Browsing by Author "Doig, Christopher J"

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    Closed Or Open after Source Control Laparotomy for Severe Complicated Intra-Abdominal Sepsis (the COOL trial): study protocol for a randomized controlled trial
    (2018-06-22) Kirkpatrick, Andrew W; Coccolini, Federico; Ansaloni, Luca; Roberts, Derek J; Tolonen, Matti; McKee, Jessica L; Leppaniemi, Ari; Faris, Peter; Doig, Christopher J; Catena, Fausto; Fabian, Timothy; Jenne, Craig N; Chiara, Osvaldo; Kubes, Paul; Manns, Braden; Kluger, Yoram; Fraga, Gustavo P; Pereira, Bruno M; Diaz, Jose J; Sugrue, Michael; Moore, Ernest E; Ren, Jianan; Ball, Chad G; Coimbra, Raul; Balogh, Zsolt J; Abu-Zidan, Fikri M; Dixon, Elijah; Biffl, Walter; MacLean, Anthony; Ball, Ian; Drover, John; McBeth, Paul B; Posadas-Calleja, Juan G; Parry, Neil G; Di Saverio, Salomone; Ordonez, Carlos A; Xiao, Jimmy; Sartelli, Massimo
    Abstract Background Severe complicated intra-abdominal sepsis (SCIAS) has an increasing incidence with mortality rates over 80% in some settings. Mortality typically results from disruption of the gastrointestinal tract, progressive and self-perpetuating bio-mediator generation, systemic inflammation, and multiple organ failure. Principles of treatment include early antibiotic administration and operative source control. 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. 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. Methods 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. 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. The primary outcome will be 90-day survival. Secondary outcomes will be logistical, physiologic, safety, bio-mediators, microbiological, quality of life, and health-care costs. Secondary outcomes will include days free of ICU, ventilation, renal replacement therapy, and hospital at 30 days from the index laparotomy. Physiologic secondary outcomes will include changes in intensive care unit illness severity scores after laparotomy. 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. Economic outcomes will comprise standard costing for utilization of health-care resources. Discussion Although facial closure after SCIAS is considered the current standard of care, many reports are suggesting that OA management may improve outcomes in these patients. This trial will be powered to demonstrate a mortality difference in this highly lethal and morbid condition to ensure critically ill patients are receiving the best care possible and not being harmed by inappropriate therapies based on opinion only. Trial registration ClinicalTrials.gov , NCT03163095 .
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    Community paramedic point of care testing: validity and usability of two commercially available devices
    (2019-05-02) Blanchard, Ian E; Kozicky, Ryan; Dalgarno, Dana; Simms, Justin; Goulder, Stacy; Williamson, Tyler S; Biesbroek, Susan; Page, Lenore; Leaman, Karen; Snozyk, Suzanne; Redman, Lyle; Spackman, Keith; Doig, Christopher J; Lang, Eddy S; Lazarenko, Gerald
    Abstract Background Community Paramedics (CPs) require access to timely blood analysis in the field to guide treatment and transport decisions. Point of care testing (POCT), as opposed to laboratory analysis, may offer a solution, but limited research exists on CP POCT. The purpose of this study was to compare the validity of two devices (Abbott i-STAT® and Alere epoc®) by CPs in the community. Methods In a CP programme responding to 6000 annual patient care events, a split sample validation of POCT against traditional laboratory analysis for seven analytes (sodium, potassium, chloride, creatinine, hemoglobin, hematocrit, and glucose) was conducted on a consecutive sample of patients. The difference of proportion of discrepant results between POCT and laboratory was compared using a two sample proportion test. Usability was analysed by survey of CP experience, a linear mixed effects model of Systems Usability Scale (SUS) adjusted for CP clinical and POCT experience, an expert heuristic evaluation of devices, a review of device-logged errors, and coded observations of POCT use during quality control testing. Results Of 1649 episodes of care screened for enrollment, 174 required a blood draw, with 108 episodes (62.1%) enrolled from 73 participants. Participants had a mean age of 58.7 years (SD16.3); 49% were female. In 4 of 646 (0.6%) comparisons, POCT reported a critical value but the laboratory did not; with no statistically significant (p = 0.323) difference between i-STAT® (0.9%;95%CI:0.0,1.9%) compared with epoc® (0.3%;95%CI:0.0,0.9%). There were no instances of the laboratory reporting a critical value when POCT did not. In 88 of 1046 (8.4%) comparisons the a priori defined acceptable difference between POCT and the laboratory was exceeded; occurring more often in epoc® (10.7%;95%CI:8.1,13.3%) compared with i-STAT® (6.1%;95%CI:4.1,8.2%)(p = 0.007). Eighteen of 19 CP surveys were returned, with 11/18 (61.1%) preferring i-STAT® over epoc®. The i-STAT® had a higher mean SUS score (higher usability) compared with epoc® (84.0/100 vs. 59.6/100; p = 0.011). There were no statistically significant differences in device logged errors between i-STAT® and epoc® (p = 0.063). Conclusions CP programmes can expect clinically valid results from POCT. Device usability assessments should be considered with any local implementation as the two POCT systems have different strengths.
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    Correction to: Ethical considerations in conducting surgical research in severe complicated intra-abdominal sepsis
    (2019-10-17) Doig, Christopher J; Page, Stacey A; McKee, Jessica L; Moore, Ernest E; Abu-Zidan, Fikri M; Carroll, Rosemary; Marshall, John C; Faris, Peter D; Tolonen, Matti; Catena, Fausto; Coccolini, Federico; Sartelli, Massimo; Ansaloni, Luca; Minor, Sam F; Peirera, Bruno M; Diaz, Jose J; Kirkpatrick, Andrew W
    The original article [1] contained a typo in author, Federico Coccolini’s name. This has now been corrected.
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    Describing organ dysfunction in the intensive care unit: a cohort study of 20,000 patients
    (2019-05-23) Soo, Andrea; Zuege, Danny J; Fick, Gordon H; Niven, Daniel J; Berthiaume, Luc R; Stelfox, Henry T; Doig, Christopher J
    Abstract Background Multiple organ dysfunction is a common cause of morbidity and mortality in intensive care units (ICUs). Original development of the Sequential Organ Failure Assessment (SOFA) score was not to predict outcome, but to describe temporal changes in organ dysfunction in critically ill patients. Organ dysfunction scoring may be a reasonable surrogate outcome in clinical trials but further exploration of the impact of case mix on the temporal sequence of organ dysfunction is required. Our aim was to compare temporal changes in SOFA scores between hospital survivors and non-survivors. Methods We performed a population-based observational retrospective cohort study of critically ill patients admitted from January 1, 2004, to December 31, 2013, to 4 multisystem adult intensive care units (ICUs) in Calgary, Canada. The primary outcome was temporal changes in daily SOFA scores during the first 14 days of ICU admission. SOFA scores were modeled between hospital survivors and non-survivors using generalized estimating equations (GEE) and were also stratified by admission SOFA (≤ 11 versus > 11). Results The cohort consisted of 20,007 patients with at least one SOFA score and was mostly male (58.2%) with a median age of 59 (interquartile range [IQR] 44–72). Median ICU length of stay was 3.5 (IQR 1.7–7.5) days. ICU and hospital mortality were 18.5% and 25.5%, respectively. Temporal change in SOFA scores varied by survival and admission SOFA score in a complicated relationship. Area under the receiver operating characteristic (ROC) curve using admission SOFA as a predictor of hospital mortality was 0.77. The hospital mortality rate was 5.6% for patients with an admission SOFA of 0–2 and 94.4% with an admission SOFA of 20–24. There was an approximately linear increase in hospital mortality for SOFA scores of 3–19 (range 8.7–84.7%). Conclusions Examining the clinical course of organ dysfunction in a large non-selective cohort of patients provides insight into the utility of SOFA. We have demonstrated that hospital outcome is associated with both admission SOFA and the temporal rate of change in SOFA after admission. It is necessary to further explore the impact of additional clinical factors on the clinical course of SOFA with large datasets.
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    Efficacy and safety of active negative pressure peritoneal therapy for reducing the systemic inflammatory response after damage control laparotomy (the Intra- peritoneal Vacuum Trial): study protocol for a randomized controlled trial
    (BioMed Central, 2013-05-16) Roberts, Derek J; Jenne, Craig N; Ball, Chad G; Tiruta, Corina; Léger, Caroline; Xiao, Zhengwen; Faris, Peter D; McBeth, Paul B; Doig, Christopher J; Skinner, Christine R; Ruddell, Stacy G; Kubes, Paul; Kirkpatrick, Andrew W
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    Ethical considerations in conducting surgical research in severe complicated intra-abdominal sepsis
    (2019-08-05) Doig, Christopher J; Page, Stacey A; McKee, Jessica L; Moore, Ernest E; Abu-Zidan, Fikri M; Carroll, Rosemary; Marshall, John C; Faris, Peter D; Tolonen, Matti; Catena, Fausto; Cocolini, Federico; Sartelli, Massimo; Ansaloni, Luca; Minor, Sam F; Peirera, Bruno M; Diaz, Jose J; Kirkpatrick, Andrew W
    Abstract Background Severe complicated intra-abdominal sepsis (SCIAS) has high mortality, thought due in part to progressive bio-mediator generation, systemic inflammation, and multiple organ failure. Treatment includes early antibiotics and operative source control. At surgery, open abdomen management with negative-peritoneal-pressure therapy (NPPT) has been hypothesized to mitigate MOF and death, although clinical equipoise for this operative approach exists. The Closed or Open after Laparotomy (COOL) study ( https://clinicaltrials.gov/ct2/show/NCT03163095 ) will prospectively randomize eligible patients intra-operatively to formal abdominal closure or OA with NPTT. We review the ethical basis for conducting research in SCIAS. Main body Research in critically ill incapacitated patients is important to advance care. Conducting research among SCIAS is complicated due to the severity of illness including delirium, need for emergent interventions, diagnostic criteria confirmed only at laparotomy, and obtundation from anaesthesia. In other circumstances involving critically ill patients, clinical experts have worked closely with ethicists to apply principles that balance the rights of patients whilst simultaneously permitting inclusion in research. In Canada, the Tri-Council Policy Statement-2 (TCPS-2) describes six criteria that permit study enrollment and randomization in such situations: (a) serious threat to the prospective participant requires immediate intervention; (b) either no standard efficacious care exists or the research offers realistic possibility of direct benefit; (c) risks are not greater than that involved in standard care or are clearly justified by prospect for direct benefits; (d) prospective participant is unconscious or lacks capacity to understand the complexities of the research; (e) third-party authorization cannot be secured in sufficient time; and (f) no relevant prior directives are known to exist that preclude participation. TCPS-2 criteria are in principle not dissimilar to other (inter)national criteria. The COOL study will use waiver of consent to initiate enrollment and randomization, followed by surrogate or proxy consent, and finally delayed informed consent in subjects that survive and regain capacity. Conclusions A delayed consent mechanism is a practical and ethical solution to challenges in research in SCIAS. The ultimate goal of consent is to balance respect for patient participants and to permit participation in new trials with a reasonable opportunity for improved outcome and minimal risk of harm.
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    Getting the invite list right: a discussion of sepsis severity scoring systems in severe complicated intra-abdominal sepsis and randomized trial inclusion criteria
    (2018-04-06) Tolonen, Matti; Coccolini, Federico; Ansaloni, Luca; Sartelli, Massimo; Roberts, Derek J; McKee, Jessica L; Leppaniemi, Ari; Doig, Christopher J; Catena, Fausto; Fabian, Timothy; Jenne, Craig N; Chiara, Osvaldo; Kubes, Paul; Kluger, Yoram; Fraga, Gustavo P; Pereira, Bruno M; Diaz, Jose J; Sugrue, Michael; Moore, Ernest E; Ren, Jianan; Ball, Chad G; Coimbra, Raul; Dixon, Elijah; Biffl, Walter; MacLean, Anthony; McBeth, Paul B; Posadas-Calleja, Juan G; Di Saverio, Salomone; Xiao, Jimmy; Kirkpatrick, Andrew W
    Abstract Background Severe complicated intra-abdominal sepsis (SCIAS) is a worldwide challenge with increasing incidence. Open abdomen management with enhanced clearance of fluid and biomediators from the peritoneum is a potential therapy requiring prospective evaluation. Given the complexity of powering multi-center trials, it is essential to recruit an inception cohort sick enough to benefit from the intervention; otherwise, no effect of a potentially beneficial therapy may be apparent. An evaluation of abilities of recognized predictive systems to recognize SCIAS patients was conducted using an existing intra-abdominal sepsis (IAS) database. Methods All consecutive adult patients with a diffuse secondary peritonitis between 2012 and 2013 were collected from a quaternary care hospital in Finland, excluding appendicitis/cholecystitis. From this retrospectively collected database, a target population (93) of those with either ICU admission or mortality were selected. The performance metrics of the Third Consensus Definitions for Sepsis and Septic Shock based on both SOFA and quick SOFA, the World Society of Emergency Surgery Sepsis Severity Score (WSESSSS), the APACHE II score, Manheim Peritonitis Index (MPI), and the Calgary Predisposition, Infection, Response, and Organ dysfunction (CPIRO) score were all tested for their discriminant ability to identify this subgroup with SCIAS and to predict mortality. Results Predictive systems with an area under-the-receiving-operating characteristic (AUC) curve > 0.8 included SOFA, Sepsis-3 definitions, APACHE II, WSESSSS, and CPIRO scores with the overall best for CPIRO. The highest identification rates were SOFA score ≥ 2 (78.4%), followed by the WSESSSS score ≥ 8 (73.1%), SOFA ≥ 3 (75.2%), and APACHE II ≥ 14 (68.8%) identification. Combining the Sepsis-3 septic-shock definition and WSESSS ≥ 8 increased detection to 80%. Including CPIRO score ≥ 3 increased this to 82.8% (Sensitivity-SN; 83% Specificity-SP; 74%. Comparatively, SOFA ≥ 4 and WSESSSS ≥ 8 with or without septic-shock had 83.9% detection (SN; 84%, SP; 75%, 25% mortality). Conclusions No one scoring system behaves perfectly, and all are largely dominated by organ dysfunction. Utilizing combinations of SOFA, CPIRO, and WSESSSS scores in addition to the Sepsis-3 septic shock definition appears to offer the widest “inclusion-criteria” to recognize patients with a high chance of mortality and ICU admission. Trial registration https://clinicaltrials.gov/ct2/show/NCT03163095 ; Registered on May 22, 2017.
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    Outcomes of selective nonoperative management of civilian abdominal gunshot wounds: a systematic review and meta-analysis
    (2018-11-27) Al Rawahi, Aziza N; Al Hinai, Fatma A; Boyd, Jamie M; Doig, Christopher J; Ball, Chad G; Velmahos, George C; Kirkpatrick, Andrew W; Navsaria, Pradeep H; Roberts, Derek J
    Abstract Background Although mandatory laparotomy has been standard of care for patients with abdominal gunshot wounds (GSWs) for decades, this approach is associated with non-therapeutic operations, morbidity, and long hospital stays. This systematic review and meta-analysis sought to summarize outcomes of selective nonoperative management (SNOM) of civilian abdominal GSWs. Methods We searched electronic databases (March 1966–April 1, 2017) and reference lists of articles included in the systematic review for studies reporting outcomes of SNOM of civilian abdominal GSWs. We meta-analyzed the associated risks of SNOM-related failure (defined as laparotomy during hospital admission), mortality, and morbidity across included studies using DerSimonian and Laird random-effects models. Between-study heterogeneity was assessed by calculating I2 statistics and conducting tests of homogeneity. Results Of 7155 citations identified, we included 41 studies [n = 22,847 patients with abdominal GSWs, of whom 6777 (29.7%) underwent SNOM]. The pooled risk of failure of SNOM in hemodynamically stable patients without a reduced level of consciousness or signs of peritonitis was 7.0% [95% confidence interval (CI) = 3.9–10.1%; I2 = 92.6%, homogeneity p < 0.001] while the pooled mortality associated with use of SNOM in this patient population was 0.4% (95% CI = 0.2–0.6%; I2 = 0%, homogeneity p > 0.99). In patients who failed SNOM, the pooled estimate of the risk of therapeutic laparotomy was 68.0% (95% CI = 58.3–77.7%; I2 = 91.5%; homogeneity p < 0.001). Risks of failure of SNOM were lowest in studies that evaluated patients with right thoracoabdomen (3.4%; 95% CI = 0–7.0%; I2 = 0%; homogeneity p = 0.45), flank (7.0%; 95% CI = 3.9–10.1%), and back (3.1%; 95% CI = 0–6.5%) GSWs and highest in those that evaluated patients with anterior abdomen (13.2%; 95% CI = 6.3–20.1%) GSWs. In patients who underwent mandatory abdominopelvic computed tomography (CT), the pooled risk of failure was 4.1% versus 8.3% in those who underwent selective CT (p = 0.08). The overall sample-size-weighted mean hospital length of stay among patients who underwent SNOM was 6 days versus 10 days if they failed SNOM or developed an in-hospital complication. Conclusions SNOM of abdominal GSWs is safe when conducted in hemodynamically stable patients without a reduced level of consciousness or signs of peritonitis. Failure of SNOM may be lower in patients with GSWs to the back, flank, or right thoracoabdomen and be decreased by mandatory use of abdominopelvic CT scans.
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    The prognostic value of serum procalcitonin measurements in critically injured patients: a systematic review
    (2019-12-03) AlRawahi, Aziza N; AlHinai, Fatma A; Doig, Christopher J; Ball, Chad G; Dixon, Elijah; Xiao, Zhengwen; Kirkpatrick, Andrew W
    Abstract Background Major trauma is associated with high incidence of septic complications and multiple organ dysfunction (MOD), which markedly influence the outcome of injured patients. Early identification of patients at risk of developing posttraumatic complications is crucial to provide early treatment and improve outcomes. We sought to evaluate the prognostic value of serum procalcitonin (PCT) levels after trauma as related to severity of injury, sepsis, organ dysfunction, and mortality. Methods We searched PubMed, MEDLINE, EMBASE, the Cochrane Database, and references of included articles. Two investigators independently identified eligible studies and extracted data. We included original studies that assessed the prognostic value of serum PCT levels in predicting severity of injury, sepsis, organ dysfunction, and mortality among critically injured adult patients. Results Among 2015 citations, 19 studies (17 prospective; 2 retrospective) met inclusion criteria. Methodological quality of included studies was moderate. All studies showed a strong correlation between initial PCT levels and Injury Severity Score (ISS). Twelve out of 16 studies demonstrated significant elevation of initial PCT levels in patients who later developed sepsis after trauma. PCT level appeared a strong predictor of MOD in seven out of nine studies. While two studies did not show association between PCT levels and mortality, four studies demonstrated significant elevation of PCT levels in non-survivors versus survivors. One study reported that the PCT level of ≥ 5 ng/mL was associated with significantly increased mortality (OR 3.65; 95% CI 1.03–12.9; p = 0.04). Conclusion PCT appears promising as a surrogate biomarker for trauma. Initial peak PCT level may be used as an early predictor of sepsis, MOD, and mortality in trauma population.
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    A validation of ground ambulance pre-hospital times modeled using geographic information systems
    (BioMed Central, 2012-10-03) Patel, Alka B; Waters, Nigel M; Blanchard, Ian E; Doig, Christopher J; Ghali, William A