Economic outcomes will comprise standard costing for utilization of health-care resources.
Bio-mediator outcomes for participating centers will involve measurement of interleukin (IL)-6 and IL-10, procalcitonin, activated protein C (APC), high-mobility group box protein-1, complement factors, and mitochondrial DNA. Physiologic secondary outcomes will include changes in intensive care unit illness severity scores after laparotomy.
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Secondary outcomes will include days free of ICU, ventilation, renal replacement therapy, and hospital at 30 days from the index laparotomy. Secondary outcomes will be logistical, physiologic, safety, bio-mediators, microbiological, quality of life, and health-care costs. The primary outcome will be 90-day survival. Patients will be eligible if they have free uncontained intra-peritoneal contamination and physiologic derangements exemplified by septic shock OR a Predisposition-Infection-Response-Organ Dysfunction Score ≥ 3 or a World-Society-of-Emergency-Surgery-Sepsis-Severity-Score ≥ 8.
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The Closed Or Open after Laparotomy (COOL) study will constitute a prospective randomized controlled trial that will randomly allocate eligible surgical patients intra-operatively to either formal closure of the fascia or use of the OA with application of an ANPTT dressing. Although there is now a biologic rationale for such an intervention as well as non-standardized and erratic clinical utilization, this remains a novel therapy with potential side effects and clinical equipoise. A further therapeutic option may be open abdomen (OA) management with active negative peritoneal pressure therapy (ANPPT) to remove inflammatory ascites and ameliorate the systemic damage from SCIAS. Principles of treatment include early antibiotic administration and operative source control. Mortality typically results from disruption of the gastrointestinal tract, progressive and self-perpetuating bio-mediator generation, systemic inflammation, and multiple organ failure. Severe complicated intra-abdominal sepsis (SCIAS) has an increasing incidence with mortality rates over 80% in some settings. World Journal of Emergency Surgery volume 13, Article number: 26 ( 2018) for The Closed Or Open after Laparotomy (COOL) after Source Control for Severe Complicated Intra-Abdominal Sepsis Investigators.Wrote the paper: MGH PK.Closed Or Open after Source Control Laparotomy for Severe Complicated Intra-Abdominal Sepsis (the COOL trial): study protocol for a randomized controlled trial Contributed reagents/materials/analysis tools: KZ JC PK. Author ContributionsĬonceived and designed the experiments: MGH KZ JC PK. The authors have declared that no competing interests exist. * E-mail: Calvin, Phoebe, and Joan Snyder Institute for Chronic Diseases, University of Calgary, Calgary, Alberta, Canada,ĭepartment of Physiology and Pharmacology, University of Calgary, Calgary, Alberta, Canada,ĭepartment of Critical Care, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada The Calvin, Phoebe, and Joan Snyder Institute for Chronic Diseases, University of Calgary, Calgary, Alberta, Canada,ĭepartment of Microbiology, Immunology and Infectious Diseases, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada,ĭepartment of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada,ĭepartment of Pathology and Laboratory Medicine, University of Calgary, Calgary, Alberta, Canada The Calvin, Phoebe, and Joan Snyder Institute for Chronic Diseases, University of Calgary, Calgary, Alberta, Canada
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