Inhaled nitric oxide: clinical evidence for use in adults
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1 Inhaled nitric oxide: clinical evidence for use in adults Neill Adhikari Critical Care Medicine Sunnybrook Health Sciences Centre and University of Toronto 31 October 2014
2 Conflict of interest Ikaria provided data for 3 trials included in a metaanalysis No other support
3 Objectives Review data from randomized trials of inhaled NO, primarily in ARDS Consider whether our practice should change
4 1998 Nobel Prize in Physiology or Medicine Robert Furchgott Louis Ignarro Ferid Murad
5 N Engl J Med 1993;328: N=9
6 N Engl J Med 1993;328: N=9
7 N Engl J Med 1993;328: N=9
8 N Engl J Med 1993;328: N=7
9 Rapid clinical uptake Survey of ESICM members, % (196/310) used NO (95% reported ARDS as an indication) Survey of Ontario intensivists, % used NO sometimes or always 15% rarely 47% never Intensive Care Med 24:864-77, Crit Care Med 32:946-54
10 It s 2014 why is anyone still talking about NO?
11 This is one reason 250, ,000 total cost total patient-hours 2,500 2, ,000 1, ,000 1,000 50, /8 2008/9 2009/ / / / /14 Sunnybrook HSC, NO utilisation data Protocol 0
12 We re not the only ones who use NO Mayo Clinic: 7% of ARDS patients 10% of patients with LIS 3 H1N1 pandemic South Korea, 8% Europe, 12% Canada, 14% Crit Care Med 2010; 38(12 Suppl):377; Am J Respir Crit Care Med 2011; 183:A1643; Am J Respir Crit Care Med 2011; 183:A1698; Intensive Care Med 2010; 36(Suppl 2):S370 JAMA 2009; 302:
13 Arguments from the bedside Mayo Clinic: 7% of ARDS patients 10% of patients with LIS 3 H1N1 pandemic South Korea, 8% Europe, 12% Canada, 14% Absence of evidence Evidence of absence Don t talk to me about trials, my patient is very sick Crit Care Med 2010; 38(12 Suppl):377; Am J Respir Crit Care Med 2011; 183:A1643; Am J Respir Crit Care Med 2011; 183:A1698; Intensive Care Med 2010; 36(Suppl 2):S370 JAMA 2009; 302:
14 NO does not belong in this category Intubation or tracheostomy for airway obstruction Vasopressors for shock Early antibiotics for septic shock Insulin for DKA Epinephrine for anaphylaxis General anaesthesia for surgery Thus, using GRADE s definition of quality of evidence, the underlying quality of evidence to support these clinical interventions would be considered high although the evidence comes from observational studies or from unsystematic clinical observations. Journal of Clinical Epidemiology 64 (2011)
15 The data: meta-analysis of ARDS trials Old data! Mortality analysis: 9 trials, 1142 patients 2 other eligible trials (lost data; no contact) AECC criteria for ARDS (1 trial, ALI) Dose Fixed, 4 trials Lowest dose to improve oxygenation, 4 trials Randomized to different doses, 1 trial Duration Median 6.5 d (3.5-9)
16 P/F ratio: short term effect BMJ 2007;334:779
17 PA mean : short term effect BMJ 2007;334:779
18 No effect on mortality Crit Care Med 2014; 42:
19 Crit Care Med 2014; 42: No effect on mortality regardless of P/F ratio
20 Intensive Care Med 2010;36: Unlike proning
21 More AKI these trials represent 72% of randomized patients variable definitions (new RRT in Lundin, Payen) mechanism? BMJ 2007;334:779
22 Why was NO ineffective? (1) Oxygenation may be the wrong target ARDS network trial OSCILLATE Only 13-19% die from respiratory failure Benefit overwhelmed by injurious MV NO does not decrease VILI Chest 2005;128:525 32; ARRD 1985;132:485-9
23 Why was NO ineffective? (2) Accumulated toxicity over time Am J Respir Crit Care Med 2003;167:
24 84 patients undergoing lung transplantation Randomised to NO 20 ppm or nitrogen Started 10 mins after start of reperfusion, for 6 hours Median duration 10.5 hr (NO) vs. 9.6 hr (N 2 ) Criteria for unblinded NO Criteria for weaning Am J Respir Crit Care Med 2003;167:1483
25 Am J Respir Crit Care Med 2003;167:1483
26 Mitral valve surgery 28 patients with MS and pulmonary HTN for MV repair or replacement PA sys >60 mmhg and NYHA 2 Randomised, unblinded NO 10 ppm vs oxygen from end of CPB to up to 48 hours Via ETT and sealed mask after extubation Am J Cardiol 2011;107:
27 Mitral valve surgery NO Oxygen Am J Cardiol 2011;107:
28 LVAD implantation: physiology 20 ppm 20 ppm 11 patients with LVAD with PA mean >25 mmhg and CI <2.5 L/min/m 2 at end of CPB Ann Thorac Surg 1998;65:340 5
29 LVAD implantation: clinical 150 patients undergoing LVAD, with PVR 200 dyne/s/cm -5 Excluded: current or planned BiVAD or ECLS Randomised to NO 40 ppm or placebo starrting 5 mins before CPB wean, continued for up to 48 hrs Main outcome RV dysfunction J Heart Lung Transplant 2011;30:870 8
30 LVAD implantation: clinical NO Placebo p-value Open-label NO 21% 26% RV dysfunction 9.6% 15.6% day mortality 11.3% 11.4% day RVAD 5.6% 10.0% 0.47 RRT 14.1% 11.4% /35 crossovers BEFORE study defined criteria 15/18 from 1 centre J Heart Lung Transplant 2011;30:870 8
31 Possible responses to the data I don t believe the results Wrong patients Not enough patients Wrong design Wrong outcome Wrong treatment specifics I may still use NO sometimes, with appropriate humility about my convictions We need a total crackdown on NO prescription
32 Conclusions Physiologic mechanism of NO makes it an attractive therapy for several conditions RCTs support time-limited modest physiological effects RCTs in ARDS No effect on mortality regardless of hypoxemia Increased AKI mechanism unclear
33 Conclusions Use of NO is highly likely to continue In short term: limited harm and modest benefit more dramatic benefit in some Rule of rescue (clinicians thresholds differ) Temporising strategy Easy to administer Clinicians insensitive to costs at point of care Protocols may force early reassessment and stopping when physiologic goals not met
34 Conclusion: In summary, the discovery of and research on the many positive effects of ino has improved care of critically ill patients worldwide. It is a noble effort to continue on this path. Conflicts of interest: None.
35 thank you
36 What is NO? Atmospheric gas, 10 ppb to 1.5 ppm Rapidly inactivated when inhaled Airway epithelium: NO 2 reactive oxygen and nitrogen species Blood: Methemoglobin S-nitrosothiols vasodilation, platelet inhibitor
37 N Engl J Med 2005;353:
38 N Engl J Med 2005;353:
39 Effects of NO from RCTs Several multicentre RCTs found no mortality benefit Lundin, 1999, n=180 Payen, 1999, n=203 Taylor, 2004, n=385 Meta-analysis (2003) pooled data from 2 trials: RR 0.98 ( ) Additional data since previous review
40 Lundin et al, 1999 Intensive Care Med 25: centres in Europe Concealed, not blinded, 10/87 crossovers, ITT, complete f/u Stopped early (planned n=600) N=180 (responders randomized) Unilateral or bilateral infiltrates, P/F 165, PEEP 5, Paw 10 Lowest effective dose (mean 9 ppm, SD 8) Up to 30d (mean 9, SD 6)
41 Lundin et al, 1999 Intensive Care Med 25:911-9 NO n=93 control n=87 30d mortality 44.1% 40.2% 90d mortality Reversal ALI Severe resp fail p=0.04 New RRT or p=0.01 creat >300
42 Payen et al, 1999 Intensive Care Med 25(Suppl. 1):S centres in France Concealed, blinded, 19/105 crossovers to NO, ITT, complete f/u N=203 AECC criteria and LIS 2-3 after 24h optimisation 10 ppm Up to 28d (median 5d)
43 Payen et al, 1999 Intensive Care Med 25(Suppl. 1):S166 NO n=98 control n=105 28d mortality 49.0% 43.8% Hosp DC 90d New RRT
44 Taylor et al, 2004 JAMA 291: centres in USA Concealed, blinded, no crossovers, ITT, complete f/u Stopped early, planned N=516 N=385 AECC (ALI), P/F 250, PEEP 8 5 ppm Max 28 d (mean?)
45 Taylor et al, 2004 JAMA 291: NO n=192 control n=193 28d mortality 22.9% 20.2% VFD (28d) 10.7d 10.6d creat 6.2% 4.1%
46 Observations from these RCTs Slightly higher mortality in NO arm Slightly more renal dysfunction in NO arm The trial restricted to responders (Lundin) did not show benefit either
47 Objective: current meta-analysis evaluate the effects of NO in patients with established ALI and ARDS on pulmonary physiology (P a O 2 /F i O 2, OI, mean PA pressure) clinical outcomes (mortality and duration of ventilation) Adverse events
48 Methods Search of MEDLINE, EMBASE, CINAHL, CENTRAL (to Oct 2006) Proceedings ATS, SCCM, ESICM, Chest ( ) Bibliographies Contact with trial authors / experts
49 Methods Inclusion Parallel group RCTs NO used for treatment 80% ALI/ARDS or separately reported subgroup ALI/ARDS using authors definitions Adults and children (not neonates) Duplicate data abstraction
50 Methods Outcomes Mortality Duration MV, VFD Pulmonary physiology (days 1, 2, 3, 4) Adverse events
51 Methods Analysis Random-effects RCTs with <50% crossovers included in clinical outcomes analyses Data from multiple-dose groups combined Binary outcomes: RR Continuous outcomes: ratio of means, weighted mean difference Heterogeneity considered: dose, duration, ALI vs ARDS
52 OI: short term effect BMJ 2007;334:779
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