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Completed

NCT Number: NCT01832389

Goal Directed Therapy After Aneurysmal Subarachnoid Haemorrhage

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München

München, 81675, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PiCCO

Device

Primary outcomes

  1. number of occurred delayed cerebral ischaemia (DCI) per patient

    Time frame: 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 outcomes

  1. pulmonary and cardiovascular complications

    Time frame: 3 months

  2. neurological complications

    Time frame: 3 months

  3. renal and hepatic complications

    Time frame: 3 months

  4. electrolyte and serum glucose disturbance

    Time frame: 3 months

  5. sepsis, and mortality

    Time frame: 3 months

  6. length of hospital and intensive care unit stay

    Time frame: 3 months

  7. amount of volume and catecholamines administered

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Official study title

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

Acronym: PiSAH

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Apr 16, 2013
Registry last updated
Mar 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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