Der Anaesthesist
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Randomized Controlled Trial Multicenter Study
[The design of the VISEP trial. Critical appraisal].
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. ⋯ 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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Coagulopathy after trauma is a major cause for uncontrolled hemorrhage in trauma victims. Approximately 40% of trauma related deaths are attributed to or caused by exsanguination. Therefore the prevention of coagulopathy is regarded as the leading cause of avoidable death in these patients. ⋯ To overcome this coagulopahty-related bleeding an empiric therapy is often instituted by replacing blood components. However, the use of transfusion of red blood cells has been shown to be associated with post-injury infection and multiple organ failure. In the management of mass bleeding it is therefore crucial to have a clear strategy to prevent coagulopathy and to minimize the need for blood transfusion.
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Sleep is an essential part of life with many important roles which include immunologic, cognitive and muscular functions. Of the working population 20% report sleep disturbances and in critically ill patients an incidence of more than 50% has been shown. However, sleep disturbances in the intensive care unit (ICU) population have not been investigated in detail. ⋯ The rate of nosocomial infections, cognitive function and respiratory muscle function should be considered in these studies as well. This will help to answer the question, whether it is useful to monitor sleep in ICU patients as a parameter to indicate therapeutical success and short-term quality of life. Follow-up needs to be long enough to detect adverse effects of withdrawal symptoms after termination of analgesia and sedation or delirium.
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Levosimendan is a calcium sensitizer that is currently in the focus of intensive care medicine because it may be superior to standard inotropic agents in the treatment of acute myocardial insufficiency. The effects of levosimendan mainly depend on three predominant mechanisms: 1) positive inotropic effect by increasing the sensitivity of cardiac myofilaments to calcium ions, 2) vasodilatory effect by stimulation of adenosine triphosphate-sensitive potassium channels and 3) inhibition of phosphodiesterase-III. In a large number of experimental and clinical studies further possible indications for levosimendan have been described, e.g. cardioprotection during ischemia, cardiogenic shock, septic myocardial insufficiency and pulmonary hypertension. This review article critically summarizes the current scientific and clinical knowledge about levosimendan, its pharmacologic characteristics, mechanisms of action as well as indications and potential risks.
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In patients with severe hypothermia and cardiac arrest, active rewarming is recommended by extracorporeal circulation with cardiopulmonary bypass. The current guidelines for resuscitation of the European Resuscitation Council now include the recommendation regarding patients with hypothermia remaining comatose after initial resuscitation to accomplish an active rewarming only up to a temperature of 32-34 degrees C and to maintain a mild hypothermia for 12-24 h. We report the case of a 2-year-old boy who suffered from severe hypothermia after falling into ice-cold water. ⋯ Resuscitation led to restoration of spontaneous circulation. The patient was rewarmed by extracorporeal circulation with cardiopulmonary bypass to 33 degrees C then mild hypothermia was maintained for a further 12 h. On the third day after the accident the patient was extubated and after a further 9 days was discharged without any sequelae.