Management of Compartment Syndrome With Ultrafiltration

NCT00022815 | Completed Phase 1

• 2 other identifiers: R44AR044591NIAMS-062
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Compartment Syndrome

Keywords

Compartment syndrome; Tissue ultrafiltration; Reperfusion injury; Ischemia

Interventions

Tissue ultrafiltration DEVICE

Eligibility Criteria

• Age: 14 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient has a closed or open Gustilo grade I, grade II, or grade IIIa tibial shaft fracture that is going to be treated with surgical stabilization under general anesthesia.
• An open fracture must have sufficient skin for wound coverage.
• The patient has a single tibial fracture.
• The patient is mentally alert and able to sign his or her own consent form.
• Patient is at least 60" in height.
• Patient is between 14 and 80 years of age.

You may not qualify if:

• The patient previously had a fracture in the same leg.
• The patient has a Gustilo grade IIIb open fracture.
• The patient has a Tscherne grade II or Tscherne grade III injury.
• Patients with evidence of compartment syndrome at the time of admission.
• The patient is obese, with body mass index greater than 35 (km/m2).
• Have medical condition(s) that precludes use of indwelling catheters for 24 hours, such as dermatologic conditions or immunological deficits.
• Have co-morbidities that may place the patient at risk of hypotension (e.g., significant blood loss, heart failure, significant chest or abdominal trauma, septicemia, or massive soft tissue trauma).

Sponsors & Collaborators

• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): lead

Study Sites (1)

Hennepin County Medical Center

Minneapolis, Minnesota, 55405, United States

Location

MeSH Terms

Conditions

Compartment Syndromes; Reperfusion Injury; Ischemia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• William Fowler

  Twin Star Medical, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 14, 2001
• First Posted: August 16, 2001
• Study Start: June 1, 2002
• Primary Completion: June 1, 2004
• Study Completion: June 1, 2004
• Last Updated: April 14, 2008

Record last verified: 2008-04

Locations

US (1)