Validation of the Quick Sequential [Sepsis-related] Organ Failure Assessment (qSOFA) in Obstetric Patients

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.

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Key information

Conditions

Severe Infection Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Systemic Inflammatory Response Syndrome

Age range

14 year–49 year

Sex eligibility

Female

Study type

Observational

Primary location

Gestion Salud

Cartagena, Departamento de Bolívar, 130015, Colombia

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Admission to intensive care unit

Time frame: 28 days

need or admission to an intensive care unit
Use of vasopressors

Time frame: 28 days

use of vasoactive drugs (norepinephrine, epinephrine, vasopressin)
Prolonged ICU stay

Time frame: 28 days

Stay in intensive care unit for 72 hours

Secondary outcomes

Additional interventions

Time frame: 28 days

need for surgery (cesarean section - emergency hysterectomy, hysterectomy, chest tubes, etc.), invasive mechanical ventilation, use of arterial line, among others.

Sponsors and collaborators

Lead sponsor

Fundación Grupo de Investigación en Cuidados Intensivos y Obstetricia

Other

Registry information

Official study 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

Acronym: COLOSSAL

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Nov 9, 2020
Registry last updated: Nov 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed