Management of Compartment Syndrome With Ultrafiltration
Condition: Compartment Syndrome
MeSH terms: Compartment Syndromes; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will test the safety of a new treatment method called tissue ultrafiltration. We
      will test this method in the treatment of compartment syndrome, a condition that occurs when
      pressure within the muscles builds to dangerous levels. In the legs and other parts of the
      body, a tough, stiff membrane covers groups of muscles and the nerves and blood vessels that
      run next to and through them. The entire unit is called a compartment. The causes of
      compartment syndrome include traumatic leg injuries and loss of blood supply. In tissue
      ultrafiltration, a doctor places hollow probes, or catheters, directly into the muscle
      compartment in the injured area of the lower leg. The probes remove fluid from the
      compartment (extra fluid can cause increased pressure).

      We will do an initial safety study in a group of patients who have had surgery for a broken
      tibia (the inner, larger bone of the lower leg) and are at high risk for developing
      compartment syndrome. The goals of this initial study are to show that inserting tissue
      ultrafiltration catheters in the muscle compartment is safe and can be done repeatedly
      without problems; to show that tissue ultrafiltration can be used to monitor the biochemical
      environment inside tissues; and to show that the catheter apparatus provides an accurate
      measurement of pressure in the compartment.
    

Detailed description: 
      The human clinical trials are organized as a series of consecutive studies designed to
      demonstrate the safety and efficacy of ultrafiltration in the management of compartment
      syndrome (CS). The first study is a cohort study of patients with tibial shaft fractures that
      will test the safety of the catheters as well as demonstrate that ultrafiltration fibers
      provide an improved method for monitoring myofascial compartment physiology. The goals of
      this study are to (1) demonstrate that inserting ultrafiltration (UF) catheters is safe and
      reproducible; (2) show that CSUF allows for biochemical assessment of cellular function; and
      (3) show that the CSUF apparatus provides an accurate measurement of intracompartmental
      pressure.

      The study population will consist of 10 patients with closed or open Gustilo grade I, grade
      II, or grade IIIa tibial shaft fractures that require surgical stabilization. We will recruit
      patients for the study at the study centers. Data collected during this study will be
      numerical values for the biochemical measurements and for the intramuscular pressure (IMP)
      measurements. We will compare the CSUF system values for intramuscular pressure with IMP
      measured with a Stryker device. Finally, we will correlate serial changes in the biochemical
      measures to any changes in IMP. The metabolic assay will show increased UF levels compared to
      serum levels.

      We will consider fasciotomy when the IMP is within 30 mmHg of the patient's diastolic blood
      pressure, or when the clinical examination of the patient demands. We will make repeat IMP
      measurements at the time of fasciotomy and record the interval to and reasons for fasciotomy.

      Following the operative stabilization of the tibial fracture and before the final closure of
      any traumatic wounds, we will insert multiple UF catheters into the anterior, lateral, and
      posterior (superficial and deep) compartments of the leg. Techniques used for catheter
      insertion will be similar to existing methods for the insertion of drainage catheters and we
      do not anticipate any specific difficulties with this step.

      To measure intramuscular pressure, we will connect one of the catheters designed for this
      purpose to a standard pressure transducer and will use it to monitor intracompartmental
      pressure (IMP) in real-time. In addition, we will use a standard wick catheter, inserted
      separately, for control measurements.

      For biochemical measurements, we will analyze samples of the interstitial fluid removed by
      CSUF for levels of creatine phosphokinase (CPK), lactic acid, lactate dehydrogenase (LDH),
      osmolarity, pH, and pO2. We will obtain fluid every 4 hours for up to 48 hours. The assays
      will be performed by standard clinical laboratory techniques.
    

Intervention name(s): Tissue ultrafiltration
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Compartment syndrome; Tissue ultrafiltration; Reperfusion injury; Ischemia