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      Assessment of hemodynamic efficacy and safety of 6% hydroxyethylstarch 130/0.4 vs. 0.9% NaCl fluid replacement in patients with severe sepsis: The CRYSTMAS study

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          Abstract

          Introduction

          Inadequate initial treatment and delayed hemodynamic stabilization (HDS) may be associated with increased risk of death in severe sepsis patients.

          Methods

          In order to compare the hemodynamic efficacy and safety of 6% HES 130/0.4 and NaCl 0.9% for HDS in patients with severe sepsis, we designed a prospective, multicenter, active-controlled, double-blind, randomized study in intensive care units.

          Results

          174 out of 196 patients reached HDS (88 and 86 patients for HES and NaCl, respectively). Significantly less HES was used to reach HDS vs. NaCl (1,379 ±886 ml in the HES group and 1,709 ±1,164 ml in the NaCl group (mean difference = -331± 1,033, 95% CI -640 to -21, P = 0.0185). Time to reach HDS was 11.8 10.1 hours vs. 14.3 ±11.1 hours for HES and NaCl, respectively. Total quantity of study drug infused over four consecutive days, ICU and hospital LOS, and area under the curve of SOFA score were comparable. Acute renal failure occurred in 24 (24.5%) and 19 (20%) patients for HES and NaCl, respectively ( P = 0.454). There was no difference between AKIN and RIFLE criteria among groups and no difference in mortality, coagulation, or pruritus up to 90 days after treatment initiation.

          Conclusion

          Significantly less volume was required to achieve HDS for HES vs. NaCl in the initial phase of fluid resuscitation in severe sepsis patients without any difference for adverse events in both groups.

          ClinicalTrials.gov

          NCT00464204

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          Most cited references25

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          The Surviving Sepsis Campaign: results of an international guideline-based performance improvement program targeting severe sepsis

          Objective The Surviving Sepsis Campaign (SSC or “the Campaign”) developed guidelines for management of severe sepsis and septic shock. A performance improvement initiative targeted changing clinical behavior (process improvement) via bundles based on key SSC guideline recommendations on process improvement and patient outcomes. Design and setting A multifaceted intervention to facilitate compliance with selected guideline recommendations in the ICU, ED, and wards of individual hospitals and regional hospital networks was implemented voluntarily in the US, Europe, and South America. Elements of the guidelines were “bundled” into two sets of targets to be completed within 6 h and within 24 h. An analysis was conducted on data submitted from January 2005 through March 2008. Main results Data from 15,022 subjects at 165 sites were analyzed to determine the compliance with bundle targets and association with hospital mortality. Compliance with the entire resuscitation bundle increased linearly from 10.9% in the first site quarter to 31.3% by the end of 2 years (P < 0.0001). Compliance with the entire management bundle started at 18.4% in the first quarter and increased to 36.1% by the end of 2 years (P = 0.008). Compliance with all bundle elements increased significantly, except for inspiratory plateau pressure, which was high at baseline. Unadjusted hospital mortality decreased from 37 to 30.8% over 2 years (P = 0.001). The adjusted odds ratio for mortality improved the longer a site was in the Campaign, resulting in an adjusted absolute drop of 0.8% per quarter and 5.4% over 2 years (95% CI, 2.5–8.4%). Conclusions The Campaign was associated with sustained, continuous quality improvement in sepsis care. Although not necessarily cause and effect, a reduction in reported hospital mortality rates was associated with participation. The implications of this study may serve as an impetus for similar improvement efforts. Electronic supplementary material The online version of this article (doi:10.1007/s00134-009-1738-3) contains supplementary material, which is available to authorized users.
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            A comparison of the RIFLE and AKIN criteria for acute kidney injury in critically ill patients.

            The Acute Dialysis Quality Initiative Group has published a consensus definition/classification system for acute kidney injury (AKI) termed the RIFLE criteria. The Acute Kidney Injury Network (AKIN) group has recently proposed modifications to this system. It is currently unknown whether there are advantages between these criteria. We interrogated the Australian New Zealand Intensive Care Society (ANZICS) Adult Patient Database (APD) for all adult admissions to 57 ICUs from 1 January 2000 to 31 December 2005. We compared the performance of the RIFLE and AKIN criteria for diagnosis and classification of AKI and for robustness of hospital mortality. We included 120 123 critically ill patients, of which 27.8% had a primary diagnosis of sepsis. We found only small differences (<1%) in the number of patients classified as having some degree of kidney injury using either the AKIN or RIFLE definition or classification systems. AKIN slightly increased the number of patients classified as Stage I injury (category R in RIFLE) (from 16.2 to 18.1%) but decreased the number of patients classified as having Stage II injury (category I in RIFLE) (13.6% versus 10.1%). The area under the ROC curve for hospital mortality was 0.66 for RIFLE and 0.67 for AKIN in all patients and it was 0.65 for both in septic patients. Compared to the RIFLE criteria, the AKIN criteria do not materially improve the sensitivity, robustness and predictive ability of the definition and classification of AKI in the first 24 h after admission to ICU.
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              Effects of hydroxyethylstarch and gelatin on renal function in severe sepsis: a multicentre randomised study.

              Hydroxyethylstarch used for volume restoration in brain-dead kidney donors has been associated with impaired kidney function in the transplant recipients. We undertook a multicentre randomised study to assess the frequency of acute renal failure (ARF) in patients with severe sepsis or septic shock treated with hydroxyethylstarch or gelatin. Adults with severe sepsis or septic shock were enrolled prospectively in three intensive-care units in France. They were randomly assigned 6% hydroxyethylstarch (200 kDa, 0.60-0.66 substitution) or 3% fluid-modified gelatin. The primary endpoint was ARF (a two-fold increase in serum creatinine from baseline or need for renal replacement therapy). Analyses were by intention to treat. 129 patients were enrolled over 18 months. Severity of illness and serum creatinine (median 143 [IQR 88-203] vs 114 [91-175] micromol/L) were similar at baseline in the hydroxyethylstarch and gelatin groups. The frequencies of ARF (27/65 [42%] vs 15/64 [23%], p=0.028) and oliguria (35/62 [56%] vs 23/63 [37%], p=0.025) and the peak serum creatinine concentration (225 [130-339] vs 169 [106-273] micromol/L, p=0.04) were significantly higher in the hydroxyethylstarch group than in the gelatin group. In a multivariate analysis, risk factors for acute renal failure included mechanical ventilation (odds ratio 4.02 [95% CI 1.37-11.8], p=0.013) and use of hydroxyethylstarch (2.57 [1.13-5.83], p=0.026). The use of this preparation of hydroxyethylstarch as a plasma-volume expander is an independent risk factor for ARF in patients with severe sepsis or septic shock.
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                Author and article information

                Journal
                Crit Care
                Crit Care
                Critical Care
                BioMed Central
                1364-8535
                1466-609X
                2012
                24 May 2012
                : 16
                : 3
                : R94
                Affiliations
                [1 ]Réanimation médicale, Assistance Publique - Hôpitaux de Paris, Hôpital Saint-Antoine, 184 rue du Faubourg Saint Antoine, Paris, F-75012, France
                [2 ]UPMC Université Paris 06, 4 Place Jussieu, Paris, 75005, France
                [3 ]Inserm, Unité de Recherche en Épidémiologie Systèmes d'Information et Modélisation (U707), Paris, F-75012, France
                [4 ]Réanimation Médicale, Hôpital Civil de Strasbourg, Place de l'Hôpital, 67091, Strasbourg, France
                [5 ]Réanimation Polyvalente, Hôpital de la Source, 1Rue Porte Madeleine, Orléans, 45032, France
                [6 ]Réanimation Polyvalente, Hôpital Saint-Joseph, 185 Rue Raymond Losserand, Paris, 75014, France
                [7 ]Université Paris Descartes, 12 Rue de L'École de Médecine, Paris, 75006, France
                [8 ]Réanimation Polyvalente, Centre Hospitalier de Metz, 1 Place Philippe de Vigneulles, Metz cedex, 57038, France
                [9 ]Réanimation Médicale, Hôpital Sud, Avenue René Laënnec-Salouël, Amiens, 80054, France
                [10 ]Réanimation, CH Meaux, 6-8 Rue Saint-Fiacre, Meaux, 77104, France
                [11 ]Réanimation et Maladies Infectieuses, Site de Belfort, CH de Belfort-Montbeliard, 14 Rue de Mulhouse, Belfort, 90016, France
                [12 ]Klinik für Anästhesiologie und Intensivmedizin, Universitätsklinikum, Hoppe-Seyler-Straße 3, Tübingen, 72076, Germany
                [13 ]Klinik und Poliklinik für Anästhesiologie und Operative Intensivmedizin der Westf, Wilhelms-Universität, Albert-Schweitzer-Str. 33, Münster, 48149, Germany
                Article
                cc11358
                10.1186/cc11358
                3580640
                22624531
                06279b34-85e3-44d6-bc2a-2da8fbce4c3e
                Copyright ©2012 Guidet et al.; licensee BioMed Central Ltd.

                This is an open access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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                Research

                Emergency medicine & Trauma
                Emergency medicine & Trauma

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