Evaluation of FDY-5301 in Major Trauma Patients in ICU (NCT04430283) | Clinical Trial Compass
TerminatedPhase 2
Evaluation of FDY-5301 in Major Trauma Patients in ICU
Stopped: The study was terminated because of difficulty identifying patients that met the inclusion criteria, as well as logistical difficulties in opening clinical ICU study sites.
United States8 participantsStarted 2021-09-20
Plain-language summary
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of FDY-5301 compared to placebo in major trauma ICU patients at risk of intensive care unit acquired weakness (ICUAW)
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age 18-75 years
✓. Major trauma defined as:
✓. thoracic and/or abdominal and/or pelvic injury
✓. necessitating admission to ICU with ventilation anticipated for at least 24 hrs
✓. hemorrhagic shock defined as systolic blood pressure (SBP) \<90 mmHG requiring blood transfusion or base deficit of at least 6mEq/L pre-hospital arrival or within one hour after hospital arrival
✓. IRB/IEC-approved consent obtained within 48 hours of first hospital arrival time (i.e., in case of transfers, use time of arrival to first hospital immediately post injury)
Exclusion criteria
✕. Likely to die within 48 hrs from time of screening
✕. Any neurological condition that is perceived at the time of hospital admission as an immediate threat to life or incompatible with good functional recovery and where early limitation or withdrawal of therapy is being considered. For example:
✕. Evidence of nonreversible spinal cord injury
✕. Bilateral femoral fractures
✕. Women who are pregnant or breastfeeding. Women of reproductive potential must have a negative serum pregnancy test prior to randomization.
✕. Known thyroid disease or thyroid disorder, including subjects on thyroid hormone replacement therapy at the time of randomization
What they're measuring
1
Chelsea Critical Care Physical Assessment Tool
Timeframe: Day 10 or hospital discharge, whichever occurs first.
2
Organ Dysfunction Total Time to Recovery
Timeframe: Day 28 or hospital discharge, whichever occurs first.