BACKGROUND: Hydroxyethyl starch (HES) solutions are used for volume therapy to treat hypovolemia due to acute blood loss and to maintain hemodynamic stability. This study was requested by the European Medicines Agency (EMA) to provide more evidence on the long-term safety and efficacy of HES solutions in the perioperative setting. METHODS: PHOENICS is a randomized, controlled, double-blind, multi-center, multinational phase IV (IIIb) study with two parallel groups to investigate non-inferiority regarding the safety of a 6% HES 130 solution (Volulyte 6%, Fresenius Kabi, Germany) compared with a crystalloid solution (Ionolyte, Fresenius Kabi, Germany) for infusion in patients with acute blood loss during elective abdominal surgery. A total of 2280 eligible patients (male and female patients willing to participate, with expected blood loss ≥ 500 ml, aged > 40 and ≤ 85 years, and ASA Physical status II-III) are randomly assigned to receive either HES or crystalloid solution for the treatment of hypovolemia due to surgery-induced acute blood loss in hospitals in up to 11 European countries. The dosing of investigational products (IP) is individualized to patients' volume needs and guided by a volume algorithm. Patients are treated with IP for maximally 24 h or until the maximum daily dose of 30 ml/kg body weight is reached. The primary endpoint is the treatment group mean difference in the change from the pre-operative baseline value in cystatin-C-based estimated glomerular filtration rate (eGFR), to the eGFR value calculated from the highest cystatin-C level measured during post-operative days 1-3. Further safety and efficacy parameters include, e.g., combined mortality/major post-operative complications until day 90, renal function, coagulation, inflammation, hemodynamic variables, hospital length of stay, major post-operative complications, and 28-day, 90-day, and 1-year mortality. DISCUSSION: The study will provide important information on the long-term safety and efficacy of HES 130/0.4 when administered according to the approved European product information. The results will be relevant for volume therapy of surgical patients. TRIAL REGISTRATION: EudraCT 2016-002162-30 . ClinicalTrials.gov NCT03278548.

• MeSH
• břicho * chirurgie   MeSH
• deriváty hydroxyethylového škrobu * škodlivé účinky   chemie   MeSH
• dvojitá slepá metoda MeSH
• elektrolyty MeSH
• lidé MeSH
• multicentrické studie jako téma MeSH
• náhražky plazmy škodlivé účinky   MeSH
• prospektivní studie MeSH
• randomizované kontrolované studie jako téma MeSH
• senioři nad 80 let MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• senioři nad 80 let MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• protokol klinické studie MeSH

• MeSH
• albuminy terapeutické užití   MeSH
• dextrany škodlivé účinky   terapeutické užití   MeSH
• intravenózní podání * MeSH
• koloidy * terapeutické užití   MeSH
• kongresy jako téma MeSH
• lidé MeSH
• náhražky plazmy * terapeutické užití   MeSH
• ošetřovatelská péče o pacienty v kritickém stavu metody   MeSH
• tekutinová terapie * metody   MeSH
• Check Tag
• lidé MeSH

Současné důkazy svědčí o tom, že kombinace profylaktického podání vazopresorů s aplikací HES před anestezií („preloading") či při zahájení anestezie („coloading") nebo s aplikací krystaloidů při zahájení anestezie („coloading") je nejlepší metodou prevence hypotenze u rodičky po zahájení subarachnoidální anestezie. Podání krystaloidů před anestezií („preloading") je klinicky neúčinné a nemělo by se již používat.

• MeSH
• císařský řez metody   MeSH
• dospělí MeSH
• hemodynamika fyziologie   MeSH
• isotonické roztoky terapeutické užití   MeSH
• koloidy terapeutické užití   MeSH
• lidé MeSH
• náhražky plazmy terapeutické užití   MeSH
• peroperační monitorování MeSH
• porodnická anestezie MeSH
• spinální anestezie MeSH
• těhotenství s dvojčaty MeSH
• těhotenství MeSH
• tekutinová terapie metody   MeSH
• Check Tag
• dospělí MeSH
• lidé MeSH
• těhotenství MeSH
• ženské pohlaví MeSH
• Publikační typ
• přehledy MeSH

The volume resuscitation is a pivotal problem during shock in extensively burnt patients. Significant changes in hemostasis originate simultaneously with development of burns shock. These processes have the principal influence on survival prognosis. Resulting from a precise analysis, the expected benefit of this project will be an introduction of a new standard algorithms to the therapy of burns shock .

Otázka objemové resuscitace je stěžejním problémem v řešení popáleninového šoku u rozsáhle popálených. S rozvojem popáleninového šoku dochází k podstatným změnám hemokoagulačních poměrů.Tyto dva děje mají zásadní vliv na prognózu přežití popálených. Řešení výzkumného úkolu má na základě přesnější diagnostické analýzy a vytvořením léčebných algoritmů významným způsobem přispět k optimalizaci léčebných postupů v průběhu popáleninového šoku.

• MeSH
• cévní rezistence MeSH
• hemodynamika MeSH
• koagulopatie MeSH
• minutový srdeční výdej MeSH
• náhražky plazmy MeSH
• popálení MeSH
• traumatický šok MeSH
• tromboelastografie MeSH

• Konspekt
• Patologie. Klinická medicína
• NLK Obory
• traumatologie
• anesteziologie a intenzivní lékařství
• popáleninová medicína
• NLK Publikační typ
• závěrečné zprávy o řešení grantu IGA MZ ČR

Fluid resuscitation in trauma patients with hemorrhagic shock is controversially discussed in the literature. The coincidence of brain injury complicates management of these patients. This article summarizes the current knowledge on nonblood component fluid resuscitation and choice of fluids in patients with multiple trauma. RECENT FINDINGS: Whereas current evidence suggests the efficacy of fluid therapy in hemorrhagic shock without active bleeding, experimental and clinical data demonstrate that aggressive volume challenge may be futile or even deleterious in the setting of uncontrolled hemorrhage. Large amounts of isotonic crystalloids may be associated with hypothermia, acidosis and inflammation. In patients with traumatic brain injury hypertonic solutions may positively influence inflammation and intracranial pressure without affecting neurologic outcome or mortality. SUMMARY: To date no large-scale clinical studies exist to either support or refute the use of nonblood component fluid resuscitation of hemorrhagic shock in trauma patients. The optimal choice of fluid remains to be determined, but existing evidence suggests avoiding crystalloids in favor of hypertonic solutions. The role of modern, iso-oncotic colloids in the treatment of hemorrhagic shock has not yet been sufficiently defined. In patients with concomitant brain injury, arterial hypotension must be avoided and infusion of hypotonic solutions is obsolete, whereas administration of hypertonic solutions may exert beneficial effects beyond hemodynamic stabilization.

• MeSH
• hemoragický šok farmakoterapie   patofyziologie   terapie   MeSH
• hypertonické roztoky terapeutické užití   MeSH
• isotonické roztoky terapeutické užití   MeSH
• koloidy terapeutické užití   MeSH
• lidé MeSH
• náhražky plazmy terapeutické užití   MeSH
• polytrauma patofyziologie   terapie   MeSH
• poranění mozku terapie   MeSH
• resuscitace metody   MeSH
• tekutinová terapie MeSH
• urgentní zdravotnické služby MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• přehledy MeSH

• MeSH
• hematologie MeSH
• krevní banky MeSH
• krevní náhražky MeSH
• krevní transfuze MeSH
• lidé MeSH
• náhražky plazmy MeSH
• nemocnice fakultní MeSH
• transfuze trombocytů MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• směrnice MeSH

OBJECTIVE: Hypovolemia has occurs frequently in sepsis. Due to pathologically increased permeability of the capillaries, the fluid leaks to the interstitium. An adequate fluid therapy is the corner stone to achieve circulatory stabilization and sufficient tissue perfusion; on the other hand, according to the data from the literature a tissue swelling is associated with a risk of deteriorated function of the tissues. The study aimed to examine the effect of a positive fluid balance on muscular metabolism. METHODS: The experimental study employed the model of sepsis in the domestical pig. Ten animals were randomly distributed into a control and a septic group. Sepsis was induced by intravenous administration of E. coli, followed by fluid resuscitation by crystaloids. Microdialysis samples were withdrawn at one-hour intervals for a period of 24 hours and values of lactate, pyruvate, glycerol, and glucose. RESULTS: Pearson's method revealed positive correlations between the lactate/pyruvate ratio and cumulative fluid balance in the septic group (R=0.292, p<0.001) and negative correlations in the control group (R=-0.279, p<0.05). In both groups, however, there was a gradual significant decrease in glycerol values. CONCLUSION: Fluid resuscitation results in positive fluid balance in both septic and control animals. This leads to circulatory stabilization of septic animals, but not a decrease in the anaerobic share of glycolysis. A positive fluid balance in control animals does not result in alteration of muscular aerobic glycolysis. Decreasing glycerol levels in both groups give evidence that a positive fluid balance does not exert a negative impact on cell metabolism.

• MeSH
• glycerol krev   MeSH
• hypovolemie terapie   MeSH
• infekce vyvolané Escherichia coli patologie   MeSH
• isotonické roztoky terapeutické užití   MeSH
• krevní glukóza metabolismus   MeSH
• kyselina mléčná krev   MeSH
• kyselina pyrohroznová krev   MeSH
• mikrodialýza MeSH
• náhražky plazmy terapeutické užití   MeSH
• prasata MeSH
• resuscitace MeSH
• sepse metabolismus   patologie   MeSH
• tekutinová terapie MeSH
• vodní a elektrolytová rovnováha fyziologie   MeSH
• zvířata MeSH
• Check Tag
• zvířata MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH

Hydroxyethyl starch 200 is associated with renal impairment in sepsis, but hydroxyethyl starch 130/0.4 and gelatin are considered to be less harmful. We hypothesized that fluid therapy with only crystalloids would decrease the incidence of acute kidney injury. DESIGN: Prospective sequential comparison during intensive care unit stay. SETTING: Surgical intensive care unit. PATIENTS: Patients with severe sepsis. INTERVENTIONS: Changes in standard fluid therapy, with predominantly 6% hydroxyethyl starch from January 2005 to June 2005, 4% gelatin from January 2006 to June 2006, and only crystalloids from September 2008 to June 2009. MEASUREMENTS AND MAIN RESULTS: Acute kidney injury was defined by the presence of at least one RIFLE class; 118 patients received hydroxyethyl starch, 87 patients received gelatin, 141 patients received only crystalloids. Baseline serum creatinine values were similar. Patients received median cumulative doses of 46 (interquartile range, 18-92) mL/kg hydroxyethyl starch and 43 (interquartile range, 18-76) mL/kg gelatin. Total median fluid amounts were 649 (interquartile range, 275-1098) mL/kg in the hydroxyethyl starch group, 525 (237-868) mL/kg in the gelatin group, and 355 (173-911) mL/kg in the crystalloid group. The difference was statistically significant for hydroxyethyl starch after adjustment for multiple testing. Mean daily fluid intake and fluid balance were higher on days 0 and 1 in the crystalloid group. Acute kidney injury occurred in 70% of patients receiving hydroxyethyl starch (adjusted p = .002) and in 68% of patients receiving gelatin (adjusted p = .025) vs. 47% patients receiving crystalloids. Need for renal replacement therapy tended to be higher in the hydroxyethyl starch group (34%; adjusted p = .086) and in the gelatin group (34%; adjusted p = .162) in comparison to the crystalloid group (20%). Intensive care unit and hospital mortality were similar in each group (hydroxyethyl starch: 35% and 43%; gelatin: 26% and 31%; crystalloids: 30% and 37%). CONCLUSION: Fluid resuscitation with only crystalloids was equally effective, resulted in a more positive fluid balance only on the first 2 days, and was associated with a lesser incidence of acute kidney injury.

• MeSH
• deriváty hydroxyethylového škrobu terapeutické užití   MeSH
• financování organizované MeSH
• incidence MeSH
• isotonické roztoky terapeutické užití   MeSH
• kohortové studie MeSH
• lidé středního věku MeSH
• lidé MeSH
• náhražky plazmy terapeutické užití   MeSH
• renální insuficience epidemiologie   chemicky indukované   prevence a kontrola   MeSH
• retrospektivní studie MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• sepse komplikace   terapie   MeSH
• tekutinová terapie MeSH
• želatina terapeutické užití   MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• srovnávací studie MeSH

INTRODUCTION: Pre-hospital induction of therapeutic mild hypothermia (TH) may reduce post-cardiac arrest brain injury in patients resuscitated from out-of-hospital cardiac arrest. Most often, it is induced by a rapid intravenous administration of as much as 30 ml/kg of cold crystalloids. We decided to assess the pre-hospital cooling effectivity of this approach by using a target dose of 15-20 ml/kg of 4°C cold normal saline in the setting of the physician-staffed Emergency Medical Service. The safety and impact on the clinical outcome have also been analyzed. METHODS: We performed a prospective observational study with a retrospective control group. A total of 40 patients were cooled by an intravenous administration of 15-20 ml/kg of 4°C cold normal saline during transport to the hospital (TH group). The pre-hospital decrease of tympanic temperature (TT) was analyzed as the primary endpoint. Patients in the control group did not undergo any pre-hospital cooling. RESULTS: In the TH group, administration of 12.6 ± 6.4 ml/kg of 4°C cold normal saline was followed by a pre-hospital decrease of TT of 1.4 ± 0.8°C in 42.8 ± 19.6 min (p < 0.001). The most effective cooling was associated with a transport time duration of 38-60 min and with an infusion of 17 ml/kg of cold saline. In the TH group, a trend toward a reduced need for catecholamines during transport was detected (35.0 vs. 52.5%, p = 0.115). There were no differences in demographic variables, comorbidities, parameters of the cardiopulmonary resuscitation and in other post-resuscitation characteristics. The coupling of pre-hospital cooling with subsequent in-hospital TH predicted a favorable neurological outcome at hospital discharge (OR 4.1, CI95% 1.1-18.2, p = 0.046). CONCLUSIONS: Pre-hospital induction of TH by the rapid intravenous administration of cold normal saline has been shown to be efficient even with a lower dose of coolant than reported in previous studies. This dose can be associated with a favorable impact on circulatory stability early after the return of spontaneous circulation and, when coupled with in-hospital continuation of cooling, can potentially improve the prognosis of patients. TRIAL REGISTRATION: ClinicalTrials (NCT): NCT00915421.

• MeSH
• časové faktory MeSH
• chlorid sodný aplikace a dávkování   MeSH
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• náhražky plazmy aplikace a dávkování   MeSH
• nízká teplota MeSH
• prospektivní studie MeSH
• retrospektivní studie MeSH
• senioři MeSH
• srdeční zástava diagnóza   terapie   MeSH
• terapeutická hypotermie metody   MeSH
• urgentní zdravotnické služby metody   MeSH
• výsledek terapie MeSH
• vztah mezi dávkou a účinkem léčiva MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky MeSH
• multicentrická studie MeSH
• práce podpořená grantem MeSH
• srovnávací studie MeSH

• MeSH
• hemostáza chirurgická MeSH
• kongresy jako téma MeSH
• krevní transfuze škodlivé účinky   MeSH
• krvácení při operaci prevence a kontrola   MeSH
• lidé MeSH
• náhražky plazmy klasifikace   MeSH
• Check Tag
• lidé MeSH