Clinical trial NCT01801800: Cardiac Function in Severe Aneurysmal Subarachnoid Haemorrhage Patients
Official title: Speckle Tracking Assessment of Cardiac Function in Severe Aneurysmal Subarachnoid Haemorrhage and Impact on Neurologic Outcome (SPLASH)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aneurysmal Subarachnoid Haemorrhage
World Neurosurgeon Federation Score ≥ III
Keywords: Aneurysmal subarachnoid haemorrhage
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2013-03-01
Enrollment: 80
Sex: ALL
Minimum age (years): 15
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Severe Aneurysmal subarachnoid haemorrhage

Brief summary: Cardiac dysfunction can occur in aneurysmal subarachnoid haemorrhage and might impact patient's neurologic outcome Condition Aneurysmal subarachnoid haemorrhage World Neurosurgeon Federation Score ≥ III

Detailed description: Trans-thoracic echocardiography on day 1, day 3 and day 7 Speckle-Tracking of echocardiographic loops by a cardiologist blinded to the patient's management and outcome

Eligibility criteria: Inclusion Criteria:

* Aneurysmal subarachnoid haemorrhage
* World Neurosurgeon Federation Score ≥ III
* Written information to next-of-kin and patients when possible

Exclusion Criteria:

* History of myocardial infarction, chronic heart failure with NYHA ≥ 2, major heart surgery
* Lack of acoustic window to perform trans-thoracic echocardiography

Primary outcomes:
measure: Neurologic outcome
timeFrame: 3 months
Secondary outcomes:
measure: Correlation between cardiac strain on day 1 and Left Ventricular Ejection fraction
timeFrame: Day 1
measure: Correlation between cardiac enzymes (NT-proBNP, troponin T US) and cardiac strain
timeFrame: Day 1
measure: Correlation between EKG findings and cardiac strain
timeFrame: Day 1
measure: Time to amines discontinuation
timeFrame: During Intensive Care Unit stay, expected average 17 days
measure: Duration of mechanical ventilation
timeFrame: Duration of mechanical ventilation, expected average 15 days
measure: Length of ICU stay
timeFrame: Duration of ICU stay, expected average 17 days
measure: Correlation between Cardiac function and Mechanical Ventilation
timeFrame: Day1, day3, day7 and extubation time expected average 15 days
measure: Correlation between Cardiac function and ICU length of stay
timeFrame: Day1, day3, day 7 and end of stay in ICU expected average 17 days
Other outcomes:
Locations:
city: Nantes
country: France
facility: University Hospital
city: Rennes
country: France
facility: University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Raphael Cinotti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nantes University Hospital
name: Bertrand ROZEC, PhD, MD
role: STUDY_CHAIR
References:
citation: Hofmeijer J, Kappelle LJ, Algra A, Amelink GJ, van Gijn J, van der Worp HB; HAMLET investigators. Surgical decompression for space-occupying cerebral infarction (the Hemicraniectomy After Middle Cerebral Artery infarction with Life-threatening Edema Trial [HAMLET]): a multicentre, open, randomised trial. Lancet Neurol. 2009 Apr;8(4):326-33. doi: 10.1016/S1474-4422(09)70047-X. Epub 2009 Mar 5.