Clinical trial NCT01832389: Goal Directed Therapy After Aneurysmal Subarachnoid Haemorrhage
Official title: Does a PiCCO-controlled Advanced Haemodynamic Monitoring Improve the Outcome After Aneurysmal Subarachnoid Haemorrhage?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aneurysmal Subarachnoid Haemorrhage
SAH
Keywords: Subarachnoid Haemorrhage (SAH)
vasospasm
delayed cerebral ischaemia (DCI)
goal directed therapy (GDT)
Pulse Contour Cardiac Output (PiCCO)
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2013-04-16
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: number of occurred delayed cerebral ischaemia (DCI) per patient
timeFrame: 14 days
Secondary outcomes:
measure: pulmonary and cardiovascular complications
timeFrame: 3 months
measure: neurological complications
timeFrame: 3 months
measure: renal and hepatic complications
timeFrame: 3 months
measure: electrolyte and serum glucose disturbance
timeFrame: 3 months
measure: sepsis, and mortality
timeFrame: 3 months
measure: length of hospital and intensive care unit stay
timeFrame: 3 months
measure: amount of volume and catecholamines administered
timeFrame: 3 months
Other outcomes:
Locations:
city: München
country: Germany
facility: Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München
Study officials:
affiliation: Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München
name: Bettina Jungwirth, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München
name: Aida Anetsberger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Suarez JI, Tarr RW, Selman WR. Aneurysmal subarachnoid hemorrhage. N Engl J Med. 2006 Jan 26;354(4):387-96. doi: 10.1056/NEJMra052732. No abstract available.
citation: Althouse AD, Jain SK, Shalaby A, Singh M, Weiss R, Myaskovsky L, Al-Khatib SM, Saba S. Feasibility of a Randomized Clinical Trial of Cardiac Resynchronization Therapy With or Without an Implantable Defibrillator in Older Patients. Circ Arrhythm Electrophysiol. 2022 Apr;15(4):e010795. doi: 10.1161/CIRCEP.121.010795. Epub 2022 Mar 31. No abstract available.
citation: Anetsberger A, Gempt J, Blobner M, Ringel F, Bogdanski R, Heim M, Schneider G, Meyer B, Schmid S, Ryang YM, Wostrack M, Schneider J, Martin J, Ehrhardt M, Jungwirth B. Impact of Goal-Directed Therapy on Delayed Ischemia After Aneurysmal Subarachnoid Hemorrhage: Randomized Controlled Trial. Stroke. 2020 Aug;51(8):2287-2296. doi: 10.1161/STROKEAHA.120.029279. Epub 2020 Jul 9.