Goal Directed Therapy After Aneurysmal Subarachnoid Haemorrhage

SAH Clinical Trial

— PiSAH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01832389
• Other study ID #: PiSAH
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: December 2016

Study information

• Verified date: March 2019
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: December 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysmal Subarachnoid Haemorrhage
• Hemorrhage
• SAH
• Subarachnoid Hemorrhage

Intervention

Device:
• PiCCO

Locations

Country	Name	City	State
Germany	Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München	München

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Suarez JI, Tarr RW, Selman WR. Aneurysmal subarachnoid hemorrhage. N Engl J Med. 2006 Jan 26;354(4):387-96. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	pulmonary and cardiovascular complications		3 months
Secondary	neurological complications		3 months
Secondary	renal and hepatic complications		3 months
Secondary	electrolyte and serum glucose disturbance		3 months
Secondary	sepsis, and mortality		3 months
Secondary	length of hospital and intensive care unit stay		3 months
Secondary	amount of volume and catecholamines administered		3 months