Multimodal Neuromonitoring During Normothermic Regional Perfusion for Organ Donors Determined Dead by circuLatory Criteria Following Withdrawal of Life Sustaining Measures

Condition(s) studied

Investigational drug(s) / intervention(s)

Neuromonitoring: Neuromonitoring during withdrawal of life sustaining therapies, dying process and during normothermic regional perfusion after death. The neuromonitoring will include: * Invasive intracranial pressure monitoring (Codman) * Bilateral invasive oxygentation monitoring (Licox) * Bilateral invasive blood flow monitoring (Hemedex) * Bilateral invasive EEG monitoring (Nantus) * Cerebral microdialysis * Transcranial doppler (Novosignal) * Jugular bulb oximetry (Edwards) * Surface EEG (Nantus) * Near infrared spectroscopy (Masimo) * Somatosensory and brainstem evoked potentials * Bispectral index (Masimo)

Study summary

The aim of this study is to demonstrate that cerebral blood flow and brain function do not resume after death declaration in organ donors who undergo normothermic regional perfusion to restore organ function following death determination by circulatory criteria, when appropriate safeguards are applied.

To assess the absence of cerebral perfusion and function, investigators will use continuous and comprehensive multimodal neuromonitoring throughout the withdrawal of life-sustaining therapies, the dying process and the NRP procedure.

Eligibility

Primary outcome measure(s)

• Aim 1: Assessment of brain reanimation (restoration of brain circulation and/or function) — One hour prior to withdrawal of life-sustaining therapies, during the dying duration and for 2 hours during normothermic regional perfusion
  To determine the presence or absence of the brain circulation and function during normothermic regional perfusion assessed by intra-parenchymal neuromonitoring, non-invasive neuromonitoring and clinical examination. Reperfusion or regain of brain function during normothermic regional perfusion will be expressed in proportion. Restoration of either cerebral perfusion or neurological function in a patient will be considered a single brain reanimation event. Clinical examination will consist of serial pupillary light reflex assessment and monitoring for respiratory efforts during normothermic regional perfusion. Evidence of brain function will be determined by the presence of rhythmic delta wave activity on electroencephalography, N20 response with somatosensory evoked potentials or presence of brainstem auditory evoked potentials. Restoration of brain circulation will be determined by the presence of cerebral blood flow (\>10mls/100g/min) or brain tissue oxygen tension (\>2mmHg).
• Aim 2: Feasibility of conducting multimodal monitoring — One hour prior to withdrawal of life-sustaining therapies, during the dying duration and for 2 hours during normothermic regional perfusion
  To assess the feasibility of implementing multimodal neuromonitoring in DCD organ donors undergoing normothermic regional perfusion. This will be a descriptive outcome in which investigators will calculate the duration of available data for each modality and compare it with the total observation period. The investigators hypothesized that feasibility will be strong and that \> 80% data variables will be collected for the pre-specified duration in each case.

Trial sites (1)

More University of British Columbia trials in Canada

Other trials for the same condition