Clinical Trial: An Analysis of Cytokine Concentration in Open Abdominal Closure of Trauma Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: An Analysis of Cytokine Concentration in Open Abdominal Closure of Trauma Patients

Brief Summary: The purpose of this study is to compare the pro-inflammatory and anti-inflammatory cytokines, protein content, and white blood cell (WBC) count present in the peritoneal fluid and plasma of trauma patients who undergo one of two different methods of open abdominal closure. Following analysis of the peritoneal fluid and serum samples, comparison of the results between the two groups will be completed and correlated with the overall organ function.

Detailed Summary:

Elevated pro and anti-inflammatory cytokines have been implicated as markers for multi-system organ failure (MOF) and death in trauma patients. Abdominal surgery can raise the levels of these cytokines and may lead to elevated plasma levels of these inflammatory cytokines possibly leading to worsening patient prognosis. Patients in whom open abdominal closure is required are often the sickest of trauma patients. Two different temporary abdominal closure techniques are generally used at the Presley Memorial Trauma Center, one using the blue towel: vacuum pack technique and one using the commercially available ABThera vacuum device from Kinetic Concepts, Inc (KCI). This study is being conducted to determine if the ABThera temporary closure technique removes a greater amount of cytokines from the abdominal cavity possibly lessening the amount of systemic or plasma cytokines and thus decreasing the incidence of MOF and death in this very ill population of patients. Additionally, this study is being conducted to determine if the white blood cell count may be lower in patients with the least cytokine values and to also investigate protein loss in these patients. The depletion of body stores of protein due to an open abdomen has great nutritional and, therefore, healing implications.

Enrollment will include 40 subjects meeting eligibility criteria into this study. The study population will include 20 patients who were temporarily closed using the ABThera device and 20 who were temporarily closed using the blue towel: vacuum pack technique. Peritoneal fluid and blood will be collected in eligible subjects immediately upon arrival to the ICU following surgery and at 12, 24, 48 and 72 hours following placement. Peritoneal fluid will be collected from the drainage system into a Lukens trap. Blood will be collected from an existing intravenous or arterial line. The peritoneal fluid w
Sponsor: University of Tennessee

Current Primary Outcome: Change in cytokine levels over 72 hours in peritoneal fluid in each enrolled subject [ Time Frame: Change in cytokine levels over 72 hours following placement of the device ]

Fluid will be obtained from the collection portion of the device into a Lukens trap. Fluid will be centrifuged into separate specimens and frozen at -80 degrees centigrade prior to analysis. Specimens will be analyzed using standard laboratory process.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in white blood cell count in peritoneal fluid over 72 hours following placement of the device in each enrolled subject [ Time Frame: Serial samples obtained over 72 hours following placement of the device ]
    Fluid will be obtained from the collection portion of the device into a Lukens trap. Fluid will be centrifuged into separate specimens and frozen at -80 degrees centigrade prior to analysis. Specimens will be analyzed using standard laboratory process.
  • Change in protein content in peritoneal fluid over 72 hours following placement of the device in each enrolled subject [ Time Frame: Serial samples obtained over 72 hours following placement of the device ]
    Fluid will be obtained from the collection portion of the device into a Lukens trap. Fluid will be centrifuged into separate specimens and frozen at -80 degrees centigrade prior to analysis. Specimens will be analyzed using standard laboratory process.
  • Change in cytokine levels in serum samples over 72 hours following placement of the device in each enrolled subject [ Time Frame: Serial samples obtained over 72 hours following placement of the device ]
    Serum samples will be collected for an indwelling intravenous catheter, centrifuged into separate specimens and frozen for cytokine/inflammatory marker analysis. Specimens will be analyzed using standard laboratory process.


Original Secondary Outcome: Same as current

Information By: University of Tennessee

Dates:
Date Received: March 24, 2016
Date Started: March 2010
Date Completion:
Last Updated: April 4, 2016
Last Verified: March 2016