Cardiopulmonary Complication in Aneurysmal Subarachnoid Haemorrhage Patients

NCT ID: NCT01670838

Last Updated: 2018-03-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 198 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2017-08-31

Brief Summary

This is a prospective cohort study investigating cardiac function and cardiac biomarkers in patients with acute Aneurysmal Subarachnoid Haemorrhage (aSAH). The aims of the study are to document the incidence of myocardial dysfunction,to find the predictive factors of myocardial dysfunction, describe heart rate variability and to assess the impact of all cardiac problems on morbidity and mortality.

Detailed Description

Laboratory markers daily: Routine laboratory test (blood gases, haemoglobin, thrombocytes, leukocytes, INR, bilirubin, creatinine, c-reactive protein, CK, CK-MB, Tnt, BNP, sodium, potassium, magnesium) are taken at 8 a.m. Study laboratory tests (sensitive ischemia markers, remodelling marker MMP-9 and CgA as surrogate marker for increased sympathetic activity) are taken four times during study period at the same time as cardiac ECHOes and Holtering. Gene sample is taken once on day one.

Primary outcome measurement is to document the incidence of myocardial dysfunction and the predictive factors during the hospital stay and at three months.

Secondary outcome is to assess the impact of cardiac problems on morbidity and mortality during first three months.

Conditions

Aneurysmal Subarachnoid Heamorrhage; Nontraumatic Subarachnoid Haemorrhage

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

subarachnoid haemorrhage

nontraumatic subarachnoid haemorrhage

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients with nontraumatic subarachnoid haemorrhage
• Age > 18 years
• Aneurysmal bleeding

Exclusion Criteria

• No consent
• Age < 18 years
• Anticipated brain death < 24 hours
• Otherwise moribund patient

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Turku University Hospital

OTHER_GOV

Sponsor Role: collaborator

Kuopio University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Maarit Lang

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stepani Bendel, PhD, MD

Role: STUDY_DIRECTOR

Senior consultant, intensivist

Maarit Lång, MD

Role: PRINCIPAL_INVESTIGATOR

Senior consultant, intensivist

Locations

Kuopio University Hospital

Kuopio, , Finland

Turku University Hospital

Turku, , Finland

Inselspital Bern

Bern, , Switzerland

Countries

Finland; Switzerland

Other Identifiers

Kuopio UH

Identifier Type: -

Identifier Source: org_study_id