UNLABELLED: DIAMOND: multicenter, 24-week, randomized trial investigating the effect of different once-daily, prolonged-release tacrolimus dosing regimens on renal function after de novo liver transplantation. Arm 1: prolonged-release tacrolimus (initial dose 0.2mg/kg/day); Arm 2: prolonged-release tacrolimus (0.15-0.175mg/kg/day) plus basiliximab; Arm 3: prolonged-release tacrolimus (0.2mg/kg/day delayed until Day 5) plus basiliximab. All patients received MMF plus a bolus of corticosteroid (no maintenance steroids). PRIMARY ENDPOINT: eGFR (MDRD4) at Week 24. Secondary endpoints: composite efficacy failure, BCAR and AEs. Baseline characteristics were comparable. Tacrolimus trough levels were readily achieved posttransplant; initially lower in Arm 2 versus 1 with delayed initiation in Arm 3. eGFR (MDRD4) was higher in Arms 2 and 3 versus 1 (p = 0.001, p = 0.047). Kaplan-Meier estimates of composite efficacy failure-free survival were 72.0%, 77.6%, 73.9% in Arms 1-3. BCAR incidence was significantly lower in Arm 2 versus 1 and 3 (p = 0.016, p = 0.039). AEs were comparable. Prolonged-release tacrolimus (0.15-0.175mg/kg/day) immediately posttransplant plus basiliximab and MMF (without maintenance corticosteroids) was associated with lower tacrolimus exposure, and significantly reduced renal function impairment and BCAR incidence versus prolonged-release tacrolimus (0.2mg/kg/day) administered immediately posttransplant. Delayed higher-dose prolonged-release tacrolimus initiation significantly reduced renal function impairment compared with immediate posttransplant administration, but BCAR incidence was comparable.

• MeSH
• hodnoty glomerulární filtrace MeSH
• imunosupresiva terapeutické užití   MeSH
• játra fyziologie   MeSH
• lidé středního věku MeSH
• lidé MeSH
• následné studie MeSH
• nemoci jater patofyziologie   chirurgie   MeSH
• pooperační komplikace MeSH
• přežívání štěpu fyziologie   MeSH
• prognóza MeSH
• rejekce štěpu farmakoterapie   patologie   MeSH
• rizikové faktory MeSH
• takrolimus terapeutické užití   MeSH
• transplantace jater * MeSH
• vyšetření funkce ledvin MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky, fáze III MeSH
• multicentrická studie MeSH
• randomizované kontrolované studie 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

• MeSH
• imunosupresivní léčba metody   MeSH
• management nemoci MeSH
• rejekce štěpu účinky léků   MeSH
• transplantace jater trendy   MeSH
• Geografické názvy
• Německo MeSH