Cardiopulmonary Complication in Aneurysmal Subarachnoid Haemorrhage Patients

Completed

• Conditions: Aneurysmal Subarachnoid Heamorrhage; Nontraumatic Subarachnoid Haemorrhage

• Registration Number: NCT01670838
• Lead Sponsor: Kuopio University Hospital

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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-08-19
• Study First Submitted QC: 2012-08-21
• Study First Posted: 2012-08-22
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-14
• Last Update Posted: 2018-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of cardiac failure and the impact of cardiac problems on morbidity	6 months	The aims of the study are: 1. to document the incidence of myocardial dysfunction; 2. to find the predictive factors of myocardial dysfunction as determined by the severity aneurysmal bleeding (Hunt and Hess-grading, Glasgow coma score, Fisher scale) and demographic factors; 3. to find predictive factors for myocardial dysfunction as determined by laboratory findings, electrocardiography, and echocardiography; 4. to describe heart rate variability; 5. to assess the impact of all cardiac problems on morbidity

Trial Locations

Locations (3)

Inselspital Bern; 🇨🇭 Bern, Switzerland

Kuopio University Hospital; 🇫🇮 Kuopio, Finland

Turku University Hospital; 🇫🇮 Turku, Finland