Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Peritoneal Vacuum Therapy to Reduce Inflammatory Response From Abdominal Sepsis/Injury (SAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01355094
Recruitment Status : Active, not recruiting
First Posted : May 17, 2011
Last Update Posted : November 3, 2020
Sponsor:
Collaborators:
KCI USA, Inc.
Alberta Health Services
Information provided by (Responsible Party):
Andrew W Kirkpatrick, University of Calgary

Tracking Information
First Submitted Date  ICMJE May 12, 2011
First Posted Date  ICMJE May 17, 2011
Last Update Posted Date November 3, 2020
Study Start Date  ICMJE June 2011
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2011)
Systemic inflammatory marker levels and peritoneal fluid inflammatory marker levels [ Time Frame: admission to dicharge, expected average of hospital stay 4 weeks. ]
Intra-peritoneal and plasma inflammatory mediators will be measured on a treatment allocation basis immediately after initiation of the TAC, and thereafter at 2, 3, 7 and 28 days. The mediators studied will include, but are not limited to TNF-α, IL-1β, IL-6, IL-10, IL-12, and CRP.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2011)
  • Physiological Outcomes [ Time Frame: admission to hospital discharge; expected average of hospital stay 4 weeks. ]
    Determination of the type and activation status of inflammatory cells present in the peritoneal fluid, Measurement of the activation potential of peritoneal fluid, Peritoneal fluid drainage volume, Post-operative fluid balance, Mean 24 hour intra-abdominal pressure (IAP), daily WSACS IAH grading classification, APACHE II score, SOFA score, PaO2/FiO2 ratio, Oxygenation Index, Vasopressor Requirements,RIFLE score, Need for renal replacement therapy, Mean 24 hour lactate level, Mean 24 hour enteral tolerance (if no anastomosis)
  • Global Outcomes [ Time Frame: patients will be followed-up for 6 months ]
    Death, days with fascial closure for the month after admission, ventilator free days for the month after admission, ICU free days from the month after admission, days free of renal replacement therapy.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Peritoneal Vacuum Therapy to Reduce Inflammatory Response From Abdominal Sepsis/Injury
Official Title  ICMJE Peritoneal Vacuum Therapy to Reduce the Systemic Inflammatory Insult From Intraperitoneal Sepsis/Injury/Hypertension: A Randomized Comparison of Baseline Wall Suction Versus the KCI AbThera™ Abdominal Dressing
Brief Summary

This pilot study will evaluate the effectiveness in actively removing the peritoneal fluid through the use of a commercial suction device compared to passive drainage of the same peritoneal fluid drained through standard surgical drains under bulb suction only, in critically ill patients who require an "open abdomen". Both techniques being used, the commercial KCI AbThera™ device and home made "Stampede" VAC system, are currently approved for use in Canada and used in our facility.

The use or non-use of the open abdomen and its relationship to intra-abdominal hypertension (IAH) and the abdominal compartment syndrome (ACS), the level of IAH must be treated and if so how should be treated - remain controversial. The ultimate treatment for IAH/ACS is to leave the abdominal fascia open after laparotomy, utilizing some form of temporary abdominal closure (TAC) techniques, resulting in an "open abdomen"(OA). The decision to accept an OA can only be made in the operating room and is typically made quite arbitrarily (there is no current standard or protocol),and the TAC used is based on the surgeon's best judgment. The study intends to randomize patients after it has been decided that a TAC is required, which will be applied in the operating room while the patient is fully anesthetized. The only intervention required is to obtain small aliquots (a teaspoonful-15ml) of blood for the evaluation of inflammatory mediators levels, as well as the same volume of intra-peritoneal fluid-that is typically discarded in patients with OA.

Detailed Description

Excessive pressure within the peritoneal cavity, known as intra-abdominal hypertension (IAH), can adversely affect not only intra-peritoneal organ function, but also other organ systems throughout the body. When IAH > 20 mmHg induces new organ dysfunction, a potentially lethal condition known as the abdominal compartment syndrome (ACS) is defined. Practically, this syndrome can be considered multi-system organ failure occurring from severe IAH. While the physical effects of IAH/ACS are increasingly being described, the humoral ones, related to IAH-induced ischemia are poorly understood. Recent animal work suggests that aggressively removing intra-peritoneal fluids, assumed to be vasoactive mediator-rich, leads to better systemic outcomes. There is no human data to support this however. Previous attempts at peritoneal drainage in inflammatory conditions such as sepsis and pancreatitis where not conclusive, but this may have been due to the inefficiency of the systems used and the lack of attention to IAH. Recently, efficient systems providing a temporary abdominal closure (TAC) to both drain intra-peritoneal fluids and to control IAH have been introduced. One of these dressing systems, known as the KCI AbThera™ Abdominal Dressing is currently approved for use in Canada as a temporary abdominal closure (TAC) device but its role in ameliorating systemic sepsis/SIRS has not been evaluated.

We propose a randomized trial of using either the "home Calgary Stampede Vac" involving wall suction or the KCI AbThera™ Abdominal Dressing, to dress the abdomen whenever the operative surgeon determines that an open abdomen is warranted to treat the patient.

In general, others have hypothesized that cytokines, especially peritoneal levels, are sensitive indicators of the post-operative inflammatory reaction and may predict complications. In experimental models IL-6 levels are higher in non-survivors. Further, previous work has noted that the blood level of IL-6, which has a longer half life than TNF-α or IL-1β, is a good index of the overall cytokine cascade activation. Thus the main outcomes to be compared will be between mean cytokine levels measured in each of the two treatment groups - to determine if the KCI AbThera™ Abdominal Dressing can significantly reduce the blood concentration of IL-6 when compared with the "Stampede VAC" system. We are hoping to better understand how the body responds to the inflammatory process that naturally occurs during and after an episode of intra-abdominal hypertension, to identify signals or markers of inflammation and infection as well as its progression and outcome.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Abdominal Compartment Syndrome
  • Intra-abdominal Hypertension
Intervention  ICMJE
  • Device: KCI AbThera

    The time that the dressing will be left in place will be left to the discretion of the attending surgeon, but revised practice guidelines mandate either formal abdominal closure or dressing change at 24-96 hours from placement. Upon the first OA dressing change, the surgeon is free to utilize whatever temporary closure they choose.

    Just prior to placement of the dressing, 16 ml (1 table spoon) of blood will be drawn from an existing arterial or venous line (this will qualify as Day 1). The same quantity of blood will be drawn on days 2, 3, 7 and 28 (or hospital discharge, whichever comes first). 15ml of peritoneal fluid will also be collected from the abdomen on the same days or until closure of the abdomen and removal of the dressing.

  • Device: "Stampede" VAC

    The time that the dressing will be left in place will be left to the discretion of the attending surgeon, but revised practice guidelines mandate either formal abdominal closure or dressing change at 24-96 hours from placement. Upon the first OA dressing change, the surgeon is free to utilize whatever temporary closure they choose.

    Just prior to placement of the dressing, 16 ml (1 table spoon) of blood will be drawn from an existing arterial or venous line (this will qualify as Day 1). The same quantity of blood will be drawn on days 2, 3, 7 and 28 (or hospital discharge, whichever comes first). 15ml of peritoneal fluid will also be collected from the abdomen on the same days or until closure of the abdomen and removal of the dressing.

Study Arms  ICMJE
  • Active Comparator: "Stampede" VAC
    Calgary-home-made "Stampede" VAC system with only closed drain bulb suction
    Intervention: Device: "Stampede" VAC
  • Experimental: KCI AbThera
    commercial AbThera vacuum assisted abdominal closure at 125 mmHg suction
    Intervention: Device: KCI AbThera
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: February 27, 2013)
50
Original Estimated Enrollment  ICMJE
 (submitted: May 16, 2011)
40
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Critically ill/injured requiring intensive care unit admission
  • Decision regarding the need to utilize an open abdomen technique after the first laparotomy
  • Age > 18
  • Non-pregnant

Exclusion Criteria:

  • Decision to formally close the abdomen after the initial laparotomy
  • Patients receiving intra-peritoneal chemotherapy
  • Pregnancy
  • Age < 18
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01355094
Other Study ID Numbers  ICMJE E-23706
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No plan
Responsible Party Andrew W Kirkpatrick, University of Calgary
Study Sponsor  ICMJE University of Calgary
Collaborators  ICMJE
  • KCI USA, Inc.
  • Alberta Health Services
Investigators  ICMJE
Principal Investigator: Andrew W Kirkpatrick, MD Canadian Trauma Trials Collaborative
PRS Account University of Calgary
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP