Cardiac Function in Severe Aneurysmal Subarachnoid Haemorrhage Patients (SPLASH)

May 9, 2014 updated by: Nantes University Hospital

Speckle Tracking Assessment of Cardiac Function in Severe Aneurysmal Subarachnoid Haemorrhage and Impact on Neurologic Outcome (SPLASH)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

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

Study Locations

  • France
      • Nantes, France, 44000
        • University Hospital
      • Rennes, France, 35000
        • University Hospital

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

15 years to 85 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Severe Aneurysmal subarachnoid haemorrhage

Description

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

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
Aneurysmal subarachnoid haemorrhage
Speckle-tracking images in Echocardiography
Procedure: Echocardiography
Speckle-Tracking of echocardiographic loops by a cardiologist blinded to the patient's management and outcome

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurologic outcome
Time Frame: 3 months
modified Rankin Scale (mRS). Poor neurological outcome was considered as death or severe disability (mRS 5-6).
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation between cardiac strain on day 1 and Left Ventricular Ejection fraction
Time Frame: Day 1
Day 1
Correlation between cardiac enzymes (NT-proBNP, troponin T US) and cardiac strain
Time Frame: Day 1
Day 1
Correlation between EKG findings and cardiac strain
Time Frame: Day 1
Day 1
Time to amines discontinuation
Time Frame: During Intensive Care Unit stay, expected average 17 days
During Intensive Care Unit stay, expected average 17 days
Duration of mechanical ventilation
Time Frame: Duration of mechanical ventilation, expected average 15 days
Duration of mechanical ventilation, expected average 15 days
Length of ICU stay
Time Frame: Duration of ICU stay, expected average 17 days
Duration of ICU stay, expected average 17 days
Correlation between Cardiac function and Mechanical Ventilation
Time Frame: Day1, day3, day7 and extubation time expected average 15 days
Day1, day3, day7 and extubation time expected average 15 days
Correlation between Cardiac function and ICU length of stay
Time Frame: Day1, day3, day 7 and end of stay in ICU expected average 17 days
Day1, day3, day 7 and end of stay in ICU expected average 17 days

Collaborators and Investigators

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

Sponsor

Nantes University Hospital

Investigators

  • Principal Investigator: Raphaël Cinotti, MD, Nantes University Hospital
  • Study Chair: Bertrand ROZEC, PhD, MD, Nantes University Hospital

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

January 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

February 15, 2013

First Submitted That Met QC Criteria

February 27, 2013

First Posted (Estimate)

March 1, 2013

Study Record Updates

Last Update Posted (Estimate)

May 12, 2014

Last Update Submitted That Met QC Criteria

May 9, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC12_0410

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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