Clinical trial NCT04621539: Validation of the Quick Sequential [Sepsis-related] Organ Failure Assessment (qSOFA) in Obstetric Patients
Official title: Validation of the Quick Sequential [Sepsis-related] Organ Failure Assessment (qSOFA) Predictive Model in the Prediction of Severe Infection - Sepsis in Obstetric Patients and Adverse Neonatal Outcomes: a Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Infection
Keywords: Sepsis
Pregnancy
qSOFA
Systemic Inflammatory Response Syndrome
Lead sponsor: Fundación Grupo de Investigación en Cuidados Intensivos y Obstetricia
Sponsor class: OTHER
First posted: 2020-11-09
Enrollment: 2125
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 49
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women, childbirth or within 42 days of termination of pregnancy, with infectious symptoms of any kind (obstetric - non-obstetric) who attend and are hospitalized in the selected clinics during the study period.

Brief summary: Research problem: In 1991, the terms Systemic Inflammatory Response Syndrome (SIRS), severe sepsis, and septic shock were introduced, based on the pro-inflammatory theory, conforming to a list of classification criteria for each one. New criteria were recently created in search of coherence with the pathophysiological process that generates the infection in the host: SOFA and qSOFA scores. Neither of these two criteria has been standardized in the obstetric patient, taking into account the physiological alteration of many of the clinical and laboratory parameters that occur in pregnancy. The question that arises then is: Are the new sepsis criteria qSOFA and SOFA valid in comparison with the previous SIRS criteria for predicting adverse maternal and neonatal outcomes in obstetric patients diagnosed with infection? Aim: To evaluate the predictive model quick Sequential \[Sepsis-related\] Organ Failure Assessment (qSOFA) in comparison with the SIRS criteria for the prognosis of severe infection-sepsis in obstetric patients and adverse neonatal outcomes in different cities of Colombia.

Methodology: a longitudinal prospective cohort multicenter study will be carried out in selected centers in Colombia, with a data collection duration of at least 12 months. Data will be collected on clinical characteristics, health outcomes, and medical practices. Study participants will be followed during their stay at the health center. Follow-up will end at hospital discharge, transfer to a facility outside of participating geographic areas, or death. Neonates born to mothers included in the study will be followed until discharge from the hospital or 7 days after birth if they are still in the hospital, whichever comes first.

Expected results: This study seeks to evaluate the predictive model q SOFA and the prognosis of sepsis in obstetrics in comparison with the SIRS criteria, hoping to find that qSOFA is superior to the SIRS criteria for the identification of which obstetric patients diagnosed with an infection they will progress to sepsis and which patients with sepsis progress to septic shock, this would translate both at the maternal and neonatal level in a reduction of adverse events, prolonged stays, disabilities, sequelae, in addition to allowing preventive actions and control, which finally translate into protocols that allow better management of this entity.


Eligibility criteria: Inclusion Criteria:

* Patients in a state of pregnancy with a single fetus between 14 and 49 years old.
* Pregnant women (any gestational age) defined as a positive gravindex test and an obstetric ultrasound to prove it.
* Any suspected or confirmed infection during current hospital stay (primary admission or readmission) with or without organ dysfunction
* Any clinical signs suggestive of infection (eg, fever)
* Request for culture of body fluids (blood, urine, cerebrospinal fluid, etc.) or swab specimen (nasopharyngeal, oropharyngeal);
* Non-prophylactic use of antibiotics or other antimicrobials during admission or during hospital stay.
* Any health care related infection (eg, surgical site, episiotomy, IV, venipuncture, urinary catheterization, central line, etc.)
* Urinary tract infection of the lower urinary tract that requires hospitalization and in-hospital management for more than 48 hours.
* Herpes simplex, herpes zoster (shingles) with associated liver failure.

Note: observations on the inclusion criteria:

* Eligible women who remain in the health center for 12 hours or more, regardless of formal administrative admission, will be included in the study.
* Eligible women admitted or readmitted to a participating health center, regardless of length of hospital stay, will be included in the study.

Exclusion Criteria:

* Pregnant women of any age who do not sign the informed consent.
* Pregnant minors who do not sign the consent.
* Any non-serious or localized infection

  * Vaginosis, candidiasis
  * Fungal skin infections (athlete's foot, ringworm)
  * Otitis o Pharyngitis
* Any chronic uncomplicated infection

  * Sexually transmitted infections (gonorrhea, syphilis, Trichomonas, chlamydia, hepatitis, HIV).
  * Tuberculosis.
* Any colonization Microorganisms without clinical signs / symptoms)

  * Known vaginal, urethral and / or rectal colonization of group B beta-hemolytic streptococcus.
  * Asymptomatic bacteriuria
  * Known oropharyngeal colonization
* Patients with surgical wound infection other than caesarean section (hysterectomy, laparotomy or others)
* Any iatrogenic / hyperthermic hypothermia (eg related to epidural, thyroid storm, prostaglandin administration) during hospital stay.
* Use of any prescription of prophylactic antibiotics (eg, for colonization of beta-hemolytic streptococcus group B, after cesarean section, manual removal of the placenta, vaginal delivery);
* Patients referred from other institutions with more than 24 hours of management

Primary outcomes:
measure: Admission to intensive care unit
timeFrame: 28 days
measure: Use of vasopressors
timeFrame: 28 days
measure: Prolonged ICU stay
timeFrame: 28 days
Secondary outcomes:
measure: Additional interventions
timeFrame: 28 days
Other outcomes:
Locations:
city: Cartagena
country: Colombia
facility: Gestion Salud
state: Bolivar
Study officials:
affiliation: Gestion Salud IPS
name: Carmelo R Dueñas-Castell, Msc
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Bone RC, Balk RA, Cerra FB, Dellinger RP, Fein AM, Knaus WA, Schein RM, Sibbald WJ. Definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. The ACCP/SCCM Consensus Conference Committee. American College of Chest Physicians/Society of Critical Care Medicine. Chest. 1992 Jun;101(6):1644-55. doi: 10.1378/chest.101.6.1644.
citation: Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
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