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Completed

NCT Number: NCT02806492

Parameters of Cerebral Perfusion

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UMC Utrecht

Utrecht, 3584CX, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

50-100ug phenylephrine before CPB

Other

In this intervention we will administer 50-100 μg phenylephrine to the patient before CPB is started. This intervention will take place when the patient shows hypotension (MAP <60mmHg, according to protocol22). Because of the increase in PVR there will be a baroreceptor-reflex-mediated decrease in CO. On-line, we will quantify the percentage decrease in systemic blood flow (i.e. CO) by using the Modelflow algoritm incorporated in a non-invasive beat-to-beat finger blood pressure monitor. This will allow us to obtain a reference for the decrease in CO to use in the next interventions. Our hypothesis is that CO will decrease because of the baroreceptor-reflex. During this intervention NIRS and TCD MCA will be recorded.

50-100ug phenylephrine during CPB

Other

In this intervention we will induce only 1 component of the changes at intervention (1), being the increase in MAP of approximately 20 mmHg by administrating 50-100 μg phenylephrine. The CPB enables us to maintain a constant CO and thus eliminating the baroreceptor-reflex. During this intervention NIRS and TCD MCA will be recorded.

decreasing CPB flow

Other

With this intervention we will only create a change in CO, which enables us to eliminate the effect of blood pressure. We will modify CPB flow to achieve the CO decrease (in %) measured at intervention (1) meaning: pre-CPB after the bolus of 50-100 μg phenylephrine. In the case of unexpected increase (in %) of CO measured at intervention (1), we will still decrease CPB flow so we will be able to analyse decrease as well as increase in CPB flow. During this intervention NIRS and TCD MCA will be recorded.

Decreasing CPB flow AND 50-100ug phenylephrine

Other

In this intervention we will simulate the 'normal' physiological state when administering phenylephrine. We will modify CPB flow to achieve the percentage change CO as observed during intervention (1) as well as administrate 50-100 μg phenylephrine. We expect to see similar outcomes as in intervention (1). During this intervention NIRS and TCD MCA will be recorded.

Increasing CPB flow

Other

In this last intervention we will create an increase in MAP without using phenylephrine but only by increasing CO. This enables us to eliminate a possible direct α1-adrenergic effect on the cerebral vasculature. MAP will be raised approximately 20 mmHg by increasing CPB flow 20%. During this intervention NIRS and TCD MCA will be recorded.

Primary outcomes

  1. regional cerebral oxygen saturation

    Time frame: During surgery

  2. mean velocity of blood flow of the middle cerebral artery

    Time frame: During surgery

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Registry information

Official study title

Blood Pressure or Cardiac Output - the Influence on Cerebral Perfusion During Cardiopulmonary Bypass

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 20, 2016
Registry last updated
Jun 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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