An Analysis of Cytokine Concentration in Open Abdominal Closure of Trauma Patients

Abdominal Trauma Clinical Trial

Official title:

An Analysis of Cytokine Concentration in Open Abdominal Closure of Trauma Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02728609
• Other study ID #: 10-00739-FB
• Status: Completed
• Phase: N/A
• First received: March 24, 2016
• Last updated: April 4, 2016
• Start date: March 2010
• Est. completion date: April 2014

Study information

• Verified date: March 2016
• Source: University of Tennessee
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

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 will be centrifuged, separated, and frozen at -80 degrees centigrade for analysis of cytokine/inflammatory markers, protein, and WBC count. The blood specimens will be centrifuged, separated, and frozen for cytokine/inflammatory marker analysis. Chemistry and hematology values completed as standard of care will be collected from the hospital chart along with general demographics, description of injuries, treatment modalities, and outcomes.

The first samples of blood and peritoneal fluid will be obtained immediately on arrival in the ICU when other labs are being drawn as standard of care. These samples will be put aside until consent can be obtained from the legally authorized representative or the subject himself. If the research subject and/or his legally authorized representative decide that the subject should not participate in the study, the sample will be destroyed and no additional study procedures will be obtained. If the legally authorized representative is not available within 12 hours of the initial specimen and the subject is unable to consider participation within 12 hours of the initial specimens, the subject will not be enrolled into the study, and samples obtained immediately on arrival to the ICU will be destroyed.

After all analyses are completed, comparison of the cytokine levels, WBC count, and protein extraction between the two vacuum methods will be completed and correlated to the patients' overall organ function.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 18 to 75 years of age who have been admitted following abdominal trauma and require open laparotomy

• Those who are closed using either the blue towel: vacuum pack method or the ABThera vacuum device

• Those who can be enrolled within 12 hours of placement of temporary abdominal closure

Exclusion Criteria:

• Those who cannot give informed consent and do not have a Legally Authorized Representative available

• Prisoners are excluded

• Pregnant women are excluded

• Those under 18 years of age and older than 75 years of age

• Those who do not require temporary abdominal closure using either the blue towel:

vacuum pack technique or with the ABThera vacuum device.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Abdominal Injuries
• Abdominal Trauma
• Wounds and Injuries

Intervention

Device:
• ABThera vacuum device
This intervention uses a commercially available vacuum device to temporarily close the abdomen following surgery.
• Blue towel: vacuum pack device
This intervention uses operating room towels and the application of suction to temporarily close the abdomen following surgery.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Tennessee	Kinetic Concepts, Inc.

References & Publications (3)

Kowal-Vern A, Ortegel J, Bourdon P, Chakrin A, Latenser BA, Kimball D, Casey LC. Elevated cytokine levels in peritoneal fluid from burned patients with intra-abdominal hypertension and abdominal compartment syndrome. Burns. 2006 Aug;32(5):563-9. — View Citation

Liener UC, Brückner UB, Knöferl MW, Steinbach G, Kinzl L, Gebhard F. Chemokine activation within 24 hours after blunt accident trauma. Shock. 2002 Mar;17(3):169-72. — View Citation

Spindler-Vesel A, Wraber B, Vovk I, Kompan L. Intestinal permeability and cytokine inflammatory response in multiply injured patients. J Interferon Cytokine Res. 2006 Oct;26(10):771-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cytokine levels over 72 hours in peritoneal fluid in each enrolled subject	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 over 72 hours following placement of the device	No
Secondary	Change in white blood cell count in peritoneal fluid over 72 hours following placement of the device in each enrolled subject	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.	Serial samples obtained over 72 hours following placement of the device	No
Secondary	Change in protein content in peritoneal fluid over 72 hours following placement of the device in each enrolled subject	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.	Serial samples obtained over 72 hours following placement of the device	No
Secondary	Change in cytokine levels in serum samples over 72 hours following placement of the device in each enrolled subject	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.	Serial samples obtained over 72 hours following placement of the device	No