The epidemiology of sepsis in general surgery patients.

BACKGROUND: Sepsis is increasing in hospitalized patients. Our purpose is to describe its current epidemiology in a general surgery (GS) intensive care unit (ICU) where patients are routinely screened and aggressively treated for sepsis by an established protocol. METHODS: Our prospective, Institutional Review Board-approved sepsis research database was queried for demographics, biomarkers reflecting organ dysfunction, and mortality. Patients were grouped as sepsis, severe sepsis, or septic shock using refined consensus criteria. Data are compared by analysis of variance, Student's t test, and χ test (p<0.05 significant). RESULTS: During 24 months ending September 2009, 231 patients (aged 59 years ± 3 years; 43% men) were treated for sepsis. The abdomen was the source of infection in 69% of patients. Several baseline biomarkers of organ dysfunction (BOD) correlated with sepsis severity including lactate, creatinine, international normalized ratio, platelet count, and d-dimer. Direct correlation with mortality was noted with particular baseline BODs including beta natriuretic peptide, international normalized ratio, platelet count, aspartate transaminase, alanine aminotransferase, and total bilirubin. Most patients present with severe sepsis (56%) or septic shock (26%) each with increasing multiple BODs. Septic shock has prohibitive mortality rate (36%), and those who survive septic shock have prolonged ICU stays. CONCLUSION: In general surgery ICU patients, sepsis is predominantly caused by intra-abdominal infection. Multiple BODs are present in severe sepsis and septic shock but are notably advanced in septic shock. Despite aggressive sepsis screening and treatment, septic shock remains a morbid condition.

Computer protocol facilitates evidence-based care of sepsis in the surgical intensive care unit.

BACKGROUND: Care of sepsis has been the focus of intense research and guideline development for more than two decades. With ongoing success of computer protocol (CP) technology and with publication of Surviving Sepsis Campaign (SSC) guidelines, we undertook protocol development for management of sepsis of surgical intensive care unit patients in mid-2006. METHODS: A sepsis protocol was developed and implemented in The Methodist Hospital (TMH) (Houston, TX) surgical intensive care unit (27 beds) together with a sepsis research database. We compare paper-protocol (PP) (2008) and CP (2009) performance and results of the SSC guideline performance improvement initiative (2005-2008). TMH surgical intensive care unit sepsis protocol was developed to implement best evidence and to standardize decision making among surgical intensivists, nurse practitioners, and resident physicians. RESULTS: The 2008 and 2009 sepsis protocol cohorts had very similar number of patients, age, % male gender, Acute Physiology and Chronic Health Evaluation scoring system II, and Sequential Organ Failure Assessment scores. The 2008 PP patients had greater baseline lactate concentration consistent with greater mortality rate. Antibiotic agents were administered to 2009 CP cohort patients sooner than 2008 PP cohort patients. Both cohorts received similar volume of intravenous fluid boluses. Comparing 6-hour resuscitation bundle compliance, the 2009 CP cohort was substantially greater than SSC eighth quarter and 2008 PP cohorts (79% vs. 31% vs. 29%), and mortality rate was much less when using the CP (14% vs. 31% vs. 24%). CONCLUSIONS: Our comprehensive sepsis protocol has enabled rapid and consistent implementation of evidence-based care, and, implemented as a bedside CP, contributed to decreased mortality rate for management of surgical sepsis.

Performance of a computerized protocol for trauma shock resuscitation.

BACKGROUND: A computerized protocol was developed and used to standardize bedside clinician decision making for resuscitation of shock due to severe trauma during the first day in the intensive care unit (ICU) at a metropolitan Level I trauma center. We report overall performance of a computerized protocol for resuscitation of shock due to severe trauma, incorporating two options for resuscitation monitoring and intervention intensity, according to: (1) duration of use and (2) acceptance of computerized protocol-generated instructions. METHODS: A computerized protocol operated by clinicians, using a personal computer (PC) at the bedside, was used to guide clinical decision making for resuscitation of patients meeting specific injury and shock criteria. The protocol generated instructions that could be accepted or declined. Clinician acceptance of the protocol instructions was stored by the PC software in a database for each patient. A rule-based, data-driven protocol was developed using literature evidence, expert opinion, and ongoing protocol performance analysis. Logic-flow diagrams were used to facilitate communication among multidisciplinary protocol development team members. The protocol was computerized using standard programming methods and implemented using cart-mounted PCs with a touch screen and keyboard interfaces. Protocol progression began with patient demographic data and criteria entry, confirmation of hemodynamic monitor instrumentation, request for specific hemodynamic performance data, and instructions for specific interventions (or no intervention). Use and performance of the computerized protocol was recorded in a protocol execution database. The protocol was continuously maintained with new literature evidence and database performance analysis findings. Initially implemented in 2000, the computerized protocol was refined in 2004 with two options for resuscitation intensity: pulmonary artery catheter- and central venous pressure-directed resuscitation. RESULTS: Over 2 years ending at August 2006, a total of 193 trauma patients (mean Injury Severity Score was 27, survival rate 89%) were resuscitated using the computerized protocol. Protocol duration was 4400 hours or 22.7 +/- 0.4 hours per patient. The computerized protocol generated 3724 instructions (19 +/- 1 per patient) that required a bedside clinician response. In all, 94% of these instructions were accepted by the bedside clinician users. CONCLUSIONS: A computerized protocol to guide decision making for trauma shock resuscitation in a Level 1 trauma center surgical ICU was developed and used as standard of care. During 2 years ending at August 2006, 94% of computer-generated instructions for specific interventions or measurements of hemodynamic performance were accepted by bedside clinicians, indicating appropriate, useful design and reliance on the computerized protocol system.

Enteral glutamine during active shock resuscitation is safe and enhances tolerance of enteral feeding.

BACKGROUND: Feeding the hemodynamically unstable patient is increasingly practiced, yet few data exist on its safety. Because enteral glutamine is protective to the gut in experimental models of shock and improves clinical outcomes, it may benefit trauma patients undergoing shock resuscitation and improve tolerance if administered early. This pilot study aimed to evaluate gastrointestinal tolerance and safety of enteral feeding with glutamine, beginning during shock resuscitation in severely injured patients. METHODS: In a prospective randomized trial, 20 patients were randomly assigned to either an enteral glutamine group (n = 10) or a control group (n = 10). Patients with severe trauma meeting standardized shock resuscitation criteria received enteral glutamine 0.5 g/kg/d during the first 24 hours of resuscitation and 10 days thereafter. Immune-enhancing diet began on postinjury day 1, with a target of 25 kcal/kg/d. Control patients received isonitrogenous whey powder plus immune-enhancing diet. Tolerance (vomiting, nasogastric output, diarrhea, and distention) was assessed throughout the study. RESULTS: Glutamine was well tolerated and no adverse events occurred. Treated patients had significantly fewer instances of high nasogastric output (5 vs 23; p = .010), abdominal distention (3 vs 12; p = .021), and total instances of intolerance (8 vs 42; p = .011). Intensive care unit (ICU) and hospital length of stay were comparable. Control patients required supplemental parenteral nutrition (PN) to meet goals at day 7. CONCLUSIONS: Enteral glutamine administered during active shock resuscitation and through the early postinjury period is safe and enhances gastrointestinal tolerance. A large clinical trial is warranted to determine if enteral glutamine administered to the hemodynamically unstable patient can reduce infectious morbidity and mortality.

Computerized clinical decision support: a technology to implement and validate evidence based guidelines.

UNLABELLED: Faced with a documented crisis of patients not receiving appropriate care, there is a need to implement and refine evidence-based guidelines (EBGs) to ensure that patients receive the best care available. Although valuable in content, among their deficiencies, EBGs do not provide explicit methods to bring proven therapies to the bedside. Computerized information technology, now an integral part of the US healthcare system at all levels, presents clinicians with information from laboratory, imaging, physiologic monitoring systems, and many other sources. It is imperative that we clinicians use this information technology to improve medical care and efficacy of its delivery. If we do not do this, nonclinicians will use this technology to tell us how to practice medicine. Computerized clinical decision support (CCDS) offers a powerful method to use this information and implement a broad range of EBGs. CCDS is a technology that can be used to develop, implement, and refine computerized protocols for specific processes of care derived from EBGs, including complex care provided in intensive care units. We describe this technology as a desirable option for the trauma community to use information technology and maintain the trauma surgeon/intensivist's essential role in specifying and implementing best care for patients. We describe a process of logical protocol development based on standardized clinical decision making to enable EBGs. The resulting logical process is readily computerized, and, when properly implemented, provides a stable platform for systematic review and study of the process and interventions. CONCLUSION: : CCDS to implement and refine EBG derived computerized protocols offers a method to decrease variability, test interventions, and validate improved quality of care.

Preload optimization using "starling curve" generation during shock resuscitation: can it be done?

Preload-directed resuscitation is the standard of care in U.S. trauma centers. As part of our standardized protocol for traumatic shock resuscitation, patients who do not respond to initial interventions of hemoglobin replacement and fluid volume loading have optimal preload determined using a standardized algorithm to generate a "Starling curve." We retrospectively analyzed data from 147 consecutive resuscitation protocol patients during the 24 months ending August 2002. Fifty (34%) of these patients required preload optimization, of which the optimization algorithm was completed in 36 (72%). The average age of those who required preload optimization was 44 +/- 3 years vs. 34 +/- 1 years for patients who did not. Execution of the algorithm caused PCWP to increase from 18 +/- 1 mmHg to a maximum of 25 +/- 2 mmHg and CI to increase from 3.2 +/- 0.1 L/min m(-2) to 4.5 +/- 0.4 L/min m(-2). Algorithm logic determined PCWP = 24 +/- 2 to be optimal preload at the maximum CI = 4.8 +/- 0.4, and as the volume loading threshold for the remaining time of the resuscitation process. Starling curve preload optimization was begun 6.5 +/- 0.8 h after start of the resuscitation protocol and required 36 +/- 5 min and 4 +/- 0.4 fluid boluses (1.6 +/- 0.2 L). Comparison of early response of those patients who required preload optimization and those who did not indicated hemodynamic compromise apparent in the 1st 4 h of standardized resuscitation. We conclude that preload optimization using sequential fluid bolus and PCWP-CI measurement to generate a Starling curve is feasible during ICU shock resuscitation, but that there is the disadvantage that increasing and maintaining high PCWP may contribute to problematic tissue edema.

Standardized trauma resuscitation: female hearts respond better.

HYPOTHESIS: Women respond better to standardized shock resuscitation compared with similarly severely injured men. DESIGN: Severely injured patients who met specific criteria were resuscitated using a standardized protocol with no adjustment for gender. The resuscitation protocol was used to attain and to maintain an oxygen delivery index of 600 mL/min. m(2) or greater (DO(2)I > or = 600) for the first 24 hours in the intensive care unit (ICU). Interventions, responses, and outcomes for the 2 cohorts were compared. Data were analyzed using analysis of variance, chi(2), and t tests; P<.05 was considered significant. SETTING: A 20-bed regional level I trauma center ICU. PATIENTS: Patients at high risk of postinjury multiple organ failure (major organ or vascular injury and/or skeletal fractures, initial arterial base deficit of 6 mEq/L or greater, requirement for 6 units or more of packed red blood cells in the first 12 hours after hospital admission, or age > or = 65 years with any 2 previous criteria). INTERVENTIONS: Pulmonary artery catheter, packed red blood cell transfusion, crystalloid fluid infusion, inotrope, and vasopressor support, as needed, in that sequence, to maintain DO(2)I > or = 600. MAIN OUTCOME MEASURES: Hemodynamic response to resuscitation, fluid, and packed red blood cell volume. RESULTS: During 2000, 58 patients (38 men, 20 women) met criteria and were resuscitated using our standardized protocol. Demographics and outcomes were similar for both cohorts. Requirements for and responses to standardized resuscitation were also similar, except for volume loading. The female cohort required less lactated Ringer solution volume (12 +/- 1 vs 8 +/- 2 L, P<.05), required less Starling curve intervention (42% vs 15%, P<.05), and maintained the DO(2)I goal with average pulmonary capillary wedge pressure that was less than that of the male cohort. CONCLUSION: Review of prospective data from standardized shock resuscitation for female and male cohorts demonstrates that women respond better to standardized resuscitation compared with similarly severely injured men.

Supranormal trauma resuscitation causes more cases of abdominal compartment syndrome.

HYPOTHESIS: Normal resuscitation (oxygen delivery index [DO2I] >/=500 mL/min per square meter), compared with supranormal trauma resuscitation (DO2I >/=600 mL/min per square meter), requires less crystalloid volume, thus decreasing the incidence of intra-abdominal hypertension (IAH) and abdominal compartment syndrome (ACS). DESIGN: Retrospective analysis of a prospective database. SETTING: Twenty-bed intensive care unit (ICU) in a regional level I trauma center. PATIENTS: Patients with major trauma (injury severity score >15, initial base deficit >/=6 mEq/L, or need for >/=6 units of packed red blood cells in the first 12 hours) or age 65 years or older with any 2 of the previous criteria. INTERVENTIONS: Shock/trauma resuscitation protocol: pulmonary artery catheter, gastric tonometry, urinary bladder pressure measurements, lactated Ringer infusion, packed red blood cell transfusion, and moderate inotrope support, as needed, in that sequence, to attain and maintain a DO2I greater than or equal to 600 mL/min per m2 (16 months, ending January 1, 2001, n = 85) or a DO2I greater than or equal to 500 mL/min per square meter (16 months, starting January 1, 2001, n = 71) for the first 24 hours in the ICU. MAIN OUTCOME MEASURES: Lactated Ringer infusion volume (liters) at ICU admission, gastric partial carbon dioxide minus end-tidal carbon dioxide(GAPCO2), IAH (urinary bladder pressure measurements >20 mm Hg), ACS (urinary bladder pressure measurements >25 mm Hg with organ dysfunction), multiple organ failure, and mortality. RESULTS: Demographics, injury severity, and shock severity parameters were similar in both groups. The supranormal resuscitation group required more lactated Ringer infusion volume in the first 24 hours in the ICU (mean +/- SD, 13 +/- 2 vs 7 +/- 1 L; P<.05) and had higher GAPCO2 (16 +/- 2 vs 7 +/- 1 mm Hg; P<.05). In the supranormal group, IAH (42% vs 20%; P<.05) and ACS (16% vs 8%; P<.05) were more frequent. The conventional trauma outcomes, such as multiple organ failure (22% vs 9%; P<.05) and mortality (27% vs 11%; P<.05) were less favorable in the supranormal resuscitation group. CONCLUSION: Supranormal resuscitation, compared with normal resuscitation, was associated with more lactated Ringer infusion, decreased intestinal perfusion (higher GAPCO2), and an increased incidence of IAH, ACS, multiple organ failure, and death.

Convergence on a standard for representing clinical guidelines: work in health level seven.

Concern regarding patient safety and practice variation has focused attention on clinical guidelines as a way of influencing the behavior of health care providers in order to improve patient outcomes. Despite the abundant number of guidelines produced, their use has been limited, in part because the necessary knowledge is relatively inaccessible at the point of care. In turn, this has led researchers to make guidelines computable so that they can be employed in information systems that provide tailored decision support. A number of different efforts have been mounted to create a standard formalism. Health Level Seven (HL7) is a key international standards development organization. Ongoing work in HL7 attempts to synthesize the best aspects of these efforts, producing along the way shareable components of a guideline representation, such as a common expression language and standard data model. These shareable components require in turn an information architecture that makes available a range of patient data encoded in an appropriate format. Convergence on a standard guideline formalism will facilitate use of guidelines and thus enhance patient care.

Computer versus paper system for recognition and management of sepsis in surgical intensive care.

BACKGROUND: A system to provide surveillance, diagnosis, and protocolized management of surgical intensive care unit (SICU) sepsis was undertaken as a performance improvement project. A system for sepsis management was implemented for SICU patients using paper followed by a computerized system. The hypothesis was that the computerized system would be associated with improved process and outcomes. METHODS: A system was designed to provide early recognition and guide patient-specific management of sepsis including (1) modified early warning signs-sepsis recognition score (MEWS-SRS; summative point score of ranges of vital signs, mental status, white blood cell count; after every 4 hours) by bedside nurse; (2) suspected site assessment (vascular access, lung, abdomen, urinary tract, soft tissue, other) at bedside by physician or extender; (3) sepsis management protocol (replicable, point-of-care decisions) at bedside by nurse, physician, and extender. The system was implemented first using paper and then a computerized system. Sepsis severity was defined using standard criteria. RESULTS: In January to May 2012, a paper system was used to manage 77 consecutive sepsis encounters (3.9 ± 0.5 cases per week) in 65 patients (77% male; age, 53 ± 2 years). In June to December 2012, a computerized system was used to manage 132 consecutive sepsis encounters (4.4 ± 0.4 cases per week) in 119 patients (63% male; age, 58 ± 2 years). MEWS-SRS elicited 683 site assessments, and 201 had sepsis diagnosis and protocol management. The predominant site of infection was abdomen (paper, 58%; computer, 53%). Recognition of early sepsis tended to occur more using the computerized system (paper, 23%; computer, 35%). Hospital mortality rate for surgical ICU sepsis (paper, 20%; computer, 14%) was less with the computerized system. CONCLUSION: A computerized sepsis management system improves care process and outcome. Early sepsis is recognized and managed with greater frequency compared with severe sepsis or septic shock. The system has a beneficial effect as a clinical standard of care for SICU patients. LEVEL OF EVIDENCE: Therapeutic study, level III.

Identification of cardiac dysfunction in sepsis with B-type natriuretic peptide.

BACKGROUND: B-type natriuretic peptide (BNP) is secreted in response to myocardial stretch and has been used clinically to assess volume overload and predict death in congestive heart failure. More recently, BNP elevation has been demonstrated with septic shock and is predictive of death. How BNP levels relate to cardiac function in sepsis remains to be established. STUDY DESIGN: Retrospective review of prospectively gathered sepsis database from a surgical ICU in a tertiary academic hospital. Initial BNP levels, patient demographics, baseline central venous pressure levels, and in-hospital mortality were obtained. Transthoracic echocardiography was performed during initial resuscitation per protocol. RESULTS: During 24 months ending in September 2009, two hundred and thirty-one patients (59 ± 3 years of age, 43% male) were treated for sepsis. Baseline BNP increased with initial sepsis severity (ie, sepsis vs severe sepsis vs septic shock, by ANOVA; p < 0.05) and was higher in those who died vs those who lived (by Fisher's exact test; p < 0.05). Of these patients, 153 (66%) had early echocardiography. Low ejection fraction (<50%) was associated with higher BNP (by Fisher's exact test; p < 0.05) and patients with low ejection fraction had a higher mortality (39% vs 20%; odds ratio = 3.03). We found no correlation between baseline central venous pressure (12.7 ± 6.10 mmHg) and BNP (526.5 ± 82.10 pg/mL) (by Spearman's ρ, R(s) = .001) for the entire sepsis population. CONCLUSIONS: In surgical sepsis patients, BNP increases with sepsis severity and is associated with early systolic dysfunction, which in turn is associated with death. Monitoring BNP in early sepsis to identify occult systolic dysfunction might prompt earlier use of inotropic agents.

Central venous pressure versus pulmonary artery catheter-directed shock resuscitation.

Previously, we developed a protocol for shock resuscitation of severe trauma patients to reverse shock and regain hemodynamic stability during the first 24 intensive care unit (ICU) hours. Key hemodynamic measurements of cardiac output and preload were obtained using a pulmonary artery catheter (PAC). As an alternative, we developed a protocol that used central venous pressure (CVP) to guide decision making for interventions to regain hemodynamic stability [mean arterial pressure (MAP) >or= 65 mmHg and heart rate (HR) or= 6 mEq/L or systolic blood pressure < 90 mmHg, 3) transfusion of >or= 1 unit packed red blood cells (PRBC), or >or= age 65 years with two of three criteria. Patients with brain injury were excluded. Data were recorded prospectively. In 24 months ending July 31, 2006, of 193 patients, 114 (59%) were assigned CVP- directed resuscitation, and 79 (41%) were assigned PAC-directed resuscitation. A subgroup of 11 (10%) initially assigned CVP was reassigned PAC-directed resuscitation (7 +/- 2 h after start) due to hemodynamic instability. Crystalloid fluid and PRBC resuscitation volumes for PAC (8 +/- 1 L lactated Ringer's [LR], 5 +/- 0.4 units PRBC) were > CVP (5 +/- 0.4 L LR, 3 +/- 0.3 units PRBC) and similar to CVP - PAC protocol subgroup patients (9 +/- 2 L LR, 5 +/- 1 units PRBC). Intensive care unit (ICU) stay and survival rate for PAC (18 +/- 2 days, 75%) were similar to CVP - PAC (17 +/- 4 days, 73%) and worse than CVP protocol subgroup patients (9 +/- 1 days, 98%). Traumatic shock resuscitation is feasible using CVP as a primary hemodynamic monitor as part of a protocol that includes explicit definition of hemodynamic instability and where PAC monitoring is readily available. Computerized decision support provides a technique to implement complex protocol care processes and analyze patient response.

Standards in clinical decision support: activities in health level seven.

Health Level Seven (HL7) has evolved into an international standards development organization (SDO) with a suite of standards. Prominent among these are formalisms related to clinical decision support, including the Arden Syntax, GELLO and Decision Support Service (DSS) standards. Continuing improvement in these standards and ongoing development of future decision support standards require wide participation in order to maximize their success. Accordingly, the purpose of the workshop is twofold. First, instructors will convey the latest developments regarding existing decision support standards and related efforts to develop new standards. Second, the instructors will solicit feedback so that attendees who do not participate in HL7 can have input into the standards activities of that organization. The instructors of this workshop, who are the co-chairs and/or members of the Clinical Decision Support Technical Committee of HL7, will review progress in these areas. They will present the details of the ongoing development of the extant Arden Syntax, GELLO and DSS standards. They will discuss work on current draft and proposed future standards, including the Infobutton communication and Order Set standards that are undergoing development in anticipation of certification as standards. Finally, they will solicit discussion regarding the future direction of standards development in these areas.

A proposed clinical decision support system (CDSS) output message.

When a clinical decision support system (CDSS) or other ancillary system detects an abnormal or problematic condition, healthcare providers must be notified in a timely manner so that appropriate corrective action can be taken. Delivery of clinical alerts to the appropriate providers is the role of a notification system.1,2 The content generating system must therefore communicate to the notification system the content to be delivered and any additional directives regarding the resulting notifications. This work is sanctioned by the Health Level Seven, Inc., Clinical Decision Support Technical Committee (CDS TC) and is based on previous proposals to the CDS TC.3 The proposed message model is presented as an XML schema.4

Normal versus supranormal oxygen delivery goals in shock resuscitation: the response is the same.

BACKGROUND: Shock resuscitation is integral to early management of severely injured patients. Our standardized shock resuscitation protocol, developed in 1997 and implemented as a computerized intensive care unit (ICU) bedside decision support tool in 2000, used oxygen delivery index (Do I) > or = 600 mL/min/m as the intervention endpoint. In a recent publication, Shoemaker et al. refuted positive outcome effect of early supranormal Do (i.e., Do I > or = 600) resuscitation. In response to and because of ongoing concern for excessive volume loading, we decreased our Do I endpoint from 600 to 500. Our hypothesis was that by decreasing the Do I endpoint, less crystalloid would be administered. We compare resuscitation responses to the protocol with goals of Do I > or = 600 versus 500 in two patient cohorts. METHODS: A standardized protocol was used to direct bedside decisions for resuscitation of patients with major injury (Injury Severity Score > 15), blood loss (> or = 6 units of packed red blood cells), metabolic stress (base deficit > or = 6 mEq/L), and no severe brain injury. The protocol logic is to attain and maintain Do I > or = a specified goal for the first 24 ICU hours using primarily blood and volume loading. Two cohorts were compared: Do I > or = 500 (18 patients admitted February-August 2001) versus Do I > or = 600 (18 patients admitted during 2000 age and gender matched with the Do I > or = 500 group). Data were analyzed using analysis of variance, chi, and t tests (p < 0.05). RESULTS: Both groups had similar demographics (age 30 +/- 3 years; 78% men; Injury Severity Score 27 +/- 3), hemodynamics, and severity of shock at start of resuscitation in the ICU. Resuscitation response was Do I increase to > or = 600 for both cohorts within approximately 12 hours. Throughout the 24-hour ICU process, the Do I > or = 500 cohort received less lactated Ringer's volume than the Do I > or = 600 cohort (total of 8 +/- 1 vs. 12 +/- 2 L; p < 0.05) and tended to receive less blood transfusion (total of 3 +/- 1 vs. 5 +/- 1 units of packed red blood cells). CONCLUSION: Shock resuscitation using Do I > or = 500 was indistinguishable from Do I > or = 600 mL/min/m. Less volume loading was required to attain and maintain Do I > or = 500 than 600 using computerized protocol technology to standardize resuscitation during the first 24 ICU hours.