Bicarbonates pour l acidose : BICAR-ICU
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1 JAVA Créteil 1 décembre 2019 Bicarbonates pour l acidose : BICAR-ICU Samir JABER Department of Critical Care Medicine and Anesthesiology (DAR B) Saint Eloi University Hospital and Montpellier School of Medicine Clinical and experimental research unit = INSERM U Avenue Augustin Fliche; Montpellier. FRANCE
2 Disclosures Consultants with honorarium - Dräger - Fisher-Paykel - Xenios - Baxter
3 Background Severe Acidosis in ICU : - Frequent (15-40%) - Worse outcome - Mortality up to 60% - Sodium bicarbonate infusion to treat severe metabolic acidosis is controversial. Jung et al, Crit Care 2011
4 2011 ph < 7.20 Mortality = 57%
5 Severe Acidemia is bad! Persistent acidosis has been associated with poor prognosis 5 Jung et al, Crit Care 2011
6 Sodium bicarbonate infusion to treat severe metabolic acidosis is controversial. Good? Bad? Neutral?
7 «The effect of bicarbonate administration on hemodynamics and vasopressor requirements at lower ph, is unknown. «No studies have examined the effect of bicarbonate administration on outcomes» Dellinger et al; Intensive Care Med Feb: Rhodes A, Evans LE, Alhazzani W, et al. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: Intensive Care Med 2017;43(3):304 77
8 RCT? The lack of high-level evidence leaves ICU clinicians uncertain whether bicarbonate infusion is beneficial, ineffective, or indeed harmful
9 NCT LANCET 2018 Funding Support: This is an investigator-initiated trial funded by the French Ministry of Health (Programme Hospitalier de Recherche Clinique Inter Régional 2013) and the Societe Française d Anesthesie Réanimation (SFAR). The sponsor was Montpellier University Hospital. The funding bodies had no role in study design, data collection, analysis, or interpretation, or writing of the manuscript.
10 AIM OF THE STUDY To determine if Sodium Bicarbonate has an impact on the prognosis of severly acidotic patients in the ICU Hypothesis: Bicarbonate will decrease D-28 mortality, or The number of patients presenting at least one organ failure at D7 as defined by a SOFA > 2
11 SECONDARY ENDPOINTS 1. SOFA Score: D0, D1, D2, D5, D7 2. AKIN Score: D0, D1, D2, D5, D7 3. RRT : yes/no from D1 to D28 4. MV (either invasive or NIV): yes/no from D1 to D28 5. Vasopressors: yes/no from D1 to D28 6. Fluid loading: D0, D1, D2, D5 7. Acid-base analysis (ABG): 1. D0 to D2: every 8h 2. D3 to D5: every 24h 8. Electrolytes disturbances (including calcemia) 1. D0 to D2: every 8h 2. D3 to D5: every 24h 9. Nosocomial infections: up to D28 or ICU discharge 10. ICU free-days: up to D28 or ICU discharge 11. Hospital free-days: up to D28 or ICU discharge 12. Survival at D28: yes/no
12 DESIGN OF THE STUDY RCT Multicenter (n=26) Stratified, two-arm unblinded parallel-arms study Stratification Intention To Treat analysis (n=400)
13 INCLUSION CRITERIA Within 48h following ICU admission (4 criteria must be present): 1. ph PaCO2 45 mmhg 3. Bicarbonatemia 20 mmol/l 4. SOFA(total) 4 and/or lactatemia > 2mmol/l
14 NON INCLUSION CRITERIA 1. Bicarbonate loss (profuse diarrhoea, ileostomy>1000ml/24h, proven tubular acidosis) 2. Chronic Kidney failure needing RRT 3. Stage IV Chronic Kidney Insufficiency (Clairance <30ml/min) 4. Acidoketosis / Acids poisoning 5. Withdrawal of care / death in the next 48h 6. Tutelage 7. No health insurance 8. Pregnancy 9. Consent refusal
15 Group-0 N=200 = 0 Bicar N=400 patients - 2 Groups Electronic Randomisation 3 stratifications (/center Group-Bicar N=200 = Bicar 4.2% ml/30min 1. Sepsis upon inclusion: Yes No 2. Renal failure (AKIN): Age: < 65 yrs 65 yrs
16 ICU admission H0-H48: screening 4 criteria needed 1. ph 7.20 and 2. PaCO2 45 mmhg and 3. Bicarbonatemia 20 mmol/l and 4. SOFA 4 and/or Lactates > 2mmol/l Randomisation Sodium Bicarbonate 4.2% : 125 to 250 ml / 30min ph > 7.30 ABG H1 - H4 Sodium Bicarbonate maximum 1000ml/24h ABG H1 - H4 post Bicar ph 7.30 ph 7.30 Consider RRT Consider RRT ph > 7.30 No Bicar 1 test minimum 1 test minimum 0
17 942 Patients were assessed for eligibility 542 Were excluded 109 Had received already bicarbonate 87 Had moribund state 76 Had treatment limitation 69 Had chronic renal failure 47 Had immediate RRT indication 41 Had keto-acidosis 37 Had digestives losses 21 Were eligible but not enrolled 18 Were included in another clinical study 13 Had hyperkalemia with heart signs 13 Declined to participate 11 Were under guardianship protection 400 Underwent randomization 201 Were assigned to control arm 199 Were assigned to bicarbonate arm 7 Withdrew consent 4 Withdrew consent 194 Were included in 28-day follow-up and analysis 195 Were included in 28-day follow-up and analysis
18 Arterial ph level in patients in the control and in the bicarbonate arms at baseline and after enrolment (overall population)
19 Arterial bicarbonate level in patients in the control and in the bicarbonate arms at baseline and after enrolment (overall population).
20 PaCO 2 level in patients in the control and in the bicarbonate arms at baseline and after enrolment (overall population
21 Outcome Control Arm (N = 194) Bicarbonate Arm (N = 195) P value Primary outcome no. (%) Overall population (n=389) Composite outcome 138 (71) 128 (66) Day 28 mortality 104 (54) 87 (45) At least one organ failure at day 7 50 (46) 55 (43) Patients with AKIN 2-3 (n=182) Composite outcome 74/90 (82) 64/92 (70) Day 28 mortality 57/90 (63) 42/92 (46) At least one organ failure at day 7 74/90 (82) 61/92 (66) 0.014
22 A. Time to Death in Overall Patients D-28 Mortality Bicarbonate arm 45% Control arm 54% P-value = Control arm Bicarbonate arm
23 B Time to Death in Patients with pre-specified Acute Kidney Injury D-28 Mortality Bicarbonate arm 46% Control arm 63% P-value = Control arm Bicarbonate arm
24 C. Relative Risk of 28 day mortality among all the Patients and in the three prespecified strata Control arm Bicarbonate arm Absolute difference in % (95%CI) P-value P-value for heterogeneity
25 in Patients with pre-specified Acute Kidney Injury Renal-Replacement Therapy 73% 51%
26 Intensive Care Medicine (nov 2018) 1. No significant mortality effect in the overall population (n=1718) of Sodium Bicarbonate 2. Sodium Bicarbonate infusion was associated with improved survival outcome in septic patients with AKI 2 and ph < 7.2.
27 Take Home Message (from Bicar-ICU) 1. Bicarbonate did not significantly decrease day-28 mortality or the presence of at least one organ failure at day-7 in the overall population with severe metabolic acidosis (ph 7.20) 2. Bicarbonate infusion decreased the need for renalreplacement therapy (52 vs 35%, p<0,01) 3. In the a priori stratum of patients with acute kidney injury, infusion of bicarbonate resulted in fewer deaths by day-28 (63 vs 46%, p=0,017)
28 Thank you
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