Novel Sepsis Therapies
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1 RSEM-GSA 17 Novel Sepsis Therapies Khaled Ahmed Alghamdi, MD, ABEM, FACEP, FAAEM Consultant Emergency Medicine Deputy program director Medical Director of Emergency Medical Services King Faisal Specialist Hospital & Research Center Jeddah
2 Resuscitation : IV fluids Vasopressors Sepsis Modification Infection control Management of Sepsis
3 Novel Sepsis Therapies 1. Thrombomodulin in Sepsis induced DIC 2. Alkaline Phosphatase in Sepsis Associated Acute Kidney Injury 3. Selepressin Vs. Norepinephrine
4 Novel Sepsis Therapies coagulation Sepsis Organ failure Inflammatory response and endothelial injury
5 Thrombomodulin Thrombomodulin + protein C to support coagulation Microvasculature protection Interfere with complement pathway Anti-inflammatory property/ HMGB1 (cytokines) Complex mode of action
6 Thrombomodulin To determine the efficacy of TM in sepsis induced DIC in comparison to Heparin Retrospective, double-blind, randomized, controlled trial TM group n=40, Heparin group n=36 DIC resolution: 67.5% in TM, 55.6% in Heparin group Mortality rate: 3.7% in TM, 15% in Heparin group
7 Thrombomodulin
8 Thrombomodulin 1,784 patients from 42 ICU between Jan 2011 and Dec 2013 RhTM group = 645 and control group = 1139 Propensity score matching created 452 matched pairs In RhTM group: 1. Lower all cause mortality rate (OR, 0.757; 95 %, CI , p = 0.049) 2. Longer survival time (Hazard Ratio 0.7, 95% CI , P<0.05) 3. No frequent bleeding complications
9 Thrombomodulin To demonstrate the efficacy and safety of rhtm Multicenter, retrospective cohort study Pt. were stratified according to APACHE II and SOFA score 162 pt. with sepsis induced DIC, 68 pt. in rhtm group and 94 control group Survival benefit was observed with rhtm treatment in sepsis-induced DIC and high risk of death according to APACHE II and SOFA scores
10 Thrombomodulin Solid line= TM group, Doted line =placebo group
11 Thrombomodulin Safe intervention in septic patients Decrease mortality rate in patients with sepsis induced DIC Prolong survival time TM was approved in Japan for the treatment of DIC Bleeding complications are not more frequent Survival benefits observed in high and very high risk subsets according to APACHE II and SOFA scores
12 RSEM-GSA 17 Alkaline Phosphatase: treatment of AKI
13 Detoxify toxins by dephoshorylation Enzyme in the liver Deactivate ATP and form Adenosine: 1. Inhibit release of cytokines 2. Prevent tubular damage Alkaline Phosphatase
14 Alkaline Phosphatase To evaluate AP improves the renal function in sepsis induced AKI 36 pt. sever sepsis or septic shock 1 st outcome Cr clearance, requirement and duration of RRT 2 nd outcome changes in the circulating inflammatory markers
15 Alkaline Phosphatase
16 Alkaline Phosphatase Significant values in favor of 1ry outcome (p=0.02) Reduction in inflammatory markers Conclusion: alkaline phosphatase improves renal function in Sepsis induced AKI. This represented by 1. Improvement of endogenous CrCl 2. Decreased requirement and duration of RRT (dialysis) 3. Recommend use of recombinant human AP and larger study
17 Alkaline Phosphatase Randomized, double blind, placebocontrolled, dose finding study Minimum 290 pt. will be enrolled at 50 sites Treatment given in 24hrs of SA-AKI and within 96 hrs. of diagnosis of sepsis 1ry endpoint time-corrected CrCl curve d1-d7 2 nd is RRT requirement
18 Alkaline Phosphatase This is the first randomized controlled trial in SA-AKI with comparable standard of care Results will be used to conclude the efficacy of rhap in treatment of SA- AKI
19 In conclusion: Alkaline Phosphatase 1. rhap is a potential treatment option for critically ill patient with sepsis associated acute kidney injury 2. The use of rhap on healthy volunteers didn t raise any safety concerns 3. rhap reduces the requirement of RRT
20 RSEM-GSA 17 Selepressin vs. Norepinephrine
21 Selepressin Vasopressin derivative (cyclic nonpeptide) Selective V1a receptor agonist May have advantage over vasopressin Vasoconstrictive effect Prevent vascular leak
22 Selepressin Multicenter, Post hoc analysis of data of control group Excessive use of pressors can increase mortality and organ dysfunction Increase mortality RR=1.83 Shock RR=1.64 Metabolic acidosis RR=1.79 AKI RR= 1.49
23 Selepressin Randomized animal study Postpartum lung wet/dry weight ratio A late intervention B early intervention P<0.005 selepressin. C= control SEL= selepressin AVP= arginine vasopressin NE= norepinephrine
24 Use of V1a agonist in septic shock Selepressin Randomized, double blind, placebocontrolled multicenter trial Different doses of selepressin 1ry shock resolution and maintenance of MAP>60 mmhg +/- NE 2 nd fluid balance, organ failure and safety.
25 Selepressin
26 Selepressin
27 Selepressin Selepressin 2.5ng/kg/min replaced and lower NE requirement Selepressin moderates vascular permeability and protect against injury Prevent excessive use of NE which is associated with organ failure, metabolic acidosis, increased mortality
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