Abstract:
OBJECTIVE:To examine the frequency of obtaining Institutional Review Board (IRB) approval and informed consent in critical care research. DATA SOURCES AND DATA EXTRACTION:One-year retrospective review of original critical care research in humans published in seven journals, including American Journal of Respiratory and Critical Care Medicine, Chest, Critical Care Medicine, Intensive Care Medicine, The Journal of the American Medical Association, Lancet, and The New England Journal of Medicine. Studies were examined for general information (country/state where the research was performed, affiliation of the hospital to a medical school, and whether the work was supported by a grant and specifically by a pharmaceutical company), approval by IRB, method of consent, design of research, and interventions involved in the study. DATA SYNTHESIS:Two hundred seventy-nine studies were reviewed, 124 (44%) of which were conducted in the United States. Two hundred forty-three (87%) studies were performed in a university institution, 96 (34%) studies were supported by a grant, and 23 (24%) studies were supported by a pharmaceutical company. In 66 (24%) studies, there was no evidence of IRB review and informed consent approval. IRB approval was obtained but the method of consent was not specified in 36 (13%) studies. No significant differences were found in obtaining IRB approval and informed consent between research conducted in the United States (n=71, 57%) or outside the United States (n=92, 59%). Grant support was obtained in ten (9%) of the 116 studies not fully approved, compared with 70 (50%) of the 140 studies that obtained full approval (p < .05). All studies (23) supported by the pharmaceutical industry were fully approved. CONCLUSIONS:Many published studies in critical care lack IRB approval and/or informed consent. All research supported by the pharmaceutical industry was fully approved. The findings raise ethical concerns about critical care research.
journal_name
Crit Care Medjournal_title
Critical care medicineauthors
Matot I,Pizov R,Sprung CLdoi
10.1097/00003246-199809000-00035subject
Has Abstractpub_date
1998-09-01 00:00:00pages
1596-602issue
9eissn
0090-3493issn
1530-0293journal_volume
26pub_type
杂志文章abstract:OBJECTIVE:To define the relative needs of the staffs of rural, community hospitals for training in advanced cardiac life support (ACLS), identify weaknesses, and modify a standard ACLS course to meet these needs. DESIGN:Prospective assessment of knowledge and skills relating to the practice of ACLS. SETTING:Rural, co...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/00003246-199405000-00006
更新日期:1994-05-01 00:00:00
abstract:OBJECTIVE:The requirement for a blood transfusion after trauma is associated with an increased risk of acute lung injury. Residual leukocytes contaminating red cells are potential mediators of this syndrome. The goal of this trial was to test our hypothesis that prestorage leukoreduction of blood would reduce rates of ...
journal_title:Critical care medicine
pub_type: 杂志文章,随机对照试验
doi:10.1097/CCM.0b013e318170a9ce
更新日期:2008-05-01 00:00:00
abstract:OBJECTIVES:Hyponatremia occurs in up to 30% of patients with pneumonia and is associated with increased morbidity and mortality. The prevalence of hyponatremia associated with coronavirus disease 2019 and the impact on outcome is unknown. We aimed to identify the prevalence, predictors, and impact on outcome of mild, m...
journal_title:Critical care medicine
pub_type: 杂志文章,多中心研究
doi:10.1097/CCM.0000000000004605
更新日期:2020-12-01 00:00:00
abstract:OBJECTIVE:Restoration of myocardial blood flow after ischemia triggers an inflammatory response involving toll-like receptors. Toll-like receptor 2 deficiency is associated with a reduced infarct size after myocardial ischemia and reperfusion. Because a marked mortality was observed in C3HeN wild-type mice, which was a...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/CCM.0b013e3181ef455b
更新日期:2010-10-01 00:00:00
abstract:OBJECTIVES:To determine whether aerosolized antibiotics can be delivered efficiently to the lower respiratory tract in mechanically ventilated patients and to define possible clinical responses to these agents. DESIGN:Prospective serial study with cases as their own control. SETTING:A 10-bed respiratory care unit for...
journal_title:Critical care medicine
pub_type: 临床试验,杂志文章
doi:10.1097/00003246-199801000-00013
更新日期:1998-01-01 00:00:00
abstract:OBJECTIVE:The objective of this study was to test the ability of myoglobin removal of a novel, high-permeability polysulphone dialyzer in acute kidney injury as a result of rhabdomyolysis. SETTING:Intensive care unit of a tertiary care hospital. PATIENTS:Six patients (one female; aged 24, 36, 41, 55, 63, and 65 yrs) ...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/CCM.0b013e3181feb7f0
更新日期:2011-01-01 00:00:00
abstract:OBJECTIVES:To determine whether glucose utilization and metabolic substrate (glucose and fat) oxidation could be manipulated in patients with secondary multiple organ dysfunction syndrome. DESIGN:Prospective study. SETTING:Intensive care units (ICU) of two university hospitals. PATIENTS:Eight adults free of hepatic ...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/00003246-199501000-00014
更新日期:1995-01-01 00:00:00
abstract::Two new catecholamines, dopamine and dobutamine, have found widespread use for cardiovascular support. The relative efficacy of these drugs in aiding resuscitation from cardiopulmonary arrest is unknown. Dogs were subjected to either asphyxial or fibrillatory cardiac arrest. Resuscitation was attempted with artificial...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/00003246-198109000-00005
更新日期:1981-09-01 00:00:00
abstract::The authors determined the correction factor (Ct) for three sizes of commonly available central venous catheters. These catheters are used as the injectate catheter when a 2.5 Fr transthoracic thermistor is used to determine cardiac output by thermodilution. The valves for Ct were highly reproducible. These determinat...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/00003246-198112000-00014
更新日期:1981-12-01 00:00:00
abstract::Subcutaneous, transcutaneous, and conjunctival oxygen tensions (PscO2, PtcO2, and PcjO2, respectively) were measured in anesthetized dogs subjected sequentially to normoxia, hyperoxia, and hypoxia. Intravascular pressure, hemodynamic and oxygen transport variables were measured simultaneously. PtcO2 and PcjO2 closely ...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/00003246-198812000-00011
更新日期:1988-12-01 00:00:00
abstract::Colloid osmotic pressure (COP) was measured simultaneously with cardiorespiratory measurements in 103 surgical patients suspected of having circulatory problems. In a small subset of 28 patients, measurements were taken before, during, and after surgical operations. Similarly, data sets were taken before, during, and ...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/00003246-198303000-00010
更新日期:1983-03-01 00:00:00
abstract:OBJECTIVE:To investigate the interaction and involvement of hydrogen sulfide and transient receptor potential vanilloid type 1 in the pathogenesis of sepsis. Hydrogen sulfide has been demonstrated to be involved in many inflammatory states including sepsis. Its contribution in neurogenic inflammation has been suggested...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/CCM.0b013e3181c0df00
更新日期:2010-02-01 00:00:00
abstract:OBJECTIVE:Granulocyte colony-stimulating factor is widely prescribed to hasten recovery from cancer chemotherapy-induced neutropenia and has been reported to induce pulmonary toxicity. However, circumstances and mechanisms of this toxicity remain poorly known. DESIGN:To reproduce a routine situation in cancer patients...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/00003246-200209000-00027
更新日期:2002-09-01 00:00:00
abstract:OBJECTIVE:To establish the effect of an audible airleak (around an endotracheal tube) on oxygen consumption (VO2) measurements in pediatric ICU patients. DESIGN:Prospective trial comparing VO2 measurements before and after deflation of the endotracheal tube cuff. SETTING:Pediatric ICU in a large pediatric tertiary ca...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/00003246-199206000-00012
更新日期:1992-06-01 00:00:00
abstract:OBJECTIVE:To define the impact of prehospital hypotension on the dynamic, systemic acute inflammatory response to blunt trauma. DESIGN:Retrospective study. SETTINGS:Tertiary care institution. PATIENTS:Twenty-two hypotensive blunt trauma patients matched with 28 normotensive blunt trauma patients. INTERVENTION:None....
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/CCM.0000000000000964
更新日期:2015-07-01 00:00:00
abstract:OBJECTIVE:Within minutes of reperfusing ischemic cardiomyocytes, oxidant stress dramatically increases and is associated with postresuscitation injury. Because mitochondria produce deleterious oxidants and useful metabolic substrates, utilization of electron transport chain inhibitors against reperfusion injury, though...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/01.CCM.0000246014.19486.A1
更新日期:2006-12-01 00:00:00
abstract:OBJECTIVE:Our first objective was to determine a blood lactate threshold predictive of survival in human immunodeficiency virus patients experiencing lactic acidosis related to nucleoside analogs, and second, to test l-carnitine for the treatment of patients exceeding that threshold. DESIGN:a) Retrospective study usin...
journal_title:Critical care medicine
pub_type: 临床试验,杂志文章,多中心研究
doi:10.1097/01.CCM.0000053649.69377.08
更新日期:2003-04-01 00:00:00
abstract::Acute kidney injury (AKI) is commonly and increasingly encountered in patients with critical illness. In the past, epidemiologic studies have consistently found that oliguria further increases the risk of death from AKI. Compared with patients outside the intensive care unit (ICU), critically ill patients are more lik...
journal_title:Critical care medicine
pub_type: 杂志文章,评审
doi:10.1097/CCM.0b013e318168c92f
更新日期:2008-04-01 00:00:00
abstract:OBJECTIVES:The aim of this study was to evaluate the efficacy of perioperative intra-aortic balloon pump use in high-risk cardiac surgery patients. DESIGN:A single-center randomized controlled trial and a meta-analysis of randomized controlled trials. SETTING:Heart Institute of São Paulo University. PATIENTS:High-ri...
journal_title:Critical care medicine
pub_type: 杂志文章,随机对照试验
doi:10.1097/CCM.0000000000003185
更新日期:2018-08-01 00:00:00
abstract:OBJECTIVE:The aim of this study was to investigate whether hyperglycemia enhances the systemic inflammatory response and oxidative stress induced by endotoxin. DESIGN:Laboratory investigation. SETTING:University medical school. SUBJECTS:Forty-one male Sprague-Dawley rats. INTERVENTIONS:A hyperglycemic condition was...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/01.ccm.0000163225.88827.63
更新日期:2005-05-01 00:00:00
abstract::To understand better the incidence and meaning of hyperamylasemia in the intensive care setting, cellulose acetate membrane electrophoresis was used to measure the isoenzymes of serum amylase in 192 patients with a variety of critical illnesses. Seventy of these patients had elevated serum amylase levels, but none had...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/00003246-198507000-00003
更新日期:1985-07-01 00:00:00
abstract::Recent strides in computational biology and high-throughput technologies have generated considerable interest in understanding complex biological systems. The application of these technologies to critical illness and injury offers the potential to define adaptive and maladaptive programs of gene expression induced by ...
journal_title:Critical care medicine
pub_type: 杂志文章,评审
doi:10.1097/ccm.0b013e318186a720
更新日期:2008-10-01 00:00:00
abstract:OBJECTIVES:To outline both the preclinical and clinical data demonstrating surfactant alterations in acute lung injury, which provide the rationale for testing exogenous surfactant administration in this setting. We also review the results of the randomized, controlled clinical trials conducted to date that have evalua...
journal_title:Critical care medicine
pub_type: 杂志文章,评审
doi:10.1097/01.CCM.0000057911.19145.9F
更新日期:2003-04-01 00:00:00
abstract::The need for closed-loop control of blood pressure in acute hypertension after cardiac surgery was evaluated by estimating the amount of nurse-time required to adjust the infusion rate of sodium nitroprusside. The evaluation consisted of a nationwide telephone survey of head nurses in postsurgical ICUs at 9 institutio...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/00003246-198212000-00005
更新日期:1982-12-01 00:00:00
abstract:OBJECTIVE:Cardiogenic shock remains an important therapeutic challenge, with high in-hospital mortality rates. Mechanical circulatory support may be beneficial in these patients. Since the efficacy of the intra-aortic balloon pump seems limited, new percutaneously placed mechanical left ventricular support devices, suc...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/CCM.0b013e31821e89b5
更新日期:2011-09-01 00:00:00
abstract:BACKGROUND AND METHODS:This study was designed to test whether dopexamine, a dopaminergic and beta 2-adrenergic agonist, would a) increase systemic oxygen delivery (DO2) in endotoxic dogs, and b) interfere with the ability of resting skeletal muscle to extract oxygen. There were three treatment groups (n = 6 in each gr...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/00003246-199102000-00015
更新日期:1991-02-01 00:00:00
abstract:OBJECTIVES:To investigate family perceptions of having a nurse participating in family conferences and to assess the psychologic well being of the same families after ICU discharge. DESIGN:Mixed-method design with a qualitative study embedded in a single-center randomized study. SETTING:Twelve-bed medical-surgical IC...
journal_title:Critical care medicine
pub_type: 杂志文章,随机对照试验
doi:10.1097/CCM.0000000000001632
更新日期:2016-06-01 00:00:00
abstract:OBJECTIVES:Prophylactic levetiracetam is currently used in ~40% of patients with intracerebral hemorrhage, and the potential impact of levetircetam on health-related quality of life is unknown. We tested the hypothesis that prophylactic levetiracetam is independently associated with differences in cognitive function he...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/CCM.0000000000003272
更新日期:2018-09-01 00:00:00
abstract::Arterial catheterization for blood gas analysis and direct monitoring of blood pressure in infants and children can be attended by a variety of complications, which limit its use to short periods of time. An improved technique, consisting of elimination of stopcocks, the use of a continuous flushing system adapted for...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/00003246-197605000-00010
更新日期:1976-05-01 00:00:00
abstract:OBJECTIVES:Critical care ultrasonography has become established within ICUs as a diagnostic tool and to guide management strategies and practical procedures. Following an international consensus statement in 2011, various national professional societies and organizations have sought to develop and deliver training prog...
journal_title:Critical care medicine
pub_type: 杂志文章
doi:10.1097/CCM.0000000000003626
更新日期:2019-03-01 00:00:00