Evaluation of the Diagnostic and Therapeutic Value of Tissue Ultrafiltration in Patients at Risk of Acute Compartment Syndrome (ACS)
Abstract
This application proposes a randomized clinical trial (RCT) to validate tissue ultrafiltration (TUF) as means of diagnosing and preventing acute compartment syndrome (ACS) in a manner that can be used in austere environments and in prolonged field care (PFC) situations. The efficacy of TUF will be evaluated in 4 different ways with one primary hypothesis and three secondary hypotheses. TUF is hypothesized to reduce the likelihood of ACS, fasciotomy incidence, intramuscular pressure (IMP), and functional outcomes at 6 months. In addition, exploratory goals are to test the impact of TUF on improving muscle strength and to evaluate the diagnostic performance of serial measurement of biomarkers related to muscle metabolism in the interstitial fluid. Study Design: RCT of 200 patients treated at one of 5 sites comparing standard of care therapy plus TUF to standard of care therapy alone in a cohort of patients at risk for acute compartment syndrome after leg injury. Military Benefit/ Clinical Impact: This proposals goal is to validate a method to diagnose and manage ACS that is ideally suited to PFC. The insertion of TUF catheters that connect to a simple closed suction source could be easily accomplished by a combat medic, allowing for immediate prophylactic therapy. Further, IMP measurements can be obtained, and metabolic monitoring of the limb can be performed. A more precise and confident diagnosis of impending ACS would allow accurate triage of these patients who need urgent surgery, versus continued field care in patients that are stable.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2021
- Accession Number
- AD1162362
Entities
People
- Andrew H. Schmidt
- Renan Castillo
Organizations
- Hennepin Healthcare Research Institute