Recruiting PHASE2 Traumatic Brain Injury

Compares treatment options for Traumatic Brain Injury

Official title Feasibility and Safety of Targeting Neutral vs Liberal Fluid Balance in Traumatic Brain Injured Patients- LIMIT-TBI Trial

ClinicalTrials.gov ID: NCT07625995

What this study is testing

What it's testing
The LIMIT-TBI trial is a multicenter, international, randomized, phase II clinical trial designed to evaluate the feasibility and safety of targeting a neutral fluid balance compared to standard care in critically ill adult patients with traumatic brain injury (TBI). Fluid therapy is a cornerstone of TBI management, but optimal fluid balance remains uncertain, with both fluid overload and restriction potentially leading to adverse outcomes.
  • Phase 2: a mid-size study of how well it works
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • Adult patients with traumatic brain injury (isolated or associated with extracranial injuries), with or without intracranial pressure monitoring
  • Admission to the intensive care unit
  • Age \>18 years
  • Enrollment within 48 hours after ICU admission

You likely can't join if

  • Enrollment in another clinical trial not approved for co-enrollment
  • Pregnancy or suspected pregnancy
  • Concomitant hemorrhagic shock expected to require surgical treatment within 24 hours from inclusion or requiring massive transfusion protocol
  • Hemodynamic instability at ICU admission, defined as heart rate \>120 beats/min and systolic arterial pressure \ 0.5 mcg/kg/min) or any inotropic...
  • Need for continuous venovenous hemodiafiltration (CVVHDF) at admission
  • Expected survival \<48 hours

The study team makes the final eligibility decision.

Where it's taking place

  • Brussels, Belgium
  • Genova, Italy
  • Roma, Italy

Compensation & support

Compensation mentioned.

ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.

Questions & answers

Do participants get paid in this trial?

This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Brussels, Belgium; Genova, Italy; Roma, Italy. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.