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Goal Directed Therapy After Aneurysmal Subarachnoid Haemorrhage (PiSAH)

Primary Purpose

Aneurysmal Subarachnoid Haemorrhage, SAH

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
PiCCO
Sponsored by
Technical University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aneurysmal Subarachnoid Haemorrhage focused on measuring Subarachnoid Haemorrhage (SAH), vasospasm, delayed cerebral ischaemia (DCI), goal directed therapy (GDT), Pulse Contour Cardiac Output (PiCCO)

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Group P

Group C

Arm Description

PiCCO-controlled group

control group

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

pulmonary and cardiovascular complications
neurological complications
renal and hepatic complications
electrolyte and serum glucose disturbance
sepsis, and mortality
length of hospital and intensive care unit stay
amount of volume and catecholamines administered

Full Information

First Posted
October 29, 2012
Last Updated
March 11, 2019
Sponsor
Technical University of Munich
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1. Study Identification

Unique Protocol Identification Number
NCT01832389
Brief Title
Goal Directed Therapy After Aneurysmal Subarachnoid Haemorrhage
Acronym
PiSAH
Official Title
Does a PiCCO-controlled Advanced Haemodynamic Monitoring Improve the Outcome After Aneurysmal Subarachnoid Haemorrhage?
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technical University of Munich

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aneurysmal Subarachnoid Haemorrhage, SAH
Keywords
Subarachnoid Haemorrhage (SAH), vasospasm, delayed cerebral ischaemia (DCI), goal directed therapy (GDT), Pulse Contour Cardiac Output (PiCCO)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group P
Arm Type
Active Comparator
Arm Description
PiCCO-controlled group
Arm Title
Group C
Arm Type
No Intervention
Arm Description
control group
Intervention Type
Device
Intervention Name(s)
PiCCO
Primary Outcome Measure Information:
Title
number of occurred delayed cerebral ischaemia (DCI) per patient
Description
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.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
pulmonary and cardiovascular complications
Time Frame
3 months
Title
neurological complications
Time Frame
3 months
Title
renal and hepatic complications
Time Frame
3 months
Title
electrolyte and serum glucose disturbance
Time Frame
3 months
Title
sepsis, and mortality
Time Frame
3 months
Title
length of hospital and intensive care unit stay
Time Frame
3 months
Title
amount of volume and catecholamines administered
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bettina Jungwirth, MD
Organizational Affiliation
Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aida Anetsberger, MD
Organizational Affiliation
Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München
City
München
ZIP/Postal Code
81675
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
16436770
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.
Results Reference
background
PubMed Identifier
35357219
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.
Results Reference
derived
PubMed Identifier
32640940
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. Erratum In: Stroke. 2020 Sep;51(9):e272.
Results Reference
derived

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Goal Directed Therapy After Aneurysmal Subarachnoid Haemorrhage

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