1. Welcome The Pediatric Guidelines from the Surviving Sepsis Campaign: Considerations for Care

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4. Stephen L. Davidow, MBA-HCM, APR
Manager, Quality Implementation Programs
Society of Critical Care Medicine
Mount Prospect, IL
Today’s webcast is funded by a generous grant
from the Gordon and Betty Moore Foundation

5. Welcome The Pediatric Guidelines from the Surviving Sepsis Campaign: Considerations for Care

6. Save the Date! The Next Surviving Sepsis Campaign Webcast
October 15, 2013, 1 pm CT
Topic: The Surviving Sepsis Campaign
as a Model for Mentoring
Faculty:
Ryan O’Gowan, MBA, PA-C, FCCM, St. Vincent Hospital
Marie Mullen, MD, University of Massachusetts
Emanuel P. Rivers, MD, MPH, Henry Ford Health System

7. Margaret M. Parker, MD, FCCM
Professor of Pediatrics, Anesthesia, and Medicine Stony Brook University
Director, Pediatric Intensive Care Unit Long Island Children’s Hospital
Stony Brook, NY
SCCM SSC Representative,
Past President, SCCM

8. Potential Conflicts of Interest
No direct or indirect potential financial conflict of interest as to any material presented in this presentation.

9. “Time Zero” Time Zero = time of presentation ED, Medical Floors, ICU
Both adult bundles time based
Most important time based elements:
Antibiotic timing
Resuscitation timing (EGDT)

10. Implications for Time Zero
New York State DOH
Mandated reporting of sepsis outcomes
Adherence to “evidence-based” protocols
NQF sepsis measures
Recently approved
Fear of being “dinged” for patients who did not meet criteria on triage in ED
Public reporting
Pay for Performance

11. Evaluating Severe Sepsis
Q1: Signs of SIRS – Adjusted for pediatric age-specific populations.
Q2: Suspected infection - clinical judgment to determine if there is a new potential site of infection.
Q3: Organ dysfunction – often discovered by an abnormal serum lactate value

12. Pediatric Considerations
Initial resuscitation
Antibiotics and source control
Fluid resuscitation
Inotropes/vasopressors/ vasodilators
ECMO
Corticosteroids 12

13. SSC 2012 Guidelines Initial Resuscitation
We suggest starting with face mask oxygen or if needed and available, high flow nasal cannula oxygen or nasopharyngeal CPAP for respiratory distress and hypoxemia. For improved circulation, peripheral intravenous access or intraosseus access can be used for fluid resuscitation and inotrope infusion when a central line is not available. If mechanical ventilation is required then cardio-vascular stability during intubation is more likely after these are achieved Grade 2C
The initial resuscitation section is new in the 2012 guidelines. It represents no new data but a simpler reorganization of the 2007 recommendations

14. SSC 2012 Guidelines Initial Resuscitation
We suggest that the therapeutic end points of resuscitation of septic shock be capillary refill of <2 secs, normal blood pressure for age, normal pulses with no differential between peripheral and central pulses, warm extremities, urine output >1 mL·kg-1·hr-1, and normal mental status in the first hour and SCV O2 > 70% and CI between 3.3 and 6.0 L/min/m2 thereafter Grade 2C
This section represents a reorganization of the 2007 guildiens

15. A Comparison of ACCM-PALS Guidelines to Standard Care on Outcome from Pediatric Septic Shock A Randomized Control Trial (de Oliveira et al Intens Care Med 2010)
102 Septic Shock
Patients
Central line to
RA/SVC or RA/IVC
No continuous
O2 sat monitoring
(n = 51)
Fluid resuscitated
Continuous
Goal normal perfusion
Goal O2 sat > 70%
De Oliveira and colleagues performed a randomized trial demonstrating that use of ACCM-PALS guidelines directed to ScVO2 > 70% reduced mortality compared to use of ACCM –PALS guidelines directed only to capillary refill and blood pressure

16. De Oliveira et al Intens Care Med 2010

17. De Oliveira et al Intens Care Med 2010

18. Before
0-6 h
6-72 h
Total
Crystalloid
Control
Intervention
P value
49 +/- 33
47 +/- 26
0.89
11 +/- 14
32 +/- 23
<
19 +/- 25
15 +/- 21
0.53
79 +/- 47
94 +/- 40
0.10
RBC
0.9 +/- 3.7
0.6 +/- 3.1
0.86
2.1 +/- 5.1
7.2 +/- 8.5
0.0053
5.6 +/- 7.1
4.4 +/- 8.0
0.26
8.6 +/- 7.91
12.1 +/- 11.2
0.14
N % RBC
5.9
3.9
1.0
15.7
45.1%
0.0023
43.1
31.4
0.31
58.8
68.6
0.41
% Additional Inotrope or Vasodilator
7.8%
31.4%
0.01
24.4%
27.4%
0.92
58.8%
0.05
When resuscitation was directed to ScVO2 saturation in the PICU, patients received more fluid resuscitation, more blood transfusions, more inotropes, and more vasodilators in order to increase cardiac output and oxygen delivery

19. Reduced Mortality with ACCM-PALS Guidelines compared to Standard Care for Pediatric Septic Shock - A Randomized Control Trial (de Oliveira Intens Care Med 2010)
102 Septic Shock
Patients
28 day Mortality
39.2%
20/51
P =
11.8%
6/51
Goal normal perfusion
Goal O2 sat > 70%
ScVO2 directed therapies resulted in a three fold reduction in mortality with a Number Needed to Treat of < 3 patients

20. de Oliveira et al Intens Care Med 2010
                                                                                                                           
Fig. 3 Kaplan–Meier estimates of mortality (28 days)
ScVO2 directed therapy improved outcome only in patients with low ScVO2
de Oliveira et al Intens Care Med 2010

21. SSC 2012 Guidelines Initial Resuscitation
We recommend following ACCM-PALS guidelines for the management of Septic Shock Grade 1C
We recommend reversal of unrecognized pneumothorax, pericardial tamponade, intra-abdominal hypertension, or endocrine emergencies in patients with refractory shock Grade 1C
Thes erecomemndtaion are unchanged

22. Figure 2
Surviving Sepsis Campaign: International Guidelines for Management of Severe Sepsis and Septic Shock:
Dellinger, R; Levy, Mitchell; Rhodes, Andrew; Annane, Djillali; Gerlach, Herwig; MD, PhD; Opal, Steven; Sevransky, Jonathan; Sprung, Charles; Douglas, Ivor; Jaeschke, Roman; Osborn, Tiffany; MD, MPH; Nunnally, Mark; Townsend, Sean; Reinhart, Konrad; Kleinpell, Ruth; PhD, RN-CS; Angus, Derek; MD, MPH; Deutschman, Clifford; MD, MS; Machado, Flavia; MD, PhD; Rubenfeld, Gordon; Webb, Steven; MB BS, PhD; Beale, Richard; Vincent, Jean-Louis; MD, PhD; Moreno, Rui; MD, PhD
Critical Care Medicine. 41(2): , February 2013.
DOI: /CCM.0b013e31827e83af
Above is the updated 2007 American College of Critical Care Medicine-Pediatric Advanced Life Support Hemodynamic Support
Time sensituive, goal directed guideline algorithm
Figure 2 . Algorithm for time sensitive, goal-directed stepwise management of hemodynamic support in infants and children. Reproduced from Brierley J, Carcillo J, Choong K, et al: Clinical practice parameters for hemodynamic support of pediatric and neonatal septic shock: 2007 update from the American College of Critical Care Medicine. Crit Care Med 2009; 37:
© 2013 by the Society of Critical Care Medicine and Lippincott Williams & Wilkins. Published by Lippincott Williams & Wilkins, Inc. 2

23. SSC 2012 Guidelines Antibiotics and source control
We recommend that empiric antibiotics be administered within 1 hr of the identification of sepsis. Although cultures are preferred they are not always possible. Antibiotics should not be delayed while awaiting attainment of cultures. The empiric drug choice should be changed as epidemic and endemic ecologies dictate (eg H1N1, MRSA, chloroquine resistant malaria) Grade 1D
These recommendations do not differ from 2008

24. SSC 2012 Guidelines Antibiotics and source control
We suggest clindamycin and anti-toxin therapies for toxic shock syndromes with refractory hypotension Grade 2D
We recommend early and aggressive source control Grade 1D
Clostridium difficile should be treated with enteral antibiotics if tolerated. Vancomycin is preferred for severe disease Grade 1A
These recommendations are added since 2008 in keeping with more detailed adult recommendations

25. SSC 2012 Guidelines Fluid resuscitation
In the industrialized world with access to inotropes, and mechanical ventilation, initial resuscitation of hypovolemic shock begins with infusion of isotonic crystalloids or albumin with boluses of up to 20 mL/kg (or albumin equivalent) over 5–10 min titrated to reversing hypotension, increasing urine output, and attaining normal capillary refill, peripheral pulses and level of consciousness without inducing hepatomegaly or rales. If hepatomegaly or rales exist then inotropic support should be implemented, not fluid resuscitation. In non-hypotensive children with severe hemolytic anemia (severe malarial anemia, or sickle cell anemia crises) blood transfusion is considered superior to crystalloid or colloid bolusing Grade 2C
We have re-emphasized the need to consider fluid overload and severe anemia as relative contraindications to fluid boluses. Fluid boluses are for hypovolemia. Inotropes are for poor cardiac function despite euvolemia. Blood is for severe anemia.

26. Can I Give Too Much Fluid?
You most certainly can give too much or too little!
Check for Hepatomegaly
Check for Rales
Evaluate MAP – CVP
Give diuretics
Use Dialysis CRRT if unsuccessful
You can definitely do harm if you do not attend to this!
Some children need zero mLs / kg of fluid because they are not hypovolemic, while others need up to 60 mL/kg or more of fluid during resuscitation to treat hypovolemia.
Severe anemia patients need blood not fluids. Fluids will worsen anemic shock (Hgb < 6 g/dL).

27. NY Protocols
Department of Health requiring hospitals to have protocols for early detection and management of sepsis, including pediatric protocols
Data will be reported to the State starting January, 2014
Current Pediatric measures under consideration:
Within 1 hour: establish IV access, administer fluid bolus, draw blood cultures, administer antibiotics

28. SSC 2012 Guidelines Inotropes/Vasopressors/Vasodilators
Begin peripheral inotropic support until central venous access can be attained in children
who are not responsive to fluid resuscitation Grade 2C
Patients with low cardiac output and elevated systemic vascular resistance states with normal blood pressure be given vasodilator therapies in addition to inotropes Grade 2C
We re-emphasize the need to start inotropes in euvolemic shock, and vaosdilators in non-hypotensive inotrope resistant euvolemic shock.

29. SSC 2012 Guidelines ECMO
We suggest consideration of ECMO for refractory pediatric septic shock and / or
respiratory failure (Grade 2C).
These guidelines have not changed since Outcomes for sepsis related refractory respiratory or cardiovascular failure are the same as non-sepsis related refractory respiratory or cardiovascular failure with ECMO use. New data suggests that central (chest) cannulation for septic shock can be more effective than peripheral (neck or groin) cannulation in children.

30. SSC 2012 Guidelines Corticosteroids
We recommend timely hydrocortisone therapy in children with fluid refractory, catecholamine resistant shock and suspected or proven absolute adrenal insufficiency (Grade 2 C).
These guidelines have not changed since Mortality from adrenal shock occurs in the first 8 hours in patients with catecholamine refractory shock. Hydrocortisone is indicated both for infection related and non-infection related Addisonian shock.

31. Pediatric Considerations
Activated Protein C (no longer available)
Blood Products and Therapies
Mechanical Ventilation
Sedation/Analgesia/Drug Toxicities
Glycemic Control
Diuretics and Renal Replacement Therapy 31

32. SSC 2012 Guidelines Blood Products and Therapies
Similar hemoglobin targets in children as in adults. During resuscitation of low superior vena cava oxygen saturation shock (< 70%), hemoglobin levels of 10 g/dL are targeted. After stabilization and recovery from shock and hypoxemia then a lower target > 7.0 g/ dL can be considered reasonable. (Grade 1B)
These recommendations do not vary from 2008 but new studies support this recommendation

33. Table 4.
Red blood cell transfusion thresholds in pediatric patients with sepsis *.
Karam, Oliver; Tucci, Marisa; MD, BSc; Ducruet, Thierry; Hume, Heather; Lacroix, Jacques; Gauvin, France; MD, MSc
Pediatric Critical Care Medicine. 12(5): , September 2011.
DOI: /PCC.0b013e3181fe344b
Table 4. Outcome measures
Although there were no significant differences in outcomes in children with sepsis in the
Conservative (transfuse for Hgb < 7 g/dL) vs Liberal (transfuse for Hgb < 9.5 g/dL) arms the
mortality rate was 10% in the Conservative group and 3% in the Liberal group (p = 0.08).
In light of the de Oliveira study findings of improved outcomes with transfusions given for
Low ScVO2 shock we recommend the liberal strategy when ScVO2 is < 70%.
In this retrospective post-hoc analysis of a larger randomized study of restrictive vs liberal use of transfusion for anemia which excluded patients in unstable shock, these investigators evaluated the severe sepsis sub-group only. Although there were no significant differences in outcomes in children with sepsis in the Conservative (transfuse for Hgb < 7 g/dL) vs Liberal (transfuse for Hgb < 9.5 g/dL) arms the 28 day mortality rate was 10% in the Conservative group and 3% in the Liberal group (p = 0.08).
In lieu of the de Oliveira study findings of improved outcomes with transfusions given for Low ScVO2 shock we recommend the liberal strategy when ScVO2 is < 70%.
©2011The Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies. Published by Lippincott Williams & Wilkins, Inc. 2

34. SSC 2012 Guidelines Blood Products and Therapies
Similar platelet transfusion targets in children as in adults (Grade 2C)
Use plasma therapies in children to correct sepsis induced thrombotic purpura disorders including progressive Disseminated Intravascular Coagulation, Secondary Thrombotic Microangiopathy, and Thrombotic Thrombocytopenic Purpura (Grade 2C)
There is no pediatric literature to suggest using different platelet thresholds. Plasma exchange is used in adults and children with infection related thrombotic microangiopathies.

35. SSC 2012 Guidelines Mechanical Ventilation
We suggest providing lung-protective strategies during mechanical ventilation (Grade 2 C).
No new recommendations since Lung protection is used in children with ARDS

36. SSC 2012 Guidelines Sedation/Analgesia/Drug Toxicities
We recommend use of sedation with a sedation goal in critically ill mechanically ventilated patients with sepsis (Grade 1D).
Monitor drug toxicity because drug metabolism is reduced in severe sepsis putting children at greater risk of adverse drug related events (Grade 2C)
Drug toxicities are common in children with sepsis

37. SSC 2012 Guidelines Glycemic Control
Control hyperglycemia using a similar target as in adults < 180 mg/dL.
Glucose infusion should accompany insulin therapy in newborns and children because some hyperglycemic children make no insulin whereas others are insulin resistant
(Grade 2C).
This is not a new recommendation since 2008.

38. There were no differences in outcome fours years later in the
From: Neurocognitive Development of Children 4 Years After Critical Illness and Treatment With Tight Glucose Control:  A Randomized Controlled Trial
JAMA. 2012;308(16): doi: /jama
There were no differences in
outcome fours years later in the
composite of neurological disability
and survival between the
Tight Glycemic control and Usual
Glycemic control study in the Leuven
PICU. There was an improved score in
one measure of cognition in the Tight
Glycemic control group even though
episodes of hypoglycemia had been
more prevalent in the PICU for this
treatment arm
Vlasselaers and colleagues performed a randomized study in a general PICU with 70% CICU patients that showed increased 28 day survival with strict glycemic control and the expense of increased hypoglycemia. In this follow-up of the study there were no differences in outcome fours years later in the composite of neurological disability and survival between the Tight Glycemic control and Usual Glycemic control study in the Leuven PICU. There was an improved score in one measure of cognition in the Tight Glycemic control group even though episodes of hypoglycemia had been more prevalent in the PICU for this treatment arm.
Two additional predominantly CICU population studies not related to sepsis also showed no effect of tight glycemic control on survival.

39. SSC 2012 Guidelines Diuretics and Renal Replacement
Use diuretics to reverse fluid overload, and if unsuccessful then continuous veno-venous hemofiltration (CVVH) or intermittent dialysis to prevent > 10% total body weight fluid overload (Grade 2C).
This is not a new recommendation since Once appropriate fluid resuscitation is performed in the first hour then careful monitoring of fluid balance is required. If the kidney has been ischemic for a sufficient period of time then diuretics are required to maintain fluid balance and prevent subsequent fluid overload. If unsuccessful then extracorporeal renal support is recommended.

40. Pediatric Considerations
DVT prophylaxis
Stress Ulcer Prophylaxis
Nutrition 40

41. SSC 2012 Guidelines DVT prophylaxis
No graded recommendations on the use of DVT prophylaxis in pre-pubertal
children with severe sepsis.

42. SSC 2012 Guidelines Stress Ulcer Prophylaxis
No recommendations on the use of stress ulcer prophylaxis in pre-pubertal children with sepsis

43. SSC 2012 Guidelines Nutrition
Enteral nutrition given to children who can be fed enterally, and parenteral feeding in those who cannot (Grade 2 C)
This is not a new recommendation since 2008

44. What about Lactate? Not included in 2012 Guidelines for Pediatrics
Infrequently elevated in children
May be useful if elevated
This is not a new recommendation since 2008

45. Questions?