Parameters of Cerebral Perfusion

Not Applicable

Completed

• Conditions: Cerebral Perfusion; Cerebral Oxygenation; Cardiopulmonary Bypass
• Interventions: Other: 50-100ug phenylephrine before CPB; Other: 50-100ug phenylephrine during CPB; Other: decreasing CPB flow; Other: Decreasing CPB flow AND 50-100ug phenylephrine; Other: Increasing CPB flow

• Registration Number: NCT02806492
• Lead Sponsor: UMC Utrecht

Brief Summary

The purpose of this study is to determine whether cerebral blood flow and cerebral tissue oxygenation is most dependent on cardiac output or on mean arterial pressure in patients undergoing cardiac surgery with the use of cardiopulmonary bypass.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-06-15
• Study First Submitted QC: 2016-06-15
• Study First Posted: 2016-06-20
• Primary Completion: 2017-03-17
• Study Completion: 2017-03-17
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-07
• Last Update Posted: 2017-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Undergoing cardiopulmonary bypass for CABG a
• having an appropriate temporal bone window for reliable TCD monitoring
• needing pharmacological intervention because of hypotension before going on CPB.

Exclusion Criteria

• requiring hypothermia during surgery
• requiring emergency surgery
• contraindication for phenylephrine,
• having known brain pathology (e.g. Cerebral Vascular Accident (CVA) or increased intracranial pressure
• having a history of severe carotid artery stenosis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient for cardiac surgery	Decreasing CPB flow AND 50-100ug phenylephrine	All patient undergo the 5 different intervention in a randomised matter.
Patient for cardiac surgery	Increasing CPB flow	All patient undergo the 5 different intervention in a randomised matter.
Patient for cardiac surgery	50-100ug phenylephrine before CPB	All patient undergo the 5 different intervention in a randomised matter.
Patient for cardiac surgery	50-100ug phenylephrine during CPB	All patient undergo the 5 different intervention in a randomised matter.
Patient for cardiac surgery	decreasing CPB flow	All patient undergo the 5 different intervention in a randomised matter.

Primary Outcome Measures

Name	Time	Method
regional cerebral oxygen saturation	During surgery
mean velocity of blood flow of the middle cerebral artery	During surgery

Trial Locations

Locations (1)

UMC Utrecht; 🇳🇱 Utrecht, Netherlands