We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

iNtrAcranial PreSsurE in ICU Intensive Care (ICU) (SynapseICU) (SynapseICU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03257904
Recruitment Status : Not yet recruiting
First Posted : August 22, 2017
Last Update Posted : August 22, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Intracranial pressure (ICP) monitoring is the most common neuromonitoring modality used in neurocritical care (NCCU) around the world. Uncertainties remain around intracranial pressure monitoring both in traumatic and non-traumatic brain injury, and variation in clinical practice of intracranial pressure monitoring exists between neurocritical care units.

The objectives of the study will explore intracranial pressure monitoring variation in practice to prioritise uncertainties in the clinical management of critical care patients with acute brain injury and support further collaborative hypotheses-based prospective studies.


Condition or disease Intervention/treatment
Traumatic Brain Injury Subarachnoid Hemorrhage Intracerebral Hemorrhage Procedure: intracranial pressure monitoring

Detailed Description:

Intracranial pressure (ICP) monitoring is the most common neuromonitoring modality used in neurocritical care (NCCU) around the world. Uncertainties remain around intracranial pressure monitoring both in traumatic and non-traumatic brain injury, and variation in clinical practice of intracranial pressure monitoring monitoring exists between neurocritical care units.

The objectives of the study will explore intracranial pressure monitoring variation in practice to prioritise uncertainties in the clinical management of critical care patients with acute brain injury and support further collaborative hypotheses-based prospective studies.

Sample Size: This international prospective observational study aims to recruit >1000 patients in coma after acute traumatic and non-traumatic brain damage admitted to >100 Intensive Care Units.

Inclusion Criteria:

  • Acute brain injury (ABI) admitted to ICU following:

    1. Hemorrhagic stroke, including intracerebral hematoma and subarachnoid haemorrhage,
    2. Traumatic brain injury (penetrating and non-penetrating).
  • Age >16 years old
  • Motor score of the Glasgow Coma Scale on admission to ICU <5

Exclusion Criteria:

  • Acute brain injury due to causes other than the one specified in the inclusion criteria.
  • Age <16 years old
  • Motor score of the Glasgow Coma Scale on admission to ICU >5

Outcome measures:

Glasgow Outcome Score-Extended at 3-6 months

Endpoint:

The primary endpoint of the study is the exploration of the effect size of the variation in clinical practice around intracranial pressure monitoring in acute brain injury patients.

Screening and recruitment: 12 weeks at each centre.

Follow-up: outcome measures will be collected at 3-6 months.

Duration of study: 2 years.

The SYNAPSE-ICU study is partly funded by ESICM (ESICM Trials Group Portfolio).


Study Design

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: International Prospective Observational StudY on iNtrAcranial PreSsurE in Intensive Care (ICU) (SynapseICU)
Anticipated Study Start Date : January 2018
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Intervention Details:
    Procedure: intracranial pressure monitoring
    measurement of intracranial pressure

Outcome Measures

Primary Outcome Measures :
  1. Long-term outcome measures of neurological disability [ Time Frame: 6 months ]

    Extended Glasgow Outcome Scale score

    Long-term outcome measures of neurological disability

    Mortality/Disability



Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Haemorrhagic stroke, including intracerebral hematoma and subarachnoid haemorrhage, Traumatic brain injury
Criteria

Inclusion Criteria:

  • Acute brain injury (ABI) admitted to ICU following
  • Haemorrhagic stroke, including intracerebral hematoma and subarachnoid haemorrhage
  • Traumatic brain injury (penetrating and non-penetrating)
  • Age >16 years old Motor score of the Glasgow Coma Scale on admission to ICU <5

Exclusion Criteria:

  • Acute brain injury due to causes other than the one specified in the inclusion criteria
  • Age < 16
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03257904


Contacts
Contact: Giuseppe Citerio +390392334316 gciterio@gmail.com
Contact: Lara Prisco +44 7901 192056 priscolara@gmail.com

Sponsors and Collaborators
University of Milano Bicocca
European Society of Intensive Care Medicine
Investigators
Principal Investigator: Giuseppe Citerio University Milano Bicocca
More Information

Publications:
Le Roux P, Menon DK, Citerio G, Vespa P, Bader MK, Brophy GM, Diringer MN, Stocchetti N, Videtta W, Armonda R, Badjatia N, Böesel J, Chesnut R, Chou S, Claassen J, Czosnyka M, De Georgia M, Figaji A, Fugate J, Helbok R, Horowitz D, Hutchinson P, Kumar M, McNett M, Miller C, Naidech A, Oddo M, Olson D, O'Phelan K, Provencio JJ, Puppo C, Riker R, Robertson C, Schmidt M, Taccone F; Neurocritical Care Society; European Society of Intensive Care Medicine. Consensus summary statement of the International Multidisciplinary Consensus Conference on Multimodality Monitoring in Neurocritical Care : a statement for healthcare professionals from the Neurocritical Care Society and the European Society of Intensive Care Medicine. Intensive Care Med. 2014 Sep;40(9):1189-209. doi: 10.1007/s00134-014-3369-6. Epub 2014 Aug 20.

Responsible Party: Giuseppe Citerio, MD, Professor, University of Milano Bicocca
ClinicalTrials.gov Identifier: NCT03257904     History of Changes
Other Study ID Numbers: SynapseICU
First Posted: August 22, 2017    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Giuseppe Citerio, MD, University of Milano Bicocca:
intracranial pressure

Additional relevant MeSH terms:
Brain Injuries
Hemorrhage
Brain Injuries, Traumatic
Subarachnoid Hemorrhage
Cerebral Hemorrhage
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases