Der Anaesthesist
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Multicenter Study Comparative Study
[Time in care of trauma patients in the air rescue service: implications for disposition?].
Time plays a crucial role in treating multiple traumatized patients and delays in management worsen the prognosis. Furthermore, current studies show that trauma patients profit from primary delivery to a trauma center. Therefore, the goal of physician-staffed ground and air rescue services in Germany is to treat these patients as quickly as possible and deliver them to a suitable trauma center. The aim of the present study was to investigate prehospital treatment times for the air rescue team in terms of disposition and efficiency when a ground rescue team was already present at the scene. ⋯ The treatment times for the helicopter were several minutes shorter when a physician-staffed ground rescue team had already arrived at the emergency site. However, it must be assumed that the total prehospital time is significantly longer for such missions. These results directly affect the disposition at the emergency dispatch center and indicate that when air rescue is required to transport a patient to hospital, the helicopter should be alerted at an early stage. In such settings, it is likely that initiating the operation in this way would improve the prognosis of severely injured patients and save costs.
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Randomized Controlled Trial Multicenter Study
Levobupivacaine for epidural anaesthesia and postoperative analgesia in hip surgery: a multi-center efficacy and safety equivalence study with bupivacaine and ropivacaine.
The aim of this randomized, single blind phase IIIb study was to evaluate the efficacy of 0.5% levobupivacaine versus 0.5% bupivacaine and 0.75% ropivacaine administered as epidural anesthesia and 0.125% levobupivacaine versus 0.125% bupivacaine and 0.2% ropivacaine for postoperative analgesia. The study was designed to test the equivalence of the overall profile of levobupivacaine against bupivacaine and ropivacaine. In addition, parameters of clinical safety were assessed. ⋯ The efficacy of epidural levobupivacaine for hip surgery and postoperative analgesia is equivalent and shows a comparable clinical profile to bupivacaine and 50-60% higher concentrated ropivacaine. The results of this equivalence study confirm suggestions derived from previous comparative studies.
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Randomized Controlled Trial Multicenter Study
[Vasopressin for therapy of persistent traumatic hemorrhagic shock: The VITRIS.at study].
While fluid management is established in controlled hemorrhagic shock, its use in uncontrolled hemorrhagic shock is being controversially discussed, because it may worsen bleeding. In the irreversible phase of hemorrhagic shock that was unresponsive to volume replacement, airway management and catecholamines, vasopressin was beneficial due to an increase in arterial blood pressure, shift of blood away from a subdiaphragmatic bleeding site towards the heart and brain and decrease of fluid resuscitation requirements. The purpose of this multicenter, randomized, controlled, international trial is to assess the effects of vasopressin (10 IU IV) vs. saline placebo IV (up to 3 injections at least 5 min apart) in patients with prehospital traumatic hemorrhagic shock that persists despite standard shock treatment. ⋯ The time window for randomization will close after 30 min of shock treatment. Exclusion criteria are terminal illness, no intravenous access, age <18 years, injury >60 min before randomization, cardiac arrest before randomization, presence of a do-not-resuscitate order, untreated tension pneumothorax, untreated cardiac tamponade, or known pregnancy. Primary study end-point is the hospital admission rate, secondary end-points are hemodynamic variables, fluid resuscitation requirements and hospital discharge rate.
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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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Multicenter Study Comparative Study
[Aprotinin in cardiac surgery: more risks than usefulness?].
Antifibrinolytic therapy with the serine protease inhibitor Aprotinin or the lysine analogues epsilon-aminocapronic acid or tranexamic acid is a therapeutic measure to reduce perioperative blood loss during cardiac surgery. In an international, prospective, non-randomised phase 4 observation study, Mangano et al. investigated the effectiveness and side-effects of Aprotinin, epsilon-aminocapronic acid and tranexamic acid in comparison to no antifibrinolytic therapy in a total of 4,374 patients who underwent cardiac surgery with extracorporeal circulation. In the opinion of Mangano et al. the results of this study question the safety and effectiveness of Aprotinin for reduction of perioperative blood loss by cardiac surgery patients. Despite a critical review of the study and results reported by Mangano et al., the authors of the present paper come to the conclusion that, in view of the availability of more reasonably priced alternatives in Germany, it appears to be sensible to give preference to tranexamic acid instead of aprotinin.