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Clinical Trials/NCT02916069
NCT02916069UnknownNot Applicable

The Impact Multi Modal Brain Monitoring on Patient Out Come After Adult Cardiac Surgery

Assiut University2 sites in 1 country1,200 target enrollmentStarted: September 2016Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
1,200
Locations
2
Primary Endpoint
S100 protein
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Multimodal brain monitoring is feasible and can be used in formulating therapeutic strategies during cardiac surgery. Such monitoring may help to improve patient outcome and to reduce costs after cardiac surgery with CPB.

Detailed Description

The aim of this study is to use a combination of brain monitoring {Nearinfrared Spectroscopy (NIRS), Transcranial Doppler (TCD), bispectral index (BIS)} to formulate therapeutic strategies based on these monitors and to evaluate the impact on patient outcome.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Screening
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Elective cardiac surgery with cardiopulmonary bypass
  • •Valve replacement
  • •Coronary artery bypass

Exclusion Criteria

  • •Emergency surgery
  • •Renal impairment
  • •Diabetes Mellitus

Outcomes

Primary Outcomes

S100 protein

Time Frame: up to 24 hours

S100 protein (marker of brain injury)

Secondary Outcomes

  • Major neurological out come as stoke(up to 30 days after surgery)
  • Mini-mental state examination(up to 30 days after surgery)
  • Duration of mechanical ventilation(up to 30 days after surgery)
  • Hospital stay(up to 30 days after surgery)
  • Western perioperative neurological scale(up to 30 days after surgery)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr Mohamed Shaaban Ali, PhD, MD

Associate Professor (Anesthesiology and Critical Care)- College of Medicine-Assiut University

Assiut University

Study Sites (2)

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