Goal Directed Therapy After Aneurysmal Subarachnoid Haemorrhage

Study Overview
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Brief Summary
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The objective of this study is to determine whether a goal-directed therapy can reduce the incidence of delayed cerebral ischaemia after aneurysmal subarachnoid haemorrhage.

Detailed Description
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The aneurysmal subarachnoid haemorrhage (SAH) is a frequent and dangerous worldwide cause for stroke. A typical complication presents delayed cerebral ischemia as a consequence of cerebral vasospasms, which occurs in 46% of the cases. The Triple-H-therapy (Hypervolaemia, Hypertension and Haemodilution) was favoured to prevent ischaemic complications after vasospasm for a long time. However recently, the focus is mainly on hypertension, and it is recommended to maintain normovolaemia. The debate how to assure normovolaemia is still on going, therefore, this study was designed to examine whether a PiCCO-controlled haemodynamic monitoring and a goal-directed therapy can reduce the incidence of delayed cerebral ischaemia after SAH. The present study is a prospective randomized controlled clinical study. Patients older than 18 years with an aneurysmal SAH will be enrolled. They will be divided into two groups: a control group C and a PiCCO group P. Both groups will be treated according to the current guidelines. In addition, in group P the volume and catecholamine therapy will be controlled by means of PiCCO-controlled monitoring and an algorithm. The primary end point is the number of occurred delayed cerebral ischaemia per patient. Secondary end points are neurological, pulmonary, cardiovascular, renal, and hepatic complications as well as electrolyte and serum glucose disturbance, sepsis, and mortality, length of hospital and intensive care unit stay and the amount of volume and catecholamines administered. All participants are to be contacted three months after discharge, and their health status is to be determined by using the GOS (Glasgow Outcome Scale).

Official Title
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Does a PiCCO-controlled Advanced Haemodynamic Monitoring Improve the Outcome After Aneurysmal Subarachnoid Haemorrhage?

Conditions
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SAH, Aneurysmal Subarachnoid Haemorrhage

Intervention / Treatment
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* Device: PiCCO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aneurysmal Subarachnoid Haemorrhage (SAH) Age ≥ 18 years Exclusion Criteria: traumatic SAH congestive heart failure severe diseases of aorta or aortic valve pregnancy calcium antagonist intolerance

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group P<br>PiCCO-controlled group | Device: PiCCO<br> <br> |
| No Intervention: Group C<br>control group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of occurred delayed cerebral ischaemia (DCI) per patient | a 2 point increase in the score of the NIHSS-scale lasting for at least 8 hours or a ≥ 2-point decrease in the Glasgow Coma Scale (GCS) lasting for at least 8 hours (as signs of a new focal neurological deficit); and/or radiologic signs of cerebral infarction in presence of vasospasm. other causes of neurological aggravation (e.g. hydrocephalus, re-bleeding etc) had to be excluded. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pulmonary and cardiovascular complications |  | 3 months | 
| neurological complications |  | 3 months | 
| renal and hepatic complications |  | 3 months | 
| electrolyte and serum glucose disturbance |  | 3 months | 
| sepsis, and mortality |  | 3 months | 
| length of hospital and intensive care unit stay |  | 3 months | 
| amount of volume and catecholamines administered |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Subarachnoid Haemorrhage (SAH), vasospasm, delayed cerebral ischaemia (DCI), goal directed therapy (GDT), Pulse Contour Cardiac Output (PiCCO)