Abstract:
OBJECTIVE:We perform an ethical analysis of European Union Directive 2001/20/EC on the simplification and harmonization of guidelines regarding good clinical practice in the conduct of clinical trials involving drugs. BACKGROUND:The Directive provides guidance on protecting incapacitated subjects who participate in drug clinical trials. Such guidance promotes society's obligations of beneficence because the participation of incapacitated subjects in research is crucial in advancing the understanding and treatment of serious diseases. The Directive requires proxy consent for incapacitated subjects which adheres to the principle of respect for persons. The Directive also recommends additional safeguards to further protect subjects against exploitation and harm. These include respect for the assent and dissent of incapacitated subjects and the "necessity" and "subject-condition" requirements. RESULTS:While these essential protection mechanisms are commendable, the Directive fails to endorse other safeguards that have been recommended by other research ethics guidelines, especially for riskier research. The Directive's silence regarding research in the emergency setting frustrates the principle of beneficence because the lack of guidance might prove to be a barrier for the conduct of such potentially beneficial research. CONCLUSIONS:We conclude that the European Directive fails in many respects to promote several important ethical principles in research involving incapacitated subjects.
journal_name
Intensive Care Medjournal_title
Intensive care medicineauthors
Silverman HJ,Druml C,Lemaire F,Nelson R,European Union Directive.doi
10.1007/s00134-004-2367-5keywords:
subject
Has Abstractpub_date
2004-09-01 00:00:00pages
1723-9issue
9eissn
0342-4642issn
1432-1238journal_volume
30pub_type
杂志文章abstract:OBJECTIVES:Previous studies on therapeutic interventions in sepsis have assumed stability of the measure of splanchnic blood flow throughout the study. We assessed the variability of splanchnic blood flow during stable global hemodynamics in eight patients with sepsis requiring treatment with dobutamine and/or norepine...
journal_title:Intensive care medicine
pub_type: 杂志文章
doi:10.1007/s001340100980
更新日期:2001-08-01 00:00:00
abstract:INTRODUCTION:A prospective physiological study was performed in 12 paediatric patients with acute moderate hypercapnic respiratory insufficiency to assess the ability of noninvasive positive pressure ventilation (NPPV) to unload the respiratory muscles and improve gas exchange. MATERIALS AND METHODS:Breathing pattern,...
journal_title:Intensive care medicine
pub_type: 临床试验,杂志文章
doi:10.1007/s00134-008-1202-9
更新日期:2008-12-01 00:00:00
abstract:OBJECTIVE:Definition of the changes in the activators of plasminogen, u-PA and t-PA, and examination of the possible generation of plasmin in the circulation in overwhelming sepsis. DESIGN:Serial blood analysis starting 4 h after development of symptoms of toxic shock syndrome. SETTING:Intensive care unit. PATIENT:A...
journal_title:Intensive care medicine
pub_type: 杂志文章
doi:10.1007/s001340050561
更新日期:1998-03-01 00:00:00
abstract:OBJECTIVE:To assess the safety and efficacy of sustained inflations (SI) as lung recruitment maneuvers (RMs) in ventilated pediatric intensive care unit (PICU) patients. DESIGN:Observational, prospective data collection. SETTING:Tertiary-care PICU. PATIENTS AND PARTICIPANTS:Thirty-two consecutive ventilated pediatri...
journal_title:Intensive care medicine
pub_type: 杂志文章
doi:10.1007/s00134-007-0764-2
更新日期:2007-10-01 00:00:00
abstract:: ...
journal_title:Intensive care medicine
pub_type: 评论,社论
doi:10.1007/s00134-018-5399-y
更新日期:2018-11-01 00:00:00
abstract:PURPOSE:To compare the concentration conformity of infusion solutions manually prepared on intensive care units (ICU) with solutions from pharmacy-based, automated production. METHODS:A prospective observational study conducted in a university hospital in Germany. Drug concentrations of 100 standardised infusion solut...
journal_title:Intensive care medicine
pub_type: 杂志文章
doi:10.1007/s00134-011-2230-4
更新日期:2011-08-01 00:00:00
abstract:BACKGROUND:Limiting the duration of invasive ventilation is an important goal in caring for critically ill patients. Several clinical trials have shown that compared to traditional care, protocols can reduce the total duration of mechanical ventilation. Computerized or automated weaning has the potential to improve wea...
journal_title:Intensive care medicine
pub_type: 杂志文章,评审
doi:10.1007/s00134-008-1154-0
更新日期:2008-10-01 00:00:00
abstract:PURPOSE:Early central venous catheter (CVC) insertion in Ebola virus disease (EVD) is a novel approach and has not previously been described. This report delineates the safety, feasibility and clinical implications of early CVC insertion as the optimum means of vascular access in patients with EVD, in the setting of a ...
journal_title:Intensive care medicine
pub_type: 杂志文章
doi:10.1007/s00134-015-3736-y
更新日期:2015-05-01 00:00:00
abstract:OBJECTIVE:To provide evidence for the upregulation of endothelial nitric oxide synthase (eNOS) or inducible nitric oxide synthase (iNOS) in the assumed imbalance in the pathophysiology of rapid progressive pulmonary hypertension of the newborn (RPPHN), which is characterized by abnormal hypertrophy of the pulmonary art...
journal_title:Intensive care medicine
pub_type: 杂志文章
doi:10.1007/s00134-003-1892-y
更新日期:2003-10-01 00:00:00
abstract:OBJECTIVE:To describe the use of volumetric capnography, a plot of expired CO(2) concentration against expired volume, in monitoring fibrinolytic treatment of major pulmonary embolism. DESIGN AND SETTING:Two case reports in the emergency department of a teaching hospital. PATIENTS:Two conscious and spontaneously brea...
journal_title:Intensive care medicine
pub_type: 杂志文章
doi:10.1007/s00134-004-2444-9
更新日期:2004-11-01 00:00:00
abstract::The case of an 11-year-old boy who suffered second and third degree burns to 78% of his body is reported. The large doses of morphine used as analgesia resulted in severe side effects: ventilatory dependence, impairment of gastrointestinal function and psychological disturbance. Intravenous lignocaine was added withou...
journal_title:Intensive care medicine
pub_type: 杂志文章
doi:10.1007/BF01712245
更新日期:1996-03-01 00:00:00
abstract:OBJECTIVE:To determine the value of procalcitonin (PCT) in the early diagnosis (and differentiation) of patients with SIRS, sepsis, severe sepsis, and septic shock in comparison to C-reactive protein (CRP), white blood cell and thrombocyte count, and APACHE-II score (AP-II). DESIGN:Prospective cohort study including a...
journal_title:Intensive care medicine
pub_type: 杂志文章
doi:10.1007/BF02900728
更新日期:2000-03-01 00:00:00
abstract:OBJECTIVE:Evaluating the prevalence, risk factors and prevention of pressure ulcers in Dutch intensive care units (ICUs). DESIGN:Cross-sectional design. SETTING:ICUs of acute care hospitals that participated in the 1998 and 1999 national prevalence surveys. Data were collected on 1 day in each year. PATIENTS:Eight h...
journal_title:Intensive care medicine
pub_type: 杂志文章
doi:10.1007/s001340101061
更新日期:2001-10-01 00:00:00
abstract:OBJECTIVE:To identify and reduce medication-prescribing errors by introducing systematic physician education and post-cardiac surgery admission prescription forms. DESIGN:Errors were defined as: incomplete prescriptions; potential adverse drug events (ADEs), i.e. either intercepted or non-intercepted incorrect prescri...
journal_title:Intensive care medicine
pub_type: 杂志文章
doi:10.1007/s00134-008-1054-3
更新日期:2008-06-01 00:00:00
abstract:OBJECTIVE:To determine the clinical impact of bedside colonoscopy for critically ill patients with acute lower gastrointestinal (GI) bleeding. DESIGN AND SETTING:A 3-year retrospective analysis (chart review). Medical intensive care unit (ICU) of a 1,312-bed tertiary-care center in Taiwan. PATIENTS AND PARTICIPANTS:F...
journal_title:Intensive care medicine
pub_type: 杂志文章
doi:10.1007/s00134-005-2604-6
更新日期:2005-05-01 00:00:00
abstract:PURPOSE:Extracorporeal membrane oxygenation (ECMO) can support oxygenation and carbon dioxide elimination in severe lung failure. Usually it is accompanied by controlled mechanical ventilation. Neurally adjusted ventilatory assist (NAVA) is a new mode of ventilation triggered by the diaphragmatic electrical activity an...
journal_title:Intensive care medicine
pub_type: 杂志文章
doi:10.1007/s00134-010-1982-6
更新日期:2010-12-01 00:00:00
abstract:OBJECTIVES:To compare the effects of norepinephrine and dobutamine to epinephrine on hemodynamics, lactate metabolism, and gastric tonometric variables in hyperdynamic dopamine-resistant septic shock. DESIGN:A prospective, intervention, randomized clinical trial. SETTING:Adult medical/surgical intensive care unit in ...
journal_title:Intensive care medicine
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1007/s001340050329
更新日期:1997-03-01 00:00:00
abstract::To examine the right ventricular response to acute respiratory failure, serial studies of biventricular performance were analysed in 34 such patients, specifically detailing the role of associated underlying disease. During the initial study, the 34 patients with acute respiratory failure had a higher right ventricula...
journal_title:Intensive care medicine
pub_type: 杂志文章
doi:10.1007/BF00256963
更新日期:1988-01-01 00:00:00
abstract:OBJECTIVE:Measurement of functional residual capacity (FRC) during mechanical ventilation is important to standardise respiratory system compliance and adjust the ventilator settings to optimise lung recruitment. In the present study we compared three methods to measure FRC. DESIGN:The bias flow nitrogen washout techn...
journal_title:Intensive care medicine
pub_type: 杂志文章
doi:10.1007/s00134-003-2028-0
更新日期:2004-01-01 00:00:00
abstract:OBJECTIVE:The efficacy of interferon gamma therapy in reducing infection and improving outcome from infection in patients sustaining major injury was examined. DESIGN:Randomized double-blind placebo control trial SETTING:Nine level one university affiliated trauma centers in the United States. PATIENTS AND PARTICIPA...
journal_title:Intensive care medicine
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1007/BF01743725
更新日期:1996-10-01 00:00:00
abstract:PURPOSE:Acute heart failure (AHF) causes high burden of mortality, morbidity, and repeated hospitalizations worldwide. This guidance paper describes the tailored treatment approaches of different clinical scenarios of AHF and CS, focusing on the needs of professionals working in intensive care settings. RESULTS:Tissue...
journal_title:Intensive care medicine
pub_type: 杂志文章,评审
doi:10.1007/s00134-015-4041-5
更新日期:2016-02-01 00:00:00
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journal_title:Intensive care medicine
pub_type: 杂志文章
doi:10.1007/s00134-011-2390-2
更新日期:2012-01-01 00:00:00
abstract::Activation of the complement system within the lung can lead to acute pulmonary damage and dysfunction. Based on a variety of experimental models it is now apparent that lung injury is related to complement-induced generation of oxygen derived free radicals from neutrophils and from macrophages. In addition to the oxy...
journal_title:Intensive care medicine
pub_type: 杂志文章
doi:10.1007/BF00315362
更新日期:1986-01-01 00:00:00
abstract:PURPOSE:The early diagnosis of traumatic internal carotid artery dissection (TICAD) is essential for initiating appropriate treatment and improving outcome. We searched for criteria from transcranial Doppler (TCD) measurements on admission that could be associated with subsequent TICAD diagnosis in patients with trauma...
journal_title:Intensive care medicine
pub_type: 杂志文章
doi:10.1007/s00134-010-1919-0
更新日期:2010-09-01 00:00:00
abstract:OBJECTIVE:The evaluation of incidences and relating factors of severe persisting critical illness polyneuropathy (CIP) in survivors of multiple organ failure (MOF). DESIGN:Prospective study with an entry period of 24 months. Electrophysiological studies for the diagnosis of CIP were performed 1 or 2 days before the pa...
journal_title:Intensive care medicine
pub_type: 杂志文章
doi:10.1007/s001340050471
更新日期:1997-11-01 00:00:00
abstract:OBJECTIVE:In normal subjects cerebral CO2 vasoreactivity is measured during spontaneous hyperventilation, breathholding, or adding CO2 to inspiratory gases. The correlation between CO2 and cerebral blood flow may, however, be invalidated by the effects of a modified respiratory pattern on venous return, sympathovagal b...
journal_title:Intensive care medicine
pub_type: 临床试验,杂志文章
doi:10.1007/s001340051239
更新日期:2000-06-01 00:00:00
abstract::A case of metabolic acidosis, acute renal failure and hepatic failure following paracetamol ingestion is presented. The diagnostic difficulty at presentation is highlighted. Continuous arteriovenous haemofiltration proved a valuable means of maintaining fluid and electrolyte balance. The patient recovered. ...
journal_title:Intensive care medicine
pub_type: 杂志文章
doi:10.1007/BF00262905
更新日期:1988-01-01 00:00:00
abstract:OBJECTIVE:The primary objective was to test the hypothesis that clinical re-expansion pulmonary edema is predominantly due to increased permeability of the alveolar-capillary barrier. A secondary objective was to determine if the alveolar epithelium was functionally intact in patients with re-expansion pulmonary edema ...
journal_title:Intensive care medicine
pub_type: 杂志文章
doi:10.1007/s00134-004-2379-1
更新日期:2004-10-01 00:00:00
abstract::Membranous laryngotracheobronchitis is a very serious infection which affects the larynx, trachea and bronchi, requiring aggressive therapeutic measures. It has been recently rediscovered as a cause of disease in children. However, it is a very unusual complication of measles. Two infants with measles and membranous l...
journal_title:Intensive care medicine
pub_type: 杂志文章
doi:10.1007/BF00273547
更新日期:1985-01-01 00:00:00
abstract::We report a case of fatal septic shock, with hyperlactatemia and blood cultures positive for Streptococcus pneumoniae, in a 70-year-old patient. On two occasions (5 days, and 2 days before the patient's death), the relationship between oxygen delivery (DO2) and consumption (VO2) was examined in conjunction with two pr...
journal_title:Intensive care medicine
pub_type: 杂志文章
doi:10.1007/s001340050300
更新日期:1997-01-01 00:00:00