BACKGROUND: The prophylactic administration of tranexamic acid reduces blood loss during procedures at high risk of perioperative bleeding. Several studies in cardiac surgery and orthopedics confirmed this finding. The aim of this prospective, double-blind, randomized study is to evaluate the effect of tranexamic acid on peri-and postoperative blood loss and on the incidence and severity of complications. METHODS/DESIGN: Based on the results of our pilot study, we decided to conduct this prospective, double-blind, randomized trial to confirm the preliminary data. The primary endpoint is to analyze the effect of tranexamic acid on perioperative and postoperative blood loss (decrease in hemoglobin levels) in robotic-assisted radical prostatectomy. The additional endpoint is to analyze the effect of tranexamic acid on postoperative complications and confirm the safety of tranexamic acid in robotic-assisted radical prostatectomy. DISCUSSION: No study to date has tested the prophylactic administration of tranexamic acid at the beginning of robotic-assisted radical prostatectomy. This study is designed to answer the question of whether the administration of tranexamic acid might lower the blood loss after the procedure or increase the rate and severity of complications. TRIAL REGISTRATION: ClinicalTrials.gov NCT04319614. Registered on 25 March 2020.

• MeSH
• antifibrinolytika škodlivé účinky   MeSH
• dvojitá slepá metoda MeSH
• kyselina tranexamová * škodlivé účinky   MeSH
• lidé MeSH
• pilotní projekty MeSH
• pooperační krvácení etiologie   prevence a kontrola   MeSH
• prospektivní studie MeSH
• prostatektomie * metody   MeSH
• randomizované kontrolované studie jako téma MeSH
• roboticky asistované výkony * metody   MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• protokol klinické studie MeSH

BACKGROUND: Meropenem dosing for septic critically patients is difficult due to pathophysiological changes associated with sepsis as well as supportive symptomatic therapies. A prospective single-center study assessed whether fluid retention alters meropenem pharmacokinetics and the achievement of the pharmacokinetic/pharmacodynamic (PK/PD) targets for efficacy. METHODS: Twenty-five septic ICU patients (19 m, 6f) aged 32-86 years with the mean APACHE II score of 20.2 (range 11-33), suffering mainly from perioperative intra-abdominal or respiratory infections and septic shock (n = 18), were investigated over three days after the start of extended 3-h i.v. infusions of meropenem q8h. Urinary creatinine clearance (CLcr) and cumulative fluid balance (CFB) were measured daily. Plasma meropenem was measured, and Bayesian estimates of PK parameters were calculated. RESULTS: Eleven patients (9 with peritonitis) were classified as fluid overload (FO) based on a positive day 1 CFB of more than 10% body weight. Compared to NoFO patients (n = 14, 11 with pneumonia), the FO patients had a lower meropenem clearance (CLme 8.5 ± 3.2 vs 11.5 ± 3.5 L/h), higher volume of distribution (V1 14.9 ± 3.5 vs 13.5 ± 4.1 L) and longer half-life (t1/2 1.4 ± 0.63 vs 0.92 ± 0.54 h) (p < 0.05). Over three days, the CFB of the FO patients decreased (11.7 ± 3.3 vs 6.7 ± 4.3 L, p < 0.05) and the PK parameters reached the values comparable with NoFO patients (CLme 12.4 ± 3.8 vs 11.5 ± 2.0 L/h, V1 13.7 ± 2.0 vs 14.0 ± 5.1 L, t1/2 0.81 ± 0.23 vs 0.87 ± 0.40 h). The CLcr and Cockroft-Gault CLcr were stable in time and comparable. The correlation with CLme was weak to moderate (CLcr, day 3 CGCLcr) or absent (day 1 and 2 CGCLcr). Dosing with 2 g meropenem q8h ensured adequate concentrations to treat infections with sensitive pathogens (MIC 2 mg/L). The proportion of pre-dose concentrations exceeding the MIC 8 mg/L and the fraction time with a target-exceeding concentration were higher in the FO group (day 1-3 f Cmin > MIC: 67 vs 27%, p < 0.001; day 1%f T > MIC: 79 ± 17 vs 58 ± 17, p < 0.05). CONCLUSIONS: These findings emphasize the importance of TDM and a cautious approach to augmented maintenance dosing of meropenem to patients with FO infected with less susceptible pathogens, if guided by population covariate relationships between CLme and creatinine clearance.

• MeSH
• antibakteriální látky metabolismus   farmakokinetika   MeSH
• APACHE MeSH
• Bayesova věta MeSH
• dospělí MeSH
• farmakokinetika * MeSH
• jednotky intenzivní péče organizace a řízení   statistika a číselné údaje   MeSH
• kritický stav terapie   MeSH
• lidé středního věku MeSH
• lidé MeSH
• meropenem metabolismus   farmakokinetika   MeSH
• prospektivní studie MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• sepse farmakoterapie   patofyziologie   MeSH
• vodní a elektrolytová rovnováha účinky léků   MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• Geografické názvy
• Česká republika MeSH

BACKGROUND: This retrospective clinical study would like to objectively denote a quality of life of persons afflicted by an abdominal catastrophe and managed by an extensive surgery can be almost as well conformable as those of healthy people in a similar age group. METHODS: A set of eighteen patients who were successfully surgically treated and cured enjoyed a relatively good convalescence after their surgery and returned to a satisfactory standard of life from the point of view of organ function and psychosomatic state. Statistical analysis of the data collected over a period of 1 to 6 years after this complex therapy using special questionnaire for QOL assessment SF-36 was performed. RESULTS: Almost half of the patients evaluated their state similarly to the rest of the population of comparable age and general health status. The remainder of the patients declared significantly worse evaluations in the majority of the observed domains of the questionnaire. CONCLUSION: Therapy of these patients was and must be complex: it included preparation for surgery at a special metabolic internal site, careful diagnostics of the digestive tract state, suitable surgery and good quality care after the surgery.

• MeSH
• chirurgie trávicího traktu metody   MeSH
• dospělí MeSH
• kvalita života * MeSH
• lidé středního věku MeSH
• lidé MeSH
• průzkumy a dotazníky MeSH
• retrospektivní studie MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• střevní píštěle chirurgie   MeSH
• zákroky plastické chirurgie metody   MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• klinická studie MeSH