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1 SEVERE SEPSIS SEPTIC SHOCK > 3.0 G/DL Albumin Replacement in Patients with Severe Sepsis or Septic Shock N Engl J Med 2014; 370: PGY 5 J HOSPITALIST network Journal club
2 ADL /68mmHg 110/min /min SpO2 93 (RA) 6
3 2 TP 4.2 g/dl Alb 2.1 g/dl 4
4 CLINICAL QUESTION Alb Alb Septic shock Alb
5 EBM 5STEP STEP1 (PICO) STEP2 STEP3 STEP4 STEP5 STEP1 4
6 EBM 5STEP STEP1 (PICO) STEP2 STEP3 STEP4 STEP5 STEP1 4
7 STEP1 P Severe sepsis Septic shock I C O
8 EBM 5STEP STEP1 (PICO) STEP2 STEP3 STEP4 STEP5 STEP1 4
9 STEP2 PubMed Severe sepsis Septic shock Albumin concentration
10 ORIGINAL ARTICLE Albumin Replacement in Patients with Severe Sepsis or Septic Shock Pietro Caironi, M.D., Gianni Tognoni, M.D., Serge Masson, Ph.D., Roberto Fumagalli, M.D., Antonio Pesenti, M.D., Marilena Romero, Ph.D., Caterina Fanizza, M.Stat., Luisa Caspani, M.D., Stefano Faenza, M.D., Giacomo Grasselli, M.D., Gaetano Iapichino, M.D., Massimo Antonelli, M.D., Vieri Parrini, M.D., Gilberto Fiore, M.D., Roberto Latini, M.D., and Luciano Gattinoni, M.D. for the ALBIOS Study Investigators N Engl J Med 2014; 370: April 10, 2014 DOI: /NEJMoa Abstract Article References Citing Articles (52) Letters BACKGROUND Although previous studies have suggested the potential advantages of albumin administration in patients with severe sepsis, its efficacy MEDIA IN THIS ARTICLE FIGURE 1
11 EBM 5STEP STEP1 (PICO) STEP2 STEP3 STEP4 STEP5 STEP1 4
12 - - Mol Pharmacol 1975;11: J Biol Chem 1961;236:PC5. Clin Sci (Lond) 1998;95: Proc Natl Acad Sci USA 1992;89: J Appl Physiol 1976;40:762-7.
13 - Critical illness 4 - Severe sepsis N Engl J Med. 2004; 350: (SAFE study) - Critical illness Alb 3.0 g/dl Crit Care Med. 2006; 34:
14 PATIENT: INCLUSION 100 ICU 1 SIRS 2 SOFA score respiratory score>1 hematologic score>1 hepatic score>1 cardiovascular score equal to 1 3 or4 renal score>1
15 SOFA SCORE THE SEQUENTIAL ORGAN FAILURE ASSESSMENT SCORE
16 PATIENT: EXCLUSION 18 Severe sepsis or septic shock (New York Heart Association class of 3 or 4) Inclusion criteria 24
17 INTERVENTION Day28 ICU 20 + Alb 3.0 g/dl
18 COMPARISON Day28 ICU
19 OUTCOME Primary outcome 28 Secondary outcome 90 ICU Tertiary outcome AKI
20 PICO P ICU 18 Severe Sepsis I Day28 ICU 20 + Alb 3.0 g/dl C Day28 ICU O 28
21 P < 0.05 power 80% 28 45% ARR 7.5% 1350
22
23 - (concealment) -
24 Base-line Table 1. Characteristics of the Patients at Baseline.* Characteristic Age yr Albumin Group (N = 903) Crystalloid Group (N = 907) Median Interquartile range Female sex no. (%) 360 (39.9) 357 (39.4) Body-mass index 27±6 27±6 Reason for ICU admission no. (%) Medical 511 (56.6) 518 (57.1) Elective surgery 69 (7.6) 58 (6.4) Emergency surgery 323 (35.8) 331 (36.5) Preexisting condition no. (%) Liver disease 13 (1.4) 14 (1.5) COPD 113 (12.5) 108 (11.9) Chronic renal failure 44 (4.9) 32 (3.5) Immunodeficiency 115 (12.7) 128 (14.1) Congestive or ischemic heart disease 149 (16.5) 165 (18.2) SAPS II score Median Interquartile range
25 Base-line Table 1. (Continued.) ScvO2 Characteristic Physiological variable Albumin Group (N = 903) Crystalloid Group (N = 907) Heart rate beats/min 105±22 106±20 Mean arterial pressure mm Hg 74±16 73±15 Central venous pressure mm Hg 10.0± ±4.7 Urine output ml/hr Median Interquartile range Lactate mmol/liter Median Interquartile range Serum albumin g/liter 24.1± ±6.2 Hemoglobin g/dl 10.9± ±2.0 Central venous oxygen saturation % SOFA score Median Interquartile range Median 8 8 Interquartile range Organ dysfunction no. (%)** 1 organ 188 (20.8) 208 (22.9) 2 organs 361 (40.0) 303 (33.4) 3 organs 236 (26.1) 248 (27.3) 4 organs 89 (9.9) 115 (12.7) 5 organs 29 (3.2) 33 (3.6) Shock no. (%) 565 (62.6) 570 (62.8) Mechanical ventilation no. (%) 709 (78.5) 737 (81.3) Fluid administration in previous 24 hr no. (%) Albumin 153 (16.9) 176 (19.4) Synthetic colloids 452 (50.1) 479 (52.8)
26 Open labeling
27 98.3 vs vs 1.6 Intention to treat(itt) ITT Figure S1 910 Were assigned to receive Albumin 289 Underwent randomization within 6 hours 621 Underwent randomization between 6 and 24 hours 7 Were excluded 5 Were randomized twice 2 Withdrew consent for the use of their data 5 Were treated as Crystalloids 19 Discontinued trial fluid 2 Underwent randomization without inclusion criteria 6 Were withdrawn owing to violation of exclusion criteria 8 Were withdrawn owing to the occurence of exclusion criteria during the trial 2 Were withdrawn for medical reasons 1 Withdrew consent for receiving trial fluid 8 (0.9%) Were lost to follow-up 7 (0.8%) Were lost to follow-up 1818 Patients underwent randomization 908 Were assigned to receive Crystalloids 903 Were included in the analysis 907 Were included in the analysis 895 (99.1%) Were included in the analysis at 28 day 290 Underwent randomization within 6 hours 1 Was excluded 1 Was randomized twice 618 Underwent randomization between 6 and 24 hours 23 Discontinued trial fluid 6 Underwent randomization without inclusion criteria 6 Were withdrawn owing to violation of exclusion criteria 6 Were withdrawn owing to the occurence of exclusion criteria during the trial 4 Were withdrawn for medical reasons 1 Withdrew consent for receiving trial fluid 900 (99.2% Were included in the analysis at 28 day 7 (0.8%) Were lost to follow-up 7 (0.8%) Were lost to follow-up 888 (98.3%) Were included in the analysis at 90 day 893 (98.5%) Were included in the analysis at 90 day
28 0 A B Serum Albumin (g/liter) No. at Risk Albumin Crystalloids P< Study Day Albumin balance was computed from the time of randomization to day 1, which averaged 16 hours in the Day Crystalloids two Net Fluid Balance (ml) study groups. The horizontal line in the boxes indicates the median, the top and bottom of the box the interquartile range, and I bars the 5th and 95th per- 1 (p 2000 centile range. The P value is for the between-group < 0.001) Albumin Crystalloids Serum Alb No. at Risk Albumin Crystalloids P< Study Day B Figure 1. Serum Albumin Levels through Day 28 and Net Fluid 5000 Balance through Day 7. Panel A shows the serum albumin concentration through day in patients receiving albumin and crystalloids or crystalloids alone. Day 0 was defined as the 3000 time of randomization. Data are medians, with I bars indicating 2000 interquartile ranges. The P value is for the between-group comparison performed with the use of a two-factor 1000 analysis of variance for repeated measurements to test time (29 days for serum albumin, including day 0 0) and group effects. Panel B shows the net fluid balance through day 7 for patients receiving 1000 albumin and crystalloids or crystalloids alone. The daily net 2000 fluid balance was calculated as the difference between the total P<0.001 amount of administered fluid (including 20% 3000albumin; crystalloids; other blood products, such as packed red cells, fresh-frozen plasma, or platelets; and other fluids) and the total Study amount Dayof No. excreted at Riskfluid each day (including urinary output and Albumin other fluid losses, such 840 as fluids 789 potentially removed 639 Crystalloids with continuous renal-replacement therapy, fluids lost 635 as feces, aspirated gastric content, drainage fluids, and insensible perspiration). For day 1, the net fluid Net Fluid Balance (ml) secondary outcomes were assessed in patients who had septic shock and those who did not have septic shock at the time of enrollment. Heterogeneity of treatment effects among subgroups was assessed with the use of the test for a common relative risk. SAS software, version 9.2 (SAS Institute), was used for all the analyses. comparison performed with the use of the two-factor analysis of variance for repeated measurements to test time (7 days) and group effects Albumin Crystalloids Albumin Crystalloids surements to including day net fluid balan albumin and c daily net fluid between the t cluding 20% a ucts, such as platelets; and excreted fluid other fluid los with continuo as feces, aspir and insensible balance was c tion to day 1, study groups. cates the med interquartile r centile range. comparison p analysis of var time (7 days) ly assigned to loid solution alone (908) f patient enrol the interval the clinical cr ization: 6 ho versus more t of 8 patients (2 patients in drawal of co and 1 in the domization e Appendix). After follo were available the albumin
29 Table 2. Outcomes. 28 Underpower Outcome Albumin Group Crystalloid Group Relative Risk (95% CI) P Value Primary outcome: death at 28 days no./total no. (%) 285/895 (31.8) 288/900 (32.0) 1.00 ( ) 0.94 Secondary outcomes Death at 90 days no./total no. (%) 365/888 (41.1) 389/893 (43.6) 0.94 ( ) 0.29 New organ failures no./total no. (%)* 0.99 None 372/836 (44.5) 383/841 (45.5) 1 organ 283/836 (33.9) 287/841 (34.1) 2 organs 130/836 (15.6) 123/841 (14.6) 3 organs 40/836 (4.8) 36/841 (4.3) 4 organs 10/836 (1.2) 11/841 (1.3) 5 organs 1/836 (0.1) 1/841 (0.1) SOFA score 0.23 Median Interquartile range SOFA subscore Cardiovascular 0.03 Median Interquartile range Respiratory 0.63 Median Interquartile range Renal 0.15 Median Interquartile range Coagulation 0.04 Median Interquartile range Liver 0.02 Median Interquartile range Length of stay days In ICU 0.42 Median 9 9 Interquartile range In hospital 0.65 Median Interquartile range
30 RRR ARR NNT
31 Probability of Survival SECONDARY/TERTIARY OUTCOME Albumin Crystalloids (41.1 vs 43.6 p = 0.29) No. at Risk Albumin Crystalloids P= Days since Randomization Figure 2. Probability of Survival from Randomization through Day 90. The graph shows the Kaplan Meier estimates for the probability of survival among patients receiving albumin and crystalloids and among those receiving crystalloids alone. The P value was calculated with the use of the log-rank test.
32 SECONDARY/TERTIARY OUTCOME SOFA subscore (1.20 vs 1.42 p = 0.03) (0.64 vs 0.50 p = 0.04) (0.28 vs 0.20 P = 0.02) SOFA subscore (3 vs 4 p = 0.007) Secondary/Tertiary outcome ICU AKI
33 OTHERS Septic shock 90 (43.6 vs 49.9 p = 0.03) 6 MAP 7 MAP
34 STEP3 2 Open labeling 20% 3.0 g/dl Severe sepsis Septic shock 90 Septic shock 20
35 EBM 5STEP STEP1 (PICO) STEP2 STEP3 STEP4 STEP5 STEP1 4
36 STEP4 - Inclusion criteiria Exclusion criteria - Baseline characteristics -
37 STEP4 - Primary outcome - Septic shock 90 Post hoc subgroup 3.0 g/dl
38 EBM 5STEP STEP1 (PICO) STEP2 STEP3 STEP4 STEP5 STEP1 4
39 STEP5 STEP1 4 STEP1 - Severe sepsis Septic shock STEP2 - PubMed STEP3 - JAMA user s guide STEP4-3.0 g/dl
40 20% 3.0 g/dl Severe sepsis Septic shock g/dl Septic shock 90
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