A Phase 2 interventional study of Norepinephrine and Dobutamine and norepinephrine in Severe Traumatic Brain Injury With High Cerebral Pressure, sponsored by University Hospital, Grenoble. Status unknown at 1 site in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-08-17.
Sponsored by University Hospital, Grenoble · Phase 2, Interventional, and Treatment
Severe traumatic brain injury with increased intracranial pressure can lead to decreased cerebral blood flow. Low cerebral blood flow is responsible for secondary lesions, leading to bad prognosis. It is not yet established whether increasing cardiac output in these patients can lead to an increase in cerebral blood flow, although there are some arguments in favor of this hypothesis. The aim of this study is to demonstrate that increasing cardiac output will improve cerebral blood flow in patients with severe traumatic injury and high cerebral pressure.
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's planned enrollment of 20 is below the median of 48 across 1,331 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment for 30 minutes with noradrenaline alone
Drug: Norepinephrine
Treatment with noradrenaline and dobutamine for 30 minutes
Drug: Dobutamine and norepinephrine
Mean blood flow velocity
Mean blood flow velocity averaged on the two middle cerebral arteries (right and left) measured one after after the initiation of treatment. Each velocity is calculated as an average on the 10 last minutes form continuous transcranial doppler monitoring
Time frame: After one hour of treatment
Evolution of brain oxygenation under treatment
Comparison of the brain tissue oxygenation curves (PbrO2) under treatment with and without dobutamine
Time frame: During one hour of treatment
Dobutamine doses
Dobutamine doses required to reach the same cerebral perfusion pressure than noradrenaline alone
Time frame: After one hour of treatment
Resistivity index on renal doppler
Measure of resistivity index on renal doppler after one hour of treatment with and without dobutamine
Time frame: After one hour of treatment
Pulsatility index on renal doppler
Measure of pulsatility index (PI) on renal doppler before and after one hour of treatment with and without dobutamine prediction of cerebral blood flow increase (patients with high initial renal PI)
Time frame: After one hour of treatment
Cardiac output modifications
Comparison of cardiac blood flow modifications under treatment for one hour with and without dobutamine
Time frame: During one hour of treatment
This study is status unknown, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Grenoble