26 Nov 08
Posted in rhAPC at 0:00 by Laci
By P-F Laterre, WL Macias, J Janes, MD Williams, DR Nelson, A RJ Girbes, J-F Dhainaut and E Abraham
Critical Care 2008;12:R117
We performed a study to determine whether an enrollment sequence effect noted in the PROWESS (recombinant human activated Protein C Worldwide Evaluation in Severe Sepsis) trial exists in the ADDRESS (Administration of Drotrecogin Alfa [Activated] [DrotAA] in Early Stage Severe Sepsis) trial.
Methods
We evaluated prospectively defined subgroups from two large phase 3 clinical trials: ADDRESS, which included 516 sites in 34 countries, and PROWESS, which included 164 sites in 11 countries. ADDRESS consisted of patients with severe sepsis at low risk of death not indicated for treatment with DrotAA. PROWESS consisted of patients with severe sepsis with one or more organ dysfunctions. DrotAA (24 μg/kg per hour) or placebo was infused for 96 hours.
Results
In ADDRESS and PROWESS, there was a statistically significant interaction between the DrotAA treatment effect and the sequence in which patients were enrolled. In both trials, higher mortality was associated with DrotAA use in the subgroup of patients enrolled first at study sites. Compared with placebo, PROWESS mortality was lower with DrotAA treatment for the second and subsequent patients enrolled, whereas in ADDRESS, mortality remained higher for the second patient enrolled but thereafter was lower for DrotAA-treated patients. Comparison of patients enrolled first with subsequent patients enrolled indicated that the characteristics of patients changed. Subsequently enrolled patients were treated earlier, were less likely to suffer nonserious bleeds (ADDRESS), and experienced fewer protocol violations (PROWESS).
Conclusions
Analyses suggest that an enrollment sequence effect was present in the ADDRESS and PROWESS trials. Analysis of this effect on outcomes suggests that it is most apparent in patients at lower risk of death. In PROWESS, this effect appeared to be associated with a reduction of the DrotAA treatment effect for the first patients enrolled at each site. In ADDRESS, this effect may have contributed to early termination of the study. The finding of an enrollment sequence effect in two separate trials suggests that trial designs, site selection and training, data collection and monitoring, and statistical analysis plans may need to be adjusted for these potentially confounding events.
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24 Nov 08
Posted in Monitoring, PA catheter at 0:00 by Laci
By GD Rubenfeld, E McNamara-Aslin, L Rubinson
JAMA. 2007;298:458-461
In this issue of JAMA, an investigation using a nationally representative administrative database reported a marked decline in the use of pulmonary artery (PA) catheters from 5.66 per 1000 medical admissions in 1993 to 1.99 per 1000 medical admissions in 2004. These significant declines in PA catheter utilization were most prominent for patients with myocardial infarction (81% decrease), but also were significant for surgical patients (63% decrease) and for patients with septicemia (54% decrease).
These national data are consistent with trends at our institution, an academic public hospital and level 1 trauma center with 75 intensive care unit (ICU) beds with a relatively low volume of patients with acute myocardial infarction. For example, from July 2002 to May 2003, the hospital billed patients for 871 PA catheters. Although the ICU census has increased, the use of PA catheters has declined to 262 catheters from July 2006 to May 2007. Recently, nurses and residents gathered around the bedside of the sole patient in the medical ICU with a PA catheter so they could actually observe one in use. If the demise of the PA catheter is more than a rumor, why has this occurred and what are the implications for clinical care and training?
Forty years have passed since the afternoon in 1967 when Jeremy Swan watched boats from a Santa Monica beach and conceived of a bedside procedure that would use cardiac output to sail a catheter into the pulmonary arteries. PA catheterization was initially used to assess patients with acute myocardial infarction, but use of this procedure spread rapidly to the operating department and from there to a broad range of patients in the ICU. The addition of mixed venous oximetry and cardiac output measurement to central venous and pulmonary arterial pressure monitoring provided clinicians with detailed feedback about physiological response to therapy. This information, coupled with clinical evaluation, allowed clinicians to titrate fluids, inotropes, vasopressors, and vasodilators to optimize oxygen delivery to tissues. Twenty years after its invention (in 1987), more than 2 million PA catheters had been sold worldwide annually. However, enthusiasm was not universal, and in the late 1980s concerns were raised about the unknown benefits of PA catheter–guided therapy in the face of potential risks from an invasive procedure.
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22 Nov 08
Posted in Glucose control at 0:00 by Laci
By RS Wiener, DC Wiener, RJ Larson
JAMA. 2008;300(8):933-944
The American Diabetes Association and Surviving Sepsis Campaign recommend tight glucose control in critically ill patients based largely on 1 trial that shows decreased mortality in a surgical intensive care unit. Because similar studies report conflicting results and tight glucose control can cause dangerous hypoglycemia, the data underlying this recommendation should be critically evaluated.
Objective
To evaluate benefits and risks of tight glucose control vs usual care in critically ill adult patients.
Data Sources
MEDLINE (1950-2008), the Cochrane Library, clinical trial registries, reference lists, and abstracts from conferences from both the American Thoracic Society (2001-2008) and the Society of Critical Care Medicine (2004-2008).
Study Selection
We searched for studies in any language in which adult intensive care patients were randomly assigned to tight vs usual glucose control. Of 1358 identified studies, 34 randomized trials (23 full publications, 9 abstracts, 2 unpublished studies) met inclusion criteria.
Data Extraction and Analysis
Two reviewers independently extracted information using a prespecified protocol and evaluated methodological quality with a standardized scale. Study investigators were contacted for missing details. We used both random- and fixed-effects models to estimate relative risks (RRs).
Results
Twenty-nine randomized controlled trials totaling 8432 patients contributed data for this meta-analysis. Hospital mortality did not differ between tight glucose control and usual care overall (21.6% vs 23.3%; RR, 0.93; 95% confidence interval [CI], 0.85-1.03). There was also no significant difference in mortality when stratified by glucose goal ([1] very tight: ≤110 mg/dL; 23% vs 25.2%; RR, 0.90; 95% CI, 0.77-1.04; or [2] moderately tight: <150 mg/dL; 17.3% vs 18.0%; RR, 0.99; 95% CI, 0.83-1.18) or intensive care unit setting ([1] surgical: 8.8% vs 10.8%; RR, 0.88; 95% CI, 0.63-1.22; [2] medical: 26.9% vs 29.7%; RR, 0.92; 95% CI, 0.82-1.04; or [3] medical-surgical: 26.1% vs 27.0%; RR, 0.95; 95% CI, 0.80-1.13). Tight glucose control was not associated with significantly decreased risk for new need for dialysis (11.2% vs 12.1%; RR, 0.96; 95% CI, 0.76-1.20), but was associated with significantly decreased risk of septicemia (10.9% vs 13.4%; RR, 0.76; 95% CI, 0.59-0.97), and significantly increased risk of hypoglycemia (glucose ≤40 mg/dL; 13.7% vs 2.5%; RR, 5.13; 95% CI, 4.09-6.43).
Conclusion
In critically ill adult patients, tight glucose control is not associated with significantly reduced hospital mortality but is associated with an increased risk of hypoglycemia.
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21 Nov 08
Posted in Procedure videos at 0:00 by Laci
By K Tegtmeyer, G Brady, S Lai, R Hodo and D Braner
NEJM 2008;358:e30
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This video will demonstrate arterial line placement in the radial artery using two of the many techniques available for arterial line placement, an over-the-wire technique and an over-the-needle technique. Placement of an arterial line is indicated for continuous monitoring of arterial pressure and direct arterial blood sampling. |
The radial pulse is palpated between the distal radius and the flexor carpi radialis tendon. Prior to line placement, perfusion of the extremity should be checked. For radial arterial catheters, an Allen test or a modified Allen test may be performed. While the value of the Allen test has . . . .
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