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Clinical Trials/NCT02916069
NCT02916069
Unknown
Not Applicable

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

Assiut University1 site in 1 country1,200 target enrollmentSeptember 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intraoperative Neurophysiological Monitoring
Sponsor
Assiut University
Enrollment
1200
Locations
1
Primary Endpoint
S100 protein
Last Updated
8 years ago

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.

Registry
clinicaltrials.gov
Start Date
September 2016
End Date
May 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

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

Eligibility Criteria

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)

Study Sites (1)

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