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Query: UMLS:C0036690 (sepsis)
 59,461 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

The survey transcript of the VISEP interventional trial "Prospective randomized multicenter study on the influence of colloid vs crystalloid volume resuscitation and of intensive vs conventional insulin therapy on outcome in patients with severe sepsis and septic shock" [Clinical trials.gov. identifier: NCT00135473; study start April 2003] comprises, according to the data of the year 2003, methodological shortcomings which challenge a priori the study design and thus the resolution of the purpose of the study, i.e., "determination of the influence of the studied volume and insulin interventions on morbidity and mortality of patients with severe sepsis and septic shock". The most important points of criticism are: 1. A volume therapy with exclusively crystalloids or colloids with the chosen colloid hyperoncotic, hyperchloremic HES solution (10% hydroxyethyl starch: 10% Hemohes) or the crystalloid solution with high lactate content (Sterofundin) is neither acceptable nor practicable, even if only due to exceeding the maximum dosage as recommended by the manufacturer. 2. The fact known since the year 2001 that high molecular weight, poorly biodegradable HES preparations can present an independent risk-factor for acute kidney failure in patients with sepsis or septic shock was ignored: the exclusion criterion of a serum-creatinine value of >320 micromol/l (>3.6 mg/dl) was doubled in relation to the manufacturer's specification. 3. The hyperoncotic colloid solution used (10% Hemohes) may only be employed for a brief period: it is highly hyperchloremic and causes extravascular hypohydration with consecutive reduction of renal excretion, which together with HES is a fatal combination. 4. The crystalloid solution used, i.e., Sterofundin, which contains 45 mmol/l lactate, is contraindicated with septic shock as it increases the patient's O2 consumption, hinders lactate diagnostics as a hypoxia marker by simultaneous lactate infusion, and through increased gluconeogenesis leads to hyperglycemia, at least with diabetics. 5. It is doubtful whether an intensified insulin therapy (Actrapid) can be successful if insulin is administered simultaneously with iatrogenic hyperglycemia as a result of lactate influx. Due to these flaws in the design of the VISEP trial, the only consequence can be that the results of the survey are unusable, especially with regard to the point "HES and kidney function". Thus, any further advance presentations and interpretations should be shelved in expectation of the authors' publication of all the data, in order to begin further discussions including the flaws in study design listed here.
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PMID:[The design of the VISEP trial. Critical appraisal]. 1719 28

The Scandinavian Starch for Severe Sepsis / Septic Shock (6S) trial showed that hydroxyethyl starch was harmful compared to Ringer's acetate in patients with severe sepsis when used according to clinical practice and in alignment with the recommendations by the manufactures and authorities. The different interpretation by Chapell and Jacob's rely on misreading of the trial publication and is not supported by the trial data. Several hypotheses may be made regarding less harmful ways of using HES in critically ill patients, but clinicians, guideline committee members and authorities need to acknowledge that such safer ways have not yet been identified.
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PMID:Debate on HES safety is important, but must be based on facts. 2432 77

We compared the effects of hypertonic saline 7.2%/6% hydroxyethyl starch (HSS-HES) and isotonic saline 0.9%/6% hydroxyethyl starch (ISS-HES) on ileal microcirculatory blood flow (MBF) at the initial phase of septic shock. Pigs were anesthetized and mechanically ventilated. Catheters were inserted into right atrium, pulmonary artery, carotid artery, and portal vein for hemodynamic measurements and for blood sampling. Ileal mucosal and muscularis MBF was continuously measured by laser Doppler flowmetry (LDF). Septic shock was obtained 240 min after induction of fecal peritonitis; then animals were randomized to receive 10 mL.kg(-1) during 10 min of either HSS-HES or ISS-HES. Systemic and microcirculatory blood flow as well as systemic metabolism were assessed. Fecal peritonitis promoted a hypodynamic septic shock, with significant reduction of mean arterial pressure (MAP) and cardiac index (CI). Ileal mucosal MBF (-34%) and ileal muscularis MBF (-54%) significantly diminished from baseline. Contrary to ISS-HES group, mucosal MBF significantly augmented after HSS-HES (+192% at min 150 post-shock) despite low blood pressure. There was weak correlation with CI (r(2)= 0.2, P=0.01) . Muscularis MBF didn't change. HSS-HES-treated animals had a significantly higher osmolarity and sodium concentration than ISS-HES group. Other variables did not change. Small-volume resuscitation with HSS-HES, but not ISS-HES, improved ileal microcirculatory impairment in experimental peritonitis model of septic shock even when MAP was low. This beneficial microcirculatory effect could be valuable in the management of early severe sepsis.
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PMID:Small-volume hypertonic saline/pentastarch improves ileal mucosal microcirculation in experimental peritonitis. 2447 Sep 29

The possibility of renal damage by hydroxyethyl starch has become the focus of intensive dispute based on the findings of published large trials. The aim of this narrative review is to analyze outcome reporting bias in the literature on volume resuscitation, focusing on selective outcome reporting in published randomized and observational trials with "modern" hydroxyethyl starch as therapeutic intervention. Three recent publications claimed to confirm renal safety of hydroxyethyl starch 130/0.4 for indications in severe sepsis, trauma, and critical illness, respectively. Selective outcome reporting was identified in these studies including underreporting of side effects and change of primary study outcomes. In conclusion, selective outcome reporting bias is identified in recent publications of clinical trials on volume resuscitation with HES.
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PMID:Reporting bias in trials of volume resuscitation with hydroxyethyl starch. 2459 76

Objectives The objective was to determine survival and changes in creatinine concentrations after administration of 6% tetrastarch (hydroxyethyl starch [HES] 130/0.4) vs crystalloids in critically ill cats. Methods The medical records were reviewed for cats admitted to the intensive care unit with at least two plasma creatinine measurements and initial concentrations not exceeding the upper reference interval. Cats were excluded if they had received HES prior to admission or if they had received fluid therapy for <24 h between initial and subsequent measurements. Changes in creatinine concentrations were evaluated as the percentage change from initial values to the maximum subsequent measurements. Cats receiving only crystalloids were assigned to the crystalloid group; cats receiving only HES or HES and crystalloids were assigned to the HES group. Results Ninety-three cats were included in the study (62 in the crystalloid group, 31 in the HES group). The total median cumulative HES dose was 94 ml/kg (range 26-422 ml/kg) and 24 ml/kg/day (range 16-42 ml/kg/day). No difference was detected between the groups for age, sex, body weight or mortality. The HES group had a significantly longer length of hospitalisation ( P = 0.012), lower albumin concentrations ( P <0.001), higher Acute Patient Physiologic and Laboratory Evaluation scores ( P = 0.037) and higher incidence of systemic inflammatory response syndrome ( P = 0.009) and sepsis ( P = 0.013). There was no significant difference in initial, maximum or maximum change in creatinine concentrations between the groups. Moreover, there was no significant difference in maximum change in creatinine concentrations in the subgroups of cats with systemic inflammatory response syndrome or sepsis. Conclusions and relevance In this population of cats, the administration of HES did not result in a significantly greater increase in creatinine from values measured on admission or higher mortality compared with administration of crystalloids. Further prospective studies are needed to assess both safety and efficacy of HES in cats before recommendations can be made.
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PMID:Effect of tetrastarch (hydroxyethyl starch 130/0.4) on plasma creatinine concentration in cats: a retrospective analysis (2010-2015). 2780 12


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