Neurogenic Myocardial and Lung Injury in SAH Patients

Subarachnoid Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05408988
• Other study ID #: PCN/0022/KB/206/20
• Status: Recruiting
• Start date: January 22, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2023
• Source: Medical University of Silesia
• Contact: Natalia Rachfalska
• Phone: +48 32 789 42 01
• Email: n.rachfalska[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Lung Injury
• Myocardial Injury
• Subarachnoid Hemorrhage
• Wounds and Injuries

Intervention

Diagnostic Test:
• hs-TnT (high-sensitive cardiac troponin T) plasma concentration
hs-TnT plasma concentration measured once every 12 hours
• CK-MB (creatine kinase myocardial band) plasma concentration
CK-MB plasma concentration measured every 12 hours
• CPK (creatine phosphokinase) plasma concentration
CPK plasma concentration measured every 12 hours
• NT-proBNP (N-terminal prohormone of brain natriuretic peptide) plasma concentration
NT-proBNP plasma concentration measured every 12 hours
• Metanephrine concentration in urine
Metanephrine concentration measured in 12-hour urine collection using spectrophotometry.

Locations

Country	Name	City	State
Poland	University Clinical Center prof. K. Gibinski of the Medical University of Silesia in Katowice	Katowice	Województwo Slaskie

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Silesia

Country where clinical trial is conducted

Poland, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

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