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CMECNE

SMFM & CMQCC Guidelines: Making the Diagnosis of Sepsis in Pregnancy

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Learning Objectives and CME/Disclosure Information

This activity is intended for healthcare providers delivering care to women and their families.

After completing this activity, the participant should be better able to:

1. Discuss the definitions for sepsis and septic shock
2. Describe the physiologic differences that may impact non-pregnant sepsis scoring systems

Estimated time to complete activity: 0.25 hours

Faculty:

Susan J. Gross, MD, FRCSC, FACOG, FACMG
President and CEO, The ObG Project

Disclosure of Conflicts of Interest

Postgraduate Institute for Medicine (PIM) requires instructors, planners, managers and other individuals who are in a position to control the content of this activity to disclose any real or apparent conflict of interest (COI) they may have as related to the content of this activity. All identified COI are thoroughly vetted and resolved according to PIM policy. PIM is committed to providing its learners with high quality CME activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest.

Faculty: Susan J. Gross, MD, receives consulting fees from Cradle Genomics, and has financial interest in The ObG Project, Inc.

Planners and Managers: The PIM planners and managers, Trace Hutchison, PharmD, Samantha Mattiucci, PharmD, CHCP, Judi Smelker-Mitchek, MBA, MSN, RN, and Jan Schultz, MSN, RN, CHCP have nothing to disclose.

Method of Participation and Request for Credit

Fees for participating and receiving CME credit for this activity are as posted on The ObG Project website. During the period from Feb 21 2019 through Feb 21 2021, participants must read the learning objectives and faculty disclosures and study the educational activity.

If you wish to receive acknowledgment for completing this activity, please complete the post-test and evaluation. Upon registering and successfully completing the post-test with a score of 100% and the activity evaluation, your certificate will be made available immediately.

For Pharmacists: Upon successfully completing the post-test with a score of 100% and the activity evaluation form, transcript information will be sent to the NABP CPE Monitor Service within 4 weeks.

Joint Accreditation Statement

In support of improving patient care, this activity has been planned and implemented by the Postgraduate Institute for Medicine and The ObG Project. Postgraduate Institute for Medicine is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

Physician Continuing Medical Education

Postgraduate Institute for Medicine designates this enduring material for a maximum of 0.25 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Continuing Nursing Education

The maximum number of hours awarded for this Continuing Nursing Education activity is 0.2 contact hours.

Read Disclaimer & Fine Print

SUMMARY:

SMFM  and CMQCC have both released guidance on sepsis in pregnancy. Sepsis remains a major cause of maternal morbidity and mortality. Sepsis is considered a preventable cause of maternal mortality. Because vital signs are altered in pregnancy (and may mimic infection such as increased maternal heart rate), both professional organizations emphasize the importance of recognizing that sepsis screening tools may need modification during pregnancy.  There are multiple tools to screen and diagnose sepsis. SMFM provides the SOFA method and CMQCC has developed its own algorithm (see details below)

Risk Factors

  • Nulliparity
  • Black race
  • Insurance: public or none
  • Cesarean delivery
  • ART
  • Multiple gestation

Note: Presence of co-morbidities increases maternal mortality risk

Definitions and Clinical Criteria

The Third Internal Consensus Definitions for Sepsis and Septic Shock (2016)

Definitions

  • Sepsis: Life-threatening organ dysfunction caused by a dysregulated host response to infection
  • Septic shock: Sepsis with circulatory and cellular/metabolic abnormalities profound enough to substantially increase mortality

Clinical Criteria

  • Sepsis
    • Suspected or documented infection and an acute increase of ≥2 SOFA (Sequential Organ Failure Assessment) points (see ‘Key Points’ below)
      • Proxy for organ dysfunction
  • Septic Shock
    • Sepsis and vasopressor therapy needed to
      • Elevate MAP ≥ 65 mmHg and lactate > 2 mmol/L (18 mg/dL) after adequate fluid resuscitation

qSOFA System to Rapidly Identify Those at Risk

  • Bedside tool used outside the ICU
  • Assign 1 point each to the following criteria
    • SBP: ≤100 mmHg
    • Respiratory rate: ≥22 breaths per min
    • Altered mentation: Glasgow coma scale<15
  • If score ≥2
    • Assess for organ dysfunction
    • Escalate therapy
    • Increase monitoring and transfer to ICU may be required

CMQCC 2-Step System for Maternal Sepsis Screening and Diagnosis

Step 1 – Sepsis Screen: ≥2 elements considered positive 

  • Oral temperature: < 36°C (98.6°F) or ≥ 38°C (100.4°F)
  • HR: > 110 beats per minute and sustained for 15
    minutes
  • RR: > 24 breaths per minute and sustained for
    15 minutes
  • WBC: > 15,000/mm3 or < 4,000/mm3 or >
    10% immature neutrophils (bands)

Note: Verify abnormal values | Obtain a complete set of vital signs (i.e., include 02 sat) and repeat in 15 minutes | Do not wait for fever if there are other suspicious clinical signs that infection is present | Corticosteroids will elevate WBCs but peak expected within 24 hours and should be baseline again after 96 hours

If Step 1 Positive – Obtain the following 

  • Laboratory values: CBC
    • Coags: Prothrombin time | INR | PTT
    • Comprehensive metabolic panel
    • Venous lactic acid
  • Bedside assessment
    • Urine output (Foley catheter with urometer
    • Pulse oximetry
    • Mental status assessment

Step 2 Confirmation: CMQCC Sepsis Diagnosis Algorithm (only 1 criteria required for sepsis diagnosis) 

  • Respiratory function
    • Need for invasive or non-invasive mechanical
      ventilation or
    • PaO2/FiO2 < 300
  • Coag studies
    • Platelets < 100 x 109/L or
    • INR: > 1.5 or
    • PTT: > 60 seconds
  • Liver function
    • Bilirubin > 2 mg/dL
  • Cardiovascular function (persistent hypotension)
    • SBP < 85 mm Hg or
    • MAP < 65 mm Hg or
    • > 40 mm Hg decrease in SBP
  • Renal function
    • Creatinine > 1.2 mg/dL or
    • Doubling of creatinine or
    • Urine output < 0.5 mL/kg/hour (for 2 hours)
  • Mental status
    • Agitation | Confusion | Unresponsiveness
  • Lactic acid
    • 2 mmol/L
    • Can be used for diagnosis in the absence of labor | For women in labor with an elevated lactic acid and positive step 1 screen but negative step 2 confirmation, CMQCC recommends close surveillance with repeated bedside evaluation and repeated lactic acid levels over time

Note: CMQCC has not evaluated its algorithm in a research setting, but based on clinical practice data sets, the anticipated performance is estimated to be 97% for sensitivity and 99% for specificity

Sepsis and Septic Shock are Medical Emergencies

  • Resuscitation and treatment should begin immediately
  • Consider sepsis in pregnant women “otherwise unexplained end-organ damage in the presence of an infectious process”
  • Treat regardless of whether or not fever is present
  • Multiple organ systems aside from cardiovascular, pulmonary and CNS may be affected including
    • GI (ileus) | Hepatic injury or failure | Renal injury or failure | Coagulation (low platelets or DIC) | Endocrine system (adrenal / insulin resistance)
  • CMQCC emphasizes that a MAP of <65 mm Hg that persists after a 30ml/kg fluid load in the setting of infection “directly defines septic shock”

KEY POINTS:

SOFA Score: Sepsis defined as an acute increase of 2 or more points

  • Respiratory system: PaO2/FiO2 (mmHg)
    • ≥ 400 score 0
    • < 400 score +1
    • < 300 score +2
    • < 200 and mechanically ventilated score +3
    • < 100 and mechanically ventilated score +4
  • Nervous system: Glasgow coma scale
    • 15 score 0
    • 13–14 score +1
    • 10–12 score +2
    • 6–9 score +3
    • < 6 score +4
  • Cardiovascular system: MAP or vasopressors required
    • MAP ≥ 70 mmHg score 0
    • MAP < 70 mmHg score +1
    • dopamine ≤ 5 µg/kg/min or dobutamine (any dose) score +2
    • dopamine > 5 µg/kg/min OR epinephrine ≤ 0.1 µg/kg/min OR norepinephrine ≤ 0.1 µg/kg/min score +3
    • dopamine > 15 µg/kg/min OR epinephrine > 0.1 µg/kg/min OR norepinephrine > 0.1 µg/kg/min score +4
  • Liver: Bilirubin (mg/dl) [μmol/L]
    • < 1.2 [< 20] score 0
    • 1.2–1.9 [20-32] score +1
    • 2.0–5.9 [33-101] score +2
    • 6.0–11.9 [102-204] score +3
    • 12.0 [> 204] score +4
  • Coagulation: Platelets×103/µl
    • ≥ 150 score 0
    • < 150 score +1
    • < 100 score +2
    • < 50 score +3
    • < 20 score +4
  • Kidneys: Creatinine (mg/dl) [μmol/L] (or urine output)
    • < 1.2 [< 110] score 0
    • 1.2–1.9 [110-170] score +1
    • 2.0–3.4 [171-299] score +2
    • 3.5–4.9 [300-440] (or < 500 ml/d) score +3
    • 5.0 [> 440] (or < 200 ml/d) score +4

Clinical Features and Considerations Specific to Pregnancy if Using SOFA

  • SOFA does not take in to account the physiologic changes of pregnancy
    • Creatinine at ≥2 mg/dL: This SOFA threshold above pregnancy norm
    • MAP: Healthy pregnant women may have MAP <70 mmHg
  • SOMANZ (Society of Obstetric Medicine Australia and New Zealand) developed an obstetrically modified qSOFA score for pregnant women (1 point each; ≥2 escalate)
    • SBP <90 mmHg
    • Respiratory rate >25/min
    • Altered mental status (any non-alert state)
  • SOMANZ also made modifications to the SOFA scoring system
    • Simplified to account for lack of Glasgow score use on L&D
    • Healthy pregnancy will usually have MAP <70 mmHg so premorbid blood pressure should be taken in to consideration
    • Positive score is a change of ≥2 so scores of 3 and 4 removed for sake of simplicity

SOMANZ obstetrically modified SOFA- (omSOFA)

  • Respiration: PaO2/FIO2
    • ≥400 score 0
    • 300 – <400 score +1
    • <300 score +2
  • Coagulation: Platelets, x106/L
    • ≥150 score 0
    • 100-150 score +1
    • <100 score +2
  • Liver: Bilirubin (mg/dl) [μmol/L]
    • ≤1.2 [≤20] score 0
    • 1.2-1.9 [20-32] score +1
    • >1.9 [>32] score +2
  • Cardiovascular: MAP (mmHg)
    • ≥70 score 0
    • <70 score +1
    • Vasopressors required score +2
  • Central Nervous System
    • Alert score 0
    • Rousable by voice score +1
    • Rousable by pain score +2
  • Renal: Creatinine (mg/dl) [μmol/L]
    • ≤1.0 [≤90] score 0
    • 1.0-1.4 [90-120] score +1
    • >1.4 [>120] score +2

Learn More – Primary Sources:

SMFM Consult Series: Sepsis during pregnancy and the puerperium

The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3)

qSOFA calculator

Serial Evaluation of the SOFA Score to Predict Outcome in Critically Ill Patients

JAMA: Consensus Definitions for Sepsis and Septic Shock

SOMANZ Guidelines for the Investigation and Management of Sepsis in Pregnancy

CMQCC: Improving Diagnosis and Treatment of Maternal Sepsis

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Related ObG Topics:

SMFM & CMQCC Guidelines: Management of Sepsis in Pregnancy
Chorioamnionitis: ACOG Committee Opinion on Diagnosis and Management
What is the Best Practices Prevention Bundle for Post Cesarean Infection?
ARDS, Critical Care and COVID-19: ‘Surviving Sepsis Campaign’ Guidelines and Key Points

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