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The ethical conduct of clinical research involving critically ill patients in the United States and Canada: principles and recommendations.
Luce JM, Cook DJ, Martin TR, Angus DC, Boushey HA, Curtis JR, Heffner JE, Lanken PN, Levy MM, Polite PY, Rocker GM, Truog RD; American Thoracic Society.
Publication Types:
- Guideline
- Practice Guideline
PMID: 15590885 [PubMed - indexed for MEDLINE]
[Necessity and problems with case-related costing for intensive care patients.]
[Article in German]
Weiss M, Martin J, Feser U, Schafmayer C, Bauer M.
Universitatsklinik fur Anasthesiologie, Universitatsklinikum, Ulm.
To evaluate whether a German refined diagnosis-related groups (GR-DRGs)-based reimbursement of hospitals/departments covers costs per case, total cost per case accounting is necessary. The aim of the present paper is to delineate the necessity and problems with costs per case accounting for intensive care medicine. The new performance category 8-980 "complex intensive care treatment", in force from 2005 onwards, was integrated into the OPS catalogue to document intensive care work. Whether this will lead to more achievement-oriented cost accounting, has to be demonstrated by the calculations of the institute for reimbursement in hospitals. Basic financing of hospital allowance on a daily basis should be supplemented by extra charges due to analytical concepts of personnel share and to cost-consuming organ replacement procedures. This might lead to a more achievement-oriented cost accounting per case in the ICU.
PMID: 15682331 [PubMed - as supplied by publisher]
 
Implementation of recommendations for the care of children in UK emergency departments: national postal questionnaire survey.
Salter R, Maconochie IK.
Department of Paediatric Accident and Emergency, St Mary's Hospital, London W2 1NY. beckyparas@aol.com
PMID: 15579478 [PubMed - indexed for MEDLINE]
Comment on:
ICU care at the end of life.
Wood KA, Marik PE.
Publication Types:
PMID: 15539702 [PubMed - indexed for MEDLINE]
Comment on:
Futility in stroke care-still a concept in progress.
Mirsen TR.
Publication Types:
- Comment
- Editorial
- Review
- Review, Tutorial
PMID: 15640667 [PubMed - indexed for MEDLINE]
Comment on:
Impact of intensivists on outcome of critically ill neurologic and neurosurgical patients.
Gore DC, Prough DS.
Publication Types:
- Comment
- Editorial
- Review
- Review, Tutorial
PMID: 15640666 [PubMed - indexed for MEDLINE]
Comment on:
New insight from the interplay between nitric oxide and glucocorticoids.
Suzuki H.
Publication Types:
- Comment
- Editorial
- Review
- Review, Tutorial
PMID: 15640665 [PubMed - indexed for MEDLINE]
Comment on:
Limiting deleterious cross-talk between failing organs.
Molls RR, Rabb H.
Publication Types:
- Comment
- Editorial
- Review
- Review, Tutorial
PMID: 15640663 [PubMed - indexed for MEDLINE]
Comment on:
Granulocyte colony stimulating factor: just another neuroprotectant?
Kollmar R, Schwab S.
Publication Types:
- Comment
- Editorial
- Review
- Review, Tutorial
PMID: 15640662 [PubMed - indexed for MEDLINE]
Comment on:
Incident reporting in the information age.
Dominguez TE, Portnoy JD.
Publication Types:
- Comment
- Editorial
- Review
- Review, Tutorial
PMID: 15640657 [PubMed - indexed for MEDLINE]
Comment on:
Activated protein C: beyond 28 days.
Manocha S, Walley KR.
Publication Types:
PMID: 15640656 [PubMed - indexed for MEDLINE]
Comment on:
Bringing order to chaos.
Diringer MN.
Publication Types:
PMID: 15640654 [PubMed - indexed for MEDLINE]
Comment on:
Therapy of ventilator-associated pneumonia: what more can we do to use less antibiotics?
Niederman MS.
Publication Types:
PMID: 15640653 [PubMed - indexed for MEDLINE]
Comment on:
Afelimomab-another therapeutic option in sepsis therapy?
Grass G, Neugebauer EA.
Publication Types:
- Comment
- Editorial
- Meta-Analysis
- Review
- Review, Tutorial
PMID: 15640652 [PubMed - indexed for MEDLINE]
Comment in:
Absolutely no hope? Some ambiguity of futility of care in devastating acute stroke.
Wijdicks EF, Rabinstein AA.
Neurological-Neurosurgical Intensive Care Unit, Saint Marys, Mayo Clinic College of Medicine, Rochester, MN 55905, USA. wijde@mayo.edu
OBJECTIVE: Devastating stroke can produce irreversible brain damage of massive proportions. In those patients, continuation of aggressive medical or surgical care may be futile and may unnecessarily prolong the suffering of families. Therefore, it is essential for clinicians to be aware of key clinical and radiologic features predictive of poor outcome. There has not been a critical review of the data used to make decisions of withdrawal of care in patients with severe strokes. DATA SOURCE: Literature review. DATA SYNTHESIS: Although in many instances the studies that validate these prognosticators represent class III or class IV evidence, there are several clinico-radiologic profiles that have consistently been predictive of mortality or dependency after cerebrovascular catastrophes. CONCLUSIONS: Inconclusiveness remains in the determination of futility of care after major stroke. However, predictors of dismal outcome after several types of stroke have been identified and are relevant information in regard to withdrawal of care.
Publication Types:
PMID: 15640651 [PubMed - indexed for MEDLINE]
Comment in:
Validation of the Canadian clinical practice guidelines for nutrition support in mechanically ventilated, critically ill adult patients: results of a prospective observational study.
Heyland DK, Dhaliwal R, Day A, Jain M, Drover J.
Department of Medicine, Queen's University, Kingston, Ontario.
OBJECTIVE: Recently, evidence-based clinical practice guidelines for the provision of nutrition support in the critical care setting have been developed. To validate these guidelines, we hypothesized that intensive care units whose practice, on average, was more consistent with the guidelines would have greater success in providing enteral nutrition. DESIGN: Prospective observational study. SETTING: Fifty-nine intensive care units across Canada. PATIENTS: Consecutive cohort of mechanically ventilated patients. INTERVENTIONS: In May 2003, participating intensive care units recorded nutrition support practices on a consecutive cohort of mechanically ventilated patients who stayed for a minimum of 72 hrs. Sites enrolled an average of 10.8 (range, 4-18) patients for a total of 638. Patients were observed for an average of 10.7 days. MEASUREMENTS AND MAIN RESULTS: We examined the association between five recommendations from the clinical practice guidelines most directly related to the provision of nutrition support (use of parenteral nutrition, feeding protocol, early enteral nutrition, small bowel feedings, and motility agents) and adequacy of enteral nutrition. We defined adequacy of enteral nutrition as the percent of prescribed calories that patients actually received. Across sites, the average adequacy of enteral nutrition over the observed stay in intensive care unit ranged from 1.8% to 76.6% (average 43.0%). Intensive care units with a greater than median utilization of parenteral nutrition (>17.5% patient days) had a much lower adequacy of enteral nutrition (32.9 vs. 52.7%, p < .0001). Intensive care units that used a feeding protocol tended to have a higher adequacy of enteral nutrition than those that did not (44.9 vs. 38.5%, p = .03). Intensive care units that initiated enteral nutrition on >50% of their patients within the first 48 hrs had a higher adequacy of enteral nutrition than those that did not (48.1 vs. 34.4%, p < .0001). Intensive care units that had a >50% utilization of motility agents and/or any small bowel feedings in patients with high gastric residuals tended to have a higher adequacy of enteral nutrition than those intensive care units that did not (45.6 vs. 39.2%, p = .04, and 48.4 vs. 41.8%, p = .16, respectively). CONCLUSIONS: Intensive care units that were more consistent with the Canadian clinical practice guidelines were more likely to successfully feed patients via enteral nutrition. Adoption of the Canadian clinical practice guidelines should lead to improved nutrition support practice in intensive care units. This may translate into better outcomes for critically ill patients receiving nutrition support.
Publication Types:
PMID: 15640639 [PubMed - indexed for MEDLINE]
Comment in:
De-escalation therapy in ventilator-associated pneumonia.
Rello J, Vidaur L, Sandiumenge A, Rodriguez A, Gualis B, Boque C, Diaz E.
Critical Care Department, Joan XXIII University Hospital, University Rovira i Virgili, Tarragona, Spain.
OBJECTIVE: To evaluate de-escalation of antibiotic therapy in patients with ventilator-associated pneumonia. DESIGN: Prospective observational study during a 43-month period. SETTING: Medical-surgical intensive care unit. PATIENTS: One hundred and fifteen patients admitted to the intensive care unit with clinical diagnosis of ventilator-associated pneumonia. All the episodes of ventilator-associated pneumonia received initial broad-spectrum coverage followed by reevaluation according to clinical response and microbiology. Quantitative cultures obtained by bronchoscopic examination or tracheal aspirates were used to modify therapy. INTERVENTIONS:: None. MEASUREMENTS AND MAIN RESULTS: One hundred and twenty-one episodes of ventilator-associated pneumonia were diagnosed. Change of therapy was documented in 56.2%, including de-escalation (the most frequent cause) in 31.4% (increasing to 38% if isolates were sensitive). Overall intensive care unit mortality rate was 32.2%. Inappropriate antibiotic therapy was identified in 9% of cases and was associated with 14.4% excess intensive care unit mortality. Quantitative tracheal aspirates and bronchoscopic samples (58 protected specimen brush and three bronchoalveolar lavage) were associated with 32.7% and 29.5% intensive care unit mortality and 29.3% and 34.4% de-escalation rate. De-escalation was lower (p < .05) in the presence of nonfermenting Gram-negative bacillus (2.7% vs. 49.3%) and in the presence of late-onset pneumonia (12.5% vs. 40.7%). When the pathogen remained unknown, half of the patients died and de-escalation was not performed. CONCLUSION: De-escalation was the most important cause of antibiotic modification, being more feasible in early-onset pneumonia and less frequent in the presence of nonfermenting Gram-negative bacillus. The impact of quantitative tracheal aspirates or bronchoscopic techniques was comparable in terms of mortality.
PMID: 15640629 [PubMed - indexed for MEDLINE]
Comment in:
Efficacy and safety of the monoclonal anti-tumor necrosis factor antibody F(ab')2 fragment afelimomab in patients with severe sepsis and elevated interleukin-6 levels.
Panacek EA, Marshall JC, Albertson TE, Johnson DH, Johnson S, MacArthur RD, Miller M, Barchuk WT, Fischkoff S, Kaul M, Teoh L, Van Meter L, Daum L, Lemeshow S, Hicklin G, Doig C; Monoclonal Anti-TNF: a Randomized Controlled Sepsis Study Investigators.
Department of Medicine, University of California-Davis Medical Center, Sacramento, CA, USA.
OBJECTIVE: To evaluate whether administration of afelimomab, an anti-tumor necrosis factor F(ab')2 monoclonal antibody fragment, would reduce 28-day all-cause mortality in patients with severe sepsis and elevated serum levels of IL-6. DESIGN: Prospective, randomized, double-blind, placebo-controlled, multiple-center, phase III clinical trial. SETTING: One hundred fifty-seven intensive care units in the United States and Canada. PATIENTS: Subjects were 2,634 patients with severe sepsis secondary to documented infection, of whom 998 had elevated interleukin-6 levels. INTERVENTIONS: Patients were stratified into two groups by means of a rapid qualitative interleukin-6 test kit designed to identify patients with serum interleukin-6 levels above (test positive) or below (test negative) approximately 1000 pg/mL. Of the 2,634 patients, 998 were stratified into the test-positive group, 1,636 into the test-negative group. They were then randomly assigned 1:1 to receive afelimomab 1 mg/kg or placebo for 3 days and were followed for 28 days. The a priori population for efficacy analysis was the group of patients with elevated baseline interleukin-6 levels as defined by a positive rapid interleukin-6 test result. MEASUREMENTS AND MAIN RESULTS: In the group of patients with elevated interleukin-6 levels, the mortality rate was 243 of 510 (47.6%) in the placebo group and 213 of 488 (43.6%) in the afelimomab group. Using a logistic regression analysis, treatment with afelimomab was associated with an adjusted reduction in the risk of death of 5.8% (p = .041) and a corresponding reduction of relative risk of death of 11.9%. Mortality rates for the placebo and afelimomab groups in the interleukin-6 test negative population were 234 of 819 (28.6%) and 208 of 817 (25.5%), respectively. In the overall population of interleukin-6 test positive and negative patients, the placebo and afelimomab mortality rates were 477 of 1,329 (35.9%)and 421 of 1,305 (32.2%), respectively. Afelimomab resulted in a significant reduction in tumor necrosis factor and interleukin-6 levels and a more rapid improvement in organ failure scores compared with placebo. The safety profile of afelimomab was similar to that of placebo. CONCLUSIONS: Afelimomab is safe, biologically active, and well tolerated in patients with severe sepsis, reduces 28-day all-cause mortality, and attenuates the severity of organ dysfunction in patients with elevated interleukin-6 levels.
Publication Types:
- Clinical Trial
- Clinical Trial, Phase III
- Multicenter Study
- Randomized Controlled Trial
PMID: 15640628 [PubMed - indexed for MEDLINE]
-
How do I avoid being sued?
Ashley RC.
Legal Counsel, Critical Care Nurse, 101 Columbia, Aliso Viejo, CA 92656, USA.
PMID: 15646092 [PubMed - indexed for MEDLINE]
Protection of hepatocyte mitochondrial ultrastructure and function by strict blood glucose control with insulin in critically ill patients.
Vanhorebeek I, De Vos R, Mesotten D, Wouters PJ, De Wolf-Peeters C, Van den Berghe G.
Departments of Intensive Care Medicine, Catholic University of Leuven, B-3000 Leuven, Belgium.
BACKGROUND: Maintenance of normoglycaemia by use of insulin reduces morbidity and mortality of patients in surgical intensive care. Studies on mitochondrial function in critical illness or diabetes suggest that effects of intensive insulin therapy on mitochondrial integrity contribute to the clinical benefits. METHODS: Enzyme activities of the respiratory-chain complexes and oxidative-stress-sensitive glyceraldehyde-3-phosphate dehydrogenase (GAPDH) were measured by spectrophotometry in 36 snap-frozen samples of liver and skeletal muscle obtained after death from patients who had been randomly assigned intensive (normoglycaemia) or conventional (hyperglycaemia) insulin therapy and who were similar in terms of admission diagnoses and causes of death. Mitochondrial ultrastructure was examined by electron microscopy in a random subgroup (n=20). FINDINGS: In the liver, hypertrophic mitochondria with an increased number of abnormal and irregular cristae and reduced matrix electron density were observed in seven of nine conventionally treated patients. Only one of 11 patients given intensive insulin treatment had these morphological abnormalities (p=0.005). The effect on ultrastructure was associated with higher activities of respiratory-chain complex I (median 1.53 [IQR 1.14-3.01] vs 0.81 [0.54-1.43] U/g liver; p=0.008) and complex IV (1.69 [1.40-1.97] vs 1.16 [0.97-1.40] U/g; p=0.008) in the intensive group than in the conventional group. There was no detectable difference in GAPDH activity. In skeletal muscle, mitochondrial ultrastructure and function were not affected by intensive insulin therapy. INTERPRETATION: Strict glycaemic control with intensive insulin therapy prevented or reversed ultrastructural and functional abnormalities of hepatocyte mitochondria. The lack of effect on skeletal-muscle mitochondria suggests a direct effect of glucose toxicity and glucose control, rather than of insulin, as the likely explanation. RELEVANCE TO PRACTICE: Maintenance or restoration of mitochondrial function and cellular energetics is another therapeutic target, in addition to optimisation of cardiac output, systemic oxygen delivery, and regional blood flow, that might improve outcome for critically ill patients. Our findings could help to explain the mechanism underlying the reduction in mortality found when normoglycaemia was maintained with insulin, and further support use of intensive insulin therapy in this setting.
PMID: 15639679 [PubMed - indexed for MEDLINE]
-
A review of the efficacy and safety of opioid analgesics post-craniotomy.
Roberts G.
Department of Anaesthetics, Neath-Port Talbot Hospital, Bro-Morgannwg NHS Trust, South Wales, UK. gemma.roberts@bromor-tr.wales.nhs.uk
--Codeine phosphate is the most commonly used analgesic post-craniotomy. --It is argued, in this paper, that codeine phosphate is an unpredictable pro-drug that does not equate to a safe and effective method of providing analgesia post-craniotomy. --Lack of evidence supporting tramadol's usage and concerns over its interactions and side effects mean its use cannot be advocated. --The traditional justification for withholding morphine in post-craniotomy pain appears to be largely based on anecdotal evidence. --Raising awareness among critical care nurses of the pharmacological properties of the analgesics used is imperative, if post-craniotomy pain is to be adequately treated. --There is an explicit challenge to the neurosurgical community to re-evaluate their pain-management strategies in the post-craniotomy patient.
Publication Types:
PMID: 15575637 [PubMed - indexed for MEDLINE]
-
Ms. B and legal competence: interprofessional collaboration and nurse autonomy.
Goodman B.
Faculty of Health and Social Work, University of Plymouth, Pool, Cornwall, UK. b.goodman-1@plymouth.ac.uk
--Ms. B's wish for withdrawal of treatment was refused. --The nurses' role and autonomy in the decision-making is unclear. --Historically, tensions have existed in the doctor-nurse relationship. --Interprofessional collaboration is encouraged in order to facilitate team working. --Evidence is lacking that this is working and suggests continuing problems. --Legal and ethical education needs emphasizing in order to ensure respect for patient autonomy.
Publication Types:
- Legal Cases
- Review
- Review, Tutorial
PMID: 15575636 [PubMed - indexed for MEDLINE]
-
Sepsis strategies: an ICU package?
Ruffell AJ.
ITU, Colchester General Hospital, Colchester. Alison.Ruffell@essexrivers.nhs.uk
--Mortality of patients with severe sepsis remains at unacceptable levels and recent new strategies are not being widely embraced. --Five strategies are discussed within this article [low tidal volumes in acute lung injury/acute respiratory distress syndrome, early goal-directed therapy, drotrecogin alfa (activated), moderate dose corticosteroids and tight control of blood glucose]. --The critical care nurse plays a leading role in the detection, monitoring and treatment of patients with severe sepsis. --The role of the critical care nurse within the multidisciplinary team is explored. --Education, combination of strategies and the use of protocols are discussed.
Publication Types:
PMID: 15575634 [PubMed - indexed for MEDLINE]
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