung injury in patients with subarachnoid hemorrhage: a nationwide inpatient sample study. World Neurosurg. 2014 Jul-Aug;82(1-2):e235-41. doi: 10.1016/j.wneu.2014.02.030. Epub 2014 Feb 20.
citation: Mazeraud A, Robba C, Rebora P, Iaquaniello C, Vargiolu A, Rass V, Bogossian EG, Helbok R, Taccone FS, Citerio G. Acute Distress Respiratory Syndrome After Subarachnoid Hemorrhage: Incidence and Impact on the Outcome in a Large Multicenter, Retrospective Cohort. Neurocrit Care. 2021 Jun;34(3):1000-1008. doi: 10.1007/s12028-020-01115-x. Epub 2020 Oct 20.
citation: Anetsberger A, Jungwirth B, Blobner M, Ringel F, Bernlochner I, Heim M, Bogdanski R, Wostrack M, Schneider G, Meyer B, Graessner M, Baumgart L, Gempt J. Association of Troponin T levels and functional outcome 3 months after subarachnoid hemorrhage. Sci Rep. 2021 Aug 9;11(1):16154. doi: 10.1038/s41598-021-95717-w.