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Biomedical subjects

C L Sprung

Publications and source records attributed to C L Sprung.

At least 55 records · Page 3Linked to original sources
PubMed1997

The issue of a U.S. Food and Drug Administration moratorium on the use of the pulmonary artery catheter.

OBJECTIVE: To review the literature addressing the issue of a U.S. Food and Drug Administration (FDA) moratorium on use of the pulmonary artery catheter (PAC). DATA SOURCE: Pertinent English language articles dealing with medical devices including the PAC were retrieved from 1976 through 1996. STUDY SELECTION: Articles were chosen if issues related to medical devices were studied or reviewed. DATA EXTRACTION: From the articles selected, information about the 1976 Medical Device Amendment and the PAC was obtained. DATA SYNTHESIS: In 1976, the Medical Device Amendment gave the FDA power over medical devices. The pulmonary artery catheter is considered a class II device and was on the market before passage of the 1976 Act. Class II devices require general and specific controls to reasonably assure safety and effectiveness. A reasonable assurance of safety occurs when the probable benefits to health from the use of the device outweigh any probable risks. If a monitor measures an established and well-understood variable and the intended use claim is limited to the measurement of that variable, then the effectiveness consists of determining device safety and performance defined as the measurement of agreement with a recognized reference method. Deaths and serious injuries secondary to pulmonary artery catheterization are extremely rare despite more than 25 years of use. Pulmonary artery catheter manufacturer's indications for use are measurements such as hemodynamic pressures, thermodilution cardiac output, continuous cardiac output, mixed venous oxygen saturation, and blood sampling; intended uses have not included claims of clinical benefit. Evidence exists that pulmonary artery catheterization provides agreement with established measurements including pressure and cardiac output. Evidence also exists that pulmonary artery catheter derived data are unobtainable clinically, that the derived data helps in therapy changes and may lead to more appropriate therapy. The evidence demonstrates an absence of unreasonable risk of injury from pulmonary artery catheterization and provision of important clinical results. Therefore, pulmonary artery catheterization meets FDA requirements for safety and effectiveness. CONCLUSION: An FDA moratorium on the use of the PAC is not indicated.

Catheterization, Swan-Ganz↗
PubMed1996

The spectrum of septic encephalopathy. Definitions, etiologies, and mortalities.

OBJECTIVE: To determine whether the severity of septic encephalopathy is correlated with gram-negative bacteremia and mortality and whether there exists a single or combination of metabolic derangements(s) that cause septic encephalopathy. DESIGN AND SETTING: Prospective case series in an academic medical center. PATIENTS: Fifty patients selected according to clinical and laboratory criteria for severe sepsis. The criteria included temperature, heart rate, respiratory rate, and hypotension and/or signs of systemic hypoperfusion. MAIN OUTCOME MEASURES: A single or combination of metabolic and laboratory derangements and organ failures, three different methods to grade the severity of septic encephalopathy, Acute Physiology and Chronic Health Evaluation II (APACHE II) scores, gram-negative bacteremia and infection, and mortality. RESULTS: Encephalopathy was associated with an increase in mortality when graded by the Glasgow Coma Score; a score of 15 had 16% mortality, 13 to 14 had 20%, 9 to 12 had 50%, and 3 to 8 had 63% mortality (P < .05). Bacteremia was associated with encephalopathy; 13% of septic patients without encephalopathy vs 59% of patients with encephalopathy had bacteremia (P < .001) when graded by altered mental status. Septic encephalopathic patients had elevated serum urea nitrogen and bilirubin levels, increased APACHE II scores, and a higher incidence of renal failure. CONCLUSIONS: The severity of septic encephalopathy correlated with mortality, bacteremia, and renal and hepatic dysfunction. The Glasgow Coma Score is a useful tool for characterizing septic encephalopathy. Considerable variations can be found according to different criteria used to classify septic encephalopathy.

APACHE↗
PubMed1996

Euthanasia.

This article provides a brief review of the history of euthanasia. The problems involved in withholding or withdrawing treatment, physician-assisted suicide, and arguments for or against euthanasia are discussed. Changes in both societal and physician attitudes and practices are presented.

Europe↗
PubMed1996

The Swan-Ganz catheter. Twenty-five years of monitoring.

The years that have passed since the introduction of the pulmonary artery catheter have been marked by radical changes in the practice of general and critical care medicine. There has been an increase in the application of physiologic principles to the management of shock states, myocardial infarction, and respiratory failure. These developments have caused an increase in the expectations of patients and physicians alike and in the general preparedness to offer critical care to extremely aged or infirmed patients.

Catheterization, Swan-Ganz↗
PubMed1996

International sepsis trial (INTERSEPT): role and impact of a clinical evaluation committee.

OBJECTIVE: Several large clinical trials have recently evaluated a variety of potential therapeutic interventions for sepsis and have yielded negative results based on analyses of intention-to-treat cohorts. The present study was undertaken to evaluate the importance of a Clinical Evaluation Committee. DESIGN: Prospective, double-blind evaluation of a prospective, controlled, double-blind, randomized, multinational trial. SETTING: Forty medical centers. PATIENTS: Five hundred fifty-three infused patients with severe sepsis and septic shock. METHODS: As part of an international trial (INTERSEPT) of antitumor necrosis factor therapy, a Scientific Extramural Review Committee prospectively defined and excluded patients with confounding events that objectively interfered with the potential of any intervention for sepsis to exercise its therapeutic effect. These confounding events included inappropriate antimicrobial therapy, inadequate medical-surgical management, underlying disorders, and forgoing life-sustaining therapies before management had failed. Patients who met all inclusion and exclusion criteria and who had no confounding events were defined as the Scientific Extramural Review Committee group. MEASUREMENTS AND MAIN RESULTS: Five hundred fifty-three patients were enrolled in INTERSEPT. Seventy-seven patients did not meet inclusion and exclusion criteria. Sixty patients had confounding events, including inappropriate antimicrobial therapy (n = 28), inadequate medical-surgical management (n = 16), underlying disorders (n = 17), and forgoing life-sustaining therapies (n = 7). Four hundred sixteen patients were in the Scientific Extramural Review Committee group and their mortality rates were different from the mortality rates of the intent-to-treat cohort. In the intent-to-treat analysis among shock patients, low-dose anti-tumor necrosis factor reduced 28-day mortality by 14.5% (p = .34), whereas in the Scientific Extramural Review Committee group, the study drug reduced mortality by 26.5% (p = .16). More patients in the high dose anti-tumor necrosis factor treatment arm (31/176) were in the invalid Scientific Extramural Review Committee group than in the other two arms (16/157 and 13/143, respectively, p < .05). CONCLUSIONS: In large trials of sepsis, in addition to analyzing the intent-to-treat cohort, patients in compliance with the protocol and with no confounding events should also be analyzed. These results should assist in determining whether treatment groups are comparable and provide a greater likelihood of demonstrating the potential efficacy of a new therapy for sepsis. A Clinical Evaluation Committee is important to properly assess a clinical sepsis trial.

Adult↗
PubMed1995

Living related donation in lung transplantation. Ethical considerations.

Lung transplantation has become an established rescue therapy for patients with end-stage disease. The major problem, however, is the shortage of organ donors. Living related donation has been successful in kidney and liver transplantation and, recently, in lobar lung transplantation as well. The main ethical dilemma is whether we should risk a parent family member in order to save a child or relative. This dilemma can be taken to the extreme in a case in which pneumonectomy from a live donor can save a patient who is in need of single lung transplantation, a procedure that has not yet been performed, although technically feasible. We discuss the ethical aspects of such a procedure from the perspectives of the donor, the recipient, and the medical team.

Beneficence↗
PubMed1995

A look into the nature and causes of human errors in the intensive care unit.

OBJECTIVES: The purpose of this study was to investigate the nature and causes of human errors in the intensive care unit (ICU), adopting approaches proposed by human factors engineering. The basic assumption was that errors occur and follow a pattern that can be uncovered. DESIGN: Concurrent incident study. SETTING: Medical-surgical ICU of a university hospital. MEASUREMENTS AND MAIN RESULTS: Two types of data were collected: errors reported by physicians and nurses immediately after an error discovery; and activity profiles based on 24-hr records taken by observers with human engineering experience on a sample of patients. During the 4 months of data collection, a total of 554 human errors were reported by the medical staff. Errors were rated for severity and classified according to the body system and type of medical activity involved. There was an average of 178 activities per patient per day and an estimated number of 1.7 errors per patient per day. For the ICU as a whole, a severe or potentially detrimental error occurred on the average twice a day. Physicians and nurses were about equal contributors to the number of errors, although nurses had many more activities per day. CONCLUSIONS: A significant number of dangerous human errors occur in the ICU. Many of these errors could be attributed to problems of communication between the physicians and nurses. Applying human factor engineering concepts to the study of the weak points of a specific ICU may help to reduce the number of errors. Errors should not be considered as an incurable disease, but rather as preventable phenomena.

Ergonomics↗
PubMed1995

Multiple organ dysfunction score: a reliable descriptor of a complex clinical outcome.

OBJECTIVE: To develop an objective scale to measure the severity of the multiple organ dysfunction syndrome as an outcome in critical illness. DESIGN: Systematic literature review; prospective cohort study. SETTING: Surgical intensive care unit (ICU) of a tertiary-level teaching hospital. PATIENTS: All patients (n = 692) admitted for > 24 hrs between May 1988 and March 1990. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Computerized database review of MEDLINE identified clinical studies of multiple organ failure that were published between 1969 and 1993. Variables from these studies were evaluated for construct and content validity to identify optimal descriptors of organ dysfunction. Clinical and laboratory data were collected daily to evaluate the performance of these variables individually and in aggregate as an organ dysfunction score. Seven systems defined the multiple organ dysfunction syndrome in more than half of the 30 published reports reviewed. Descriptors meeting criteria for construct and content validity could be identified for five of these seven systems: a) the respiratory system (Po2/FIO2 ratio); b) the renal system (serum creatinine concentration); c) the hepatic system (serum bilirubin concentration); d) the hematologic system (platelet count); and e) the central nervous system (Glasgow Coma Scale). In the absence of an adequate descriptor of cardiovascular dysfunction, we developed a new variable, the pressure-adjusted heart rate, which is calculated as the product of the heart rate and the ratio of central venous pressure to mean arterial pressure. These candidate descriptors of organ dysfunction were then evaluated for criterion validity (ICU mortality rate) using the clinical database. From the first half of the database (the development set), intervals for the most abnormal value of each variable were constructed on a scale from 0 to 4 so that a value of 0 represented essentially normal function and was associated with an ICU mortality rate of < 5%, whereas a value of 4 represented marked functional derangement and an ICU mortality rate of > or = 50%. These intervals were then tested on the second half of the data set (the validation set). Maximal scores for each variable were summed to yield a Multiple Organ Dysfunction Score (maximum of 24). This score correlated in a graded fashion with the ICU mortality rate, both when applied on the first day of ICU admission as a prognostic indicator and when calculated over the ICU stay as an outcome measure. For the latter, ICU mortality was approximately 25% at 9 to 12 points, 50% at 13 to 16 points, 75% at 17 to 20 points, and 100% at levels of > 20 points. The score showed excellent discrimination, as reflected in areas under the receiver operating characteristic curve of 0.936 in the development set and 0.928 in the validation set. The incremental increase in scores over the course of the ICU stay (calculated as the difference between maximal scores and those scores obtained on the first day [i.e., the delta Multiple Organ Dysfunction Score]) also demonstrated a strong correlation with the ICU mortality rate. In a logistic regression model, this incremental increase in scores accounted for more of the explanatory power than admission severity indices. CONCLUSIONS: This multiple organ dysfunction score, constructed using simple physiologic measures of dysfunction in six organ systems, mirrors organ dysfunction as the intensivist sees it and correlates strongly with the ultimate risk of ICU mortality and hospital mortality. The variable, delta Multiple Organ Dysfunction Score, reflects organ dysfunction developing during the ICU stay, which therefore is potentially amenable to therapeutic manipulation. (ABSTRACT TRUNCATED)

Humans↗
PubMed1994

HA-1A in septic patients with ARDS: results from the pivotal trial.

OBJECTIVE: To evaluate the effects of HA-1A, a human monoclonal antiendotoxin antibody, in septic patients with ARDS. DESIGN: Substudy of a multicenter, double-blinded, placebo-controlled trial of HA-1A in septic patients. PATIENTS: 63 septic patients with ARDS at the time of study entry. INTERVENTION: A single intravenous injection of HA-1A (100 mg) or placebo. RESULTS: A quantitative radiographic score, the PaO2/FIO2 ratio and an index of the severity of ARDS did not show a significant difference between the treatment and placebo groups at 3, 5 and 7 days after treatment. The duration of endotracheal intubation did not differ between the two groups. 15 of 30 HA-1A treated patients (50%) and 23 of 33 placebo-treated patients (69.7%) died within 28 days. The daily mortality was always lower in the HA-1A group, but this difference was not statistically significant at 28 days. The 28-day survival curves for the two treatment groups adjusted by covariate analysis were not significantly different (p = 0.07). Using logistic regression, a significant independent effect of HA-1A treatment was detected upon the early survival rate at 7 days (p = 0.03) but not at 14 and 28 days. CONCLUSION: A single injection of HA-1A in septic patients with ARDS did not reverse acute respiratory failure or improve long-term survival.

Adult↗
PubMed1994

An evaluation of the hemodynamic effects of HA-1A human monoclonal antibody.

OBJECTIVES: We sought to determine whether there might be acute changes in hemodynamics attributable to HA-1A, a monoclonal antibody to endotoxin, in patients with presumed Gram-negative sepsis. DESIGN: Post hoc analysis of a multicenter, randomized, double-blind, placebo-controlled study. PATIENTS: A total of 543 patients with severe sepsis presumed to be caused by Gram-negative bacteria who were enrolled in a clinical trial to evaluate the efficacy and safety of HA-1A human monoclonal antibody. INTERVENTIONS: Patients were randomly assigned to receive either 100 mg of HA-1A or placebo. MEASUREMENT AND MAIN RESULTS: Patients were grouped by the study drug, HA-1A, or placebo, and the presence or absence of Gram-negative bacteremia. Hemodynamic variables were monitored from before, until 72 hrs after infusion of the study drug. For the entire study population (n = 543), no changes over time attributable to study drug were noted in the mean arterial pressure (p > .19), heart rate (p > .53) or the need for vasopressor administration (p > .62). One hundred ninety-seven patients underwent pulmonary artery catheterization and had hemodynamic data available from before the infusion of HA-1A or placebo until at least 12 hrs after infusion. Evaluating all 197 patients on an intent to treat basis demonstrated no significant differences over time in cardiac index (p > .15), oxygen delivery index (p > .43), or left ventricular stroke work index (p > .48) between patients who received HA-1A and those patients receiving placebo. Grouping patients by the presence of Gram-negative bacteremia and study drug received also failed to demonstrate any significant difference attributable to HA-1A in mean arterial pressure (p > .54), heart rate (p > .84), cardiac index (p > .13), oxygen delivery index (p > .05), or left ventricular stroke work index (p > .48) between populations. CONCLUSION: There is no apparent relationship between the administration of HA-1A, the presence of Gram-negative bacteremia, and hemodynamic profiles over the 72-hr study period.

Antibodies, Monoclonal↗