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Sepsis and Abdominal Drainage (SAD)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
KCI USA, Inc.
AHS Cancer Control Alberta
Information provided by (Responsible Party):
Andrew W Kirkpatrick, University of Calgary
ClinicalTrials.gov Identifier:
NCT01355094
First received: May 12, 2011
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Abdominal Compartment Syndrome
Intra-abdominal Hypertension
Device: KCI AbThera
Device: "Stampede" VAC
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • Systemic inflammatory marker levels and peritoneal fluid inflammatory marker levels [ Time Frame: admission to dicharge, expected average of hospital stay 4 weeks. ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Physiological Outcomes [ Time Frame: admission to hospital discharge; expected average of hospital stay 4 weeks. ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 50
Study Start Date: June 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: "Stampede" VAC
Calgary-home-made "Stampede" VAC system with only closed drain bulb suction
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.

Experimental: KCI AbThera
commercial AbThera vacuum assisted abdominal closure at 125 mmHg suction
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.


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01355094

Locations
Canada, Alberta
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
Sponsors and Collaborators
University of Calgary
KCI USA, Inc.
AHS Cancer Control Alberta
Investigators
Principal Investigator: Andrew W Kirkpatrick, MD Canadian Trauma Trials Collaborative
  More Information

Publications:
Dellinger RP, Levy MM, Carlet JM, Bion J, Parker MM, Jaeschke R, Reinhart K, Angus DC, Brun-Buisson C, Beale R, Calandra T, Dhainaut JF, Gerlach H, Harvey M, Marini JJ, Marshall J, Ranieri M, Ramsay G, Sevransky J, Thompson BT, Townsend S, Vender JS, Zimmerman JL, Vincent JL; International Surviving Sepsis Campaign Guidelines Committee; American Association of Critical-Care Nurses; American College of Chest Physicians; American College of Emergency Physicians; Canadian Critical Care Society; European Society of Clinical Microbiology and Infectious Diseases; European Society of Intensive Care Medicine; European Respiratory Society; International Sepsis Forum; Japanese Association for Acute Medicine; Japanese Society of Intensive Care Medicine; Society of Critical Care Medicine; Society of Hospital Medicine; Surgical Infection Society; World Federation of Societies of Intensive and Critical Care Medicine. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock: 2008. Crit Care Med. 2008 Jan;36(1):296-327. Erratum in: Crit Care Med. 2008 Apr;36(4):1394-6.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Andrew W Kirkpatrick, Medical Director, Trauma Services, CD, MD, FACS, FRCSC, MHSc, University of Calgary
ClinicalTrials.gov Identifier: NCT01355094     History of Changes
Other Study ID Numbers: E-23706
Study First Received: May 12, 2011
Last Updated: July 2, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of Calgary:
temporary abdomen closure
peritoneal vacuum therapy
open abdomen
abdominal compartment syndrome
intra-abdominal sepsis
intra-abdominal hypertension
critical care

Additional relevant MeSH terms:
Compartment Syndromes
Hypertension
Intra-Abdominal Hypertension
Syndrome
Cardiovascular Diseases
Disease
Muscular Diseases
Musculoskeletal Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 24, 2014