羟乙基淀粉 vs 晶体液治疗脓毒血症和感染性休克患者德国 sepnet visep 试验结果（英文）课件

1 3,170 ml HES3,170 ml HES 16,905 ml non-HES fluids16,905 ml non-HES fluids = = 1 1 5.35.3 VISEP Trial (HES vs. Ringers Lactate)VISEP Trial (HES vs. Ringers Lactate) - - Ratio of HES to non-HES fluids in the HES group (days 0-4)Ratio of HES to non-HES fluids in the HES group (days 0-4) - - 2 Hemodynamic effects 3 Mean arterial pressure 4 Central venous pressure 5 Central venous oxygen saturation 6 100 75 50 0 % of patients reaching composite goals 25 100200300400 hours 0500600 Ringerslactate n=150 HES n=146 p=0.024 VISEP Trial (HES vs. Ringers Lactate)VISEP Trial (HES vs. Ringers Lactate) - Results IV: Hemodynamic goals (CVP, MAP, ScvO- Results IV: Hemodynamic goals (CVP, MAP, ScvO 2 2 ) -) - 7 8 9 Effects on renal function 10 75.009.1874.1874.00 8.7173.44ScvO2 (%) 75.5013.63 76.2975.00 13.94 77.16MAP (mm Hg) 12.00 5.3012.1012.00 5.13 11.48CVP (mm Hg) 126.80 77.90141.99120.0085.72145.90Serum creatinine (mol/L) MedianSDMeanMedianSDMean HES n = 262 Ringers lactate n = 275 VISEP Trial (HES vs. Ringers Lactate) VISEP Trial (HES vs. Ringers Lactate) - Start of intervention - Start of intervention - 11 Diuresis Ringers Lactate HES Days 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 5000 4500 4000 3500 3000 2500 2000 1500 1000 500 0 ml 12 Creatinine 13 Mean SOFA Score7.53 Mean Ringers lactate n = 274 3.62 SD 6.75 Median 8.0 Mean HES n = 262 4.05 SD 7.29 Median 0.8 p 0.501.001.301.341.001.191.23CNS Hepatic Renal Coagulation Respiratory Cardiovascular SOFA-Subscores 0.52 0.84 0.55 2.48 1.90 Mean Ringers lactate 0.80 1.05 0.82 0.58 1.10 SD 0.11 0.42 0.11 2.57 1.76 Median 0.52 1.12 0.75 2.44 1.83 Mean HES 0.78 1.26 0.86 0.60 1.17 SD 0.09 0.67 0.46 2.50 1.80 Median 1.0 0.02 22 ml/kg/BW - HES 22 ml/kg/BW - 18 VISEP Trial (HES vs. Ringers Lactate)VISEP Trial (HES vs. Ringers Lactate) - HES 22 ml/kg/BW - HES 22 ml/kg/BW - 19 57.6%57.6% 30.9%30.9% 0%0% 25%25% 50%50% 75%75% 22.8%22.8% 33.0%33.0% 0%0% 25%25% 50%50% 75%75% 28-day mortality28-day mortality90-day mortality90-day mortality Mortality (%)Mortality (%) n=162n=162n=100n=100 HES HES 22 ml/kg BW/day *HES 22 ml/kg BW/day * n=162n=162n=99n=99 p=0.071p=0.071P 22 ml/kg BW/day 22 versus HES 22 ml/kg BW/day 20 Progression of mortality from Progression of mortality from 28 days to 90 days28 days to 90 days + 27%+ 27% + 15.3%+ 15.3% 0%0% 10%10% 20%20% 30%30% Absolute mortality Increase (%)Absolute mortality Increase (%) *on at least one study day + 9.8%+ 9.8% + 9.2%+ 9.2% HES HES 22 ml/kg BW/day* 22 ml/kg BW/day* HES HES ITT ITT CrystalloidCrystalloid + 6.8%+ 6.8% PROWESS Trial APC PROWESS Trial APC PROWESS Trial placeboPROWESS Trial placebo 21 100 75 50 25 0 Survival rate % 020406080100 days HES 22 ml/kg BW/day n=162 HES 22 ml/kg BW/day * n=99 * on at least one study day P 22 ml/kg/BW - 22 ml/kg/BW vs 22 ml/kg/BW - 22 0.003812.710.556.57.2 RBC nos 0.00059.57.89.8177.713.2 Days w/o vasopressor and inotropic support 0.011167.813.3197.315.7 Days w/o inotropic support 0.003157.712.0187.714.5 Days w/o vasopressor support 0.28003.21.802.81.49 Days w/o antibiotics 0.00054036.349.09135.966.5 Days w/o renal replacement therapy 22 ml/kg BW/day * n = 100 HES 22 ml/kg/BW - 22 ml/kg/BW vs 22 ml/kg/BW - 23 33.6%33.6% 30.9%30.9% 0%0% 25%25% 50%50% 75%75% 24.2%24.2% 22.8%22.8% 0%0% 25%25% 50%50% 75%75% 28-day mortality28-day mortality 90-day mortality90-day mortality Mortality (%)Mortality (%) n=256n=256n=162n=162 HESHESRingers lactateRingers lactate n=256n=256n=162n=162 p=0.747p=0.747p=0.562p=0.562 VISEP Trial (HES vs. Ringers Lactate)VISEP Trial (HES vs. Ringers Lactate) - Mortality HES - Mortality HES 24 hrs 10% HES 200/0.5 Results: n = 73 patients 34% experienced pruritus since discharge, 44% of these experienced severe, persistent pruritus unresolved by conventional treatment. Duration up to 1 year after ICU stay Cumulative dose ranged from 0 (n=3) to 27.35 litres (median 2 litres) infused over a median of 2 days (range 1-21 days) Occurrence of pruritus was signficantly related to volume of HES (p=0.003) 49 Foamy macrophage syndrome due to HES 6 % Auwerda et al, Ann Intern Med 2002 Patient: 38 yr old woman, plasmapheresis since 1997 because of IgG monoclonal gammopathy, performed initally with gelatin and albumin, since 1999 with HES 6% at a 1:1 ratio Clinical symptoms: Development of severe weight loss (BMI 17.6), sensory polyneuropathy of the legs, deteriorating eyesight, hepatosplenomegaly with ascites, normocytic anemia (Hb 7.1), thrombocytopenia (121,000), low serum creatinine (40 mol/L) and albumine (26g/L). MRI: vasculitis of the choroid plexus with hydrocephalus and pituitary stalk edema Histology: foamy macrophages in bone marrow, skin, duodenal mucosa, liver, peritoneum, dura mater and ascites Immunoelectron microscopy with anti-HES antibodies: massive tissue storage of HES, especially in macrophages 50 Foamy macrophage syndrome due to HES 6% Auwerda et al, Ann Intern Med 2002 Light microscopy: Bone marrow infiltration with CD68+ foamy macrophages (x200, left) Immunoelectron microscopy: Endothelial cells (A) and histiocytes (B). HES-antibody staining reveals typical HES+