Injuries, Acute Brain, Severe Trauma Brain Injury (sTBI), Subarachnoid Hemorrhage, Aneurysmal
Conditions
Brief summary
This study will be targeting patients suffering from acute brain injury (ABI), including those with severe trauma brain injury (sTBI) and those with aneurysmal sub arachnoid hemorrhage (aSAH). This clinical study is an open-label, non-randomized, single-center, exploratory metabolic study. The primary objective is to determine changes from baseline (before enteral administration of Peptamen AF) in plasma and brain extracellular levels of MCFAs and Ketone bodies in sTBI patients upon Peptamen AF nutritional support.
Interventions
DIETARY_SUPPLEMENTPeptamen AF
Each patient will receive Peptamen AF throughout the trial.
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Comatose patients (defined by an initial Glasgow Coma Scale (GCS) \< 9) following sTBI or aSAH. * Female or male, aged \>18. * Abnormal head CT-Scan (contusions, hematoma). * Intracranial monitoring with CMD, \[PbtO2\] and \[ICP\] probes as part of standard of care. * Written informed consent from an independent physician (not associated to the research project) who provides medical follow-up and defends patient's interests. * Written informed consent from patient relative/legal representative confirming the presumed patient willingness to participate in the study
Exclusion criteria
* Signs of brain death or expected brain death within 48h. * Pregnancy. * Hemodynamic instability (circulatory shock, requiring vasopressors). * Renal or liver insufficiency . * Chronic intestinal disease. * Patients requiring parenteral nutrition . * Currently participating or having participated in another clinical trial during the month preceding the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes from Baseline of plasma and brain extracellular (CMD fluid) levels of MCFAs and KBs in sTBI upon Peptamen AF nutritional support | Over 7 days |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in plasma and brain extracellular levels of MCFAs and KBs in all patients | Over 7 days (not necessarily at stable EN). |
| As part of standard care, monitoring of intra-cerebral physiologic and metabolic variables and correlation with brain MCFAs and KBs levels in all patients | Over 7 days |
| Changes from baseline of plasma and brain extracellular levels of MCFAs and KBs in aSAH patients | After at least 2 consecutive days of stable enteral nutrition |
| To correlate MCFAs and KBs levels in CMD, plasma and cerebral spinal fluid in all patients | Over 7 days |
| Evaluation of the time to reach two days of stable nutrition in all patients | Over 7 days |
| Changes from baseline in cerebrospinal fluid of MCFAs and KBs concentrations in all patients with extra-ventricular drainage (EVD) as part of standard care | Over 7 days |
Countries
Switzerland
Outcome results
None listed