Goal Directed Therapy After Aneurysmal Subarachnoid Haemorrhage

Not Applicable

Completed

• Conditions: Aneurysmal Subarachnoid Haemorrhage; SAH
• Interventions: Device: PiCCO

• Registration Number: NCT01832389
• Lead Sponsor: Technical University of Munich

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2012-10-29
• Study Start: 2013-03
• Study First Submitted QC: 2013-04-11
• Study First Posted: 2013-04-16
• Primary Completion: 2015-11
• Study Completion: 2016-12
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-11
• Last Update Posted: 2019-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group P	PiCCO	PiCCO-controlled group

Primary Outcome Measures

Name	Time	Method
number of occurred delayed cerebral ischaemia (DCI) per patient	14 days	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.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München; 🇩🇪 München, Germany