Neutral Versus Liberal fLuId In Traumatic Brain Injury: a Randomised Controlled Trial

Launched by UNIVERSITA DEGLI STUDI DI GENOVA · Aug 6, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how different amounts of fluids given to patients with traumatic brain injuries (TBI) can affect their recovery. Specifically, it compares a "neutral" approach, where patients receive just enough fluids to maintain a normal balance, to a "liberal" approach, which involves giving larger amounts of fluids. The goal is to see which method is safer and more effective for people in the intensive care unit (ICU) after experiencing a TBI.

To participate in this trial, patients must be adults over 18 years old who have been admitted to the ICU within 48 hours of their injury. They should have a TBI, either alone or along with other injuries, and may need or not need special monitoring of pressure in their brain. However, individuals who are pregnant, those who are extremely unstable or severely injured, or those already participating in another clinical trial cannot take part. Participants will receive specific fluid treatments based on the trial's guidelines, and throughout the study, their health will be closely monitored to ensure their safety. This research is important because it aims to improve care for patients with severe brain injuries.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adult patients with TBI (isolated or with extracranial injuries, with and without ICP monitoring)
• • Admitted to intensive care unit
• • Age \>18 years
• • Enrolment \<48h after ICU admission
• Exclusion Criteria:
• • Enrolled in another clinical trial that is unapproved for co-enrolment
• • Pregnant or suspected pregnancy
• • Concomitant hemorrhagic shock expected to require surgical treatment in the following 24h from inclusion or requiring polytransfusions (\> 6 blood products or massive transfusion protocol)
• • Hemodynamic instability (HR \> 120 despite fluid resuscitation of at least 1 liter, and systolic blood pressure \< 90 mmHg) at the ICU admission requiring high dosage of norepinephrine (\> 0.5 mcg/kg/min) or inotropes (any dose)