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

NCT04621539 | Completed

• 1 other identifier: 58259
• Study Type: observational
• Target: 2,125
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Infection

Keywords

Sepsis; Pregnancy; qSOFA; Systemic Inflammatory Response Syndrome

Outcome Measures

Primary Outcomes (3)

• Admission to intensive care unit

  need or admission to an intensive care unit

  28 days

• Use of vasopressors

  use of vasoactive drugs (norepinephrine, epinephrine, vasopressin)

  28 days

• Prolonged ICU stay

  Stay in intensive care unit for 72 hours

  28 days

Secondary Outcomes (1)

• Additional interventions

  28 days

Study Arms (2)

Infected without an SMO

Defined as an acute infection not associated with admission to the intensive care unit (ICU), mechanical ventilation, or the use of vasopressors.

Infected with an SMO

defined as an acute infection associated with intensive care unit (ICU) admission, mechanical ventilation, or vasopressor use.

Eligibility Criteria

• Age: 14 Years - 49 Years
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Grupo de Investigación en Cuidados Intensivos y Obstetricia: lead

Study Sites (1)

Gestion Salud

Cartagena, Departamento de Bolívar, 130015, Colombia

Location

Related Publications (8)

• Say L, Chou D, Gemmill A, Tuncalp O, Moller AB, Daniels J, Gulmezoglu AM, Temmerman M, Alkema L. Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health. 2014 Jun;2(6):e323-33. doi: 10.1016/S2214-109X(14)70227-X. Epub 2014 May 5.

  PMID: 25103301 BACKGROUND

• Surgers L, Valin N, Carbonne B, Bingen E, Lalande V, Pacanowski J, Meyohas MC, Girard PM, Meynard JL. Evolving microbiological epidemiology and high fetal mortality in 135 cases of bacteremia during pregnancy and postpartum. Eur J Clin Microbiol Infect Dis. 2013 Jan;32(1):107-13. doi: 10.1007/s10096-012-1724-5. Epub 2012 Aug 21.

  PMID: 22907333 BACKGROUND

• Acosta CD, Bhattacharya S, Tuffnell D, Kurinczuk JJ, Knight M. Maternal sepsis: a Scottish population-based case-control study. BJOG. 2012 Mar;119(4):474-83. doi: 10.1111/j.1471-0528.2011.03239.x. Epub 2012 Jan 18.

  PMID: 22251396 BACKGROUND

• Kankuri E, Kurki T, Carlson P, Hiilesmaa V. Incidence, treatment and outcome of peripartum sepsis. Acta Obstet Gynecol Scand. 2003 Aug;82(8):730-5. doi: 10.1034/j.1600-0412.2003.00265.x.

  PMID: 12848644 BACKGROUND

• 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.

  PMID: 1303622 BACKGROUND

• 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.

  PMID: 26903338 BACKGROUND

• Jain S, Guleria K, Suneja A, Vaid NB, Ahuja S. Use of the Sequential Organ Failure Assessment score for evaluating outcome among obstetric patients admitted to the intensive care unit. Int J Gynaecol Obstet. 2016 Mar;132(3):332-6. doi: 10.1016/j.ijgo.2015.08.005. Epub 2015 Dec 2.

  PMID: 26792141 BACKGROUND

• Arts DG, de Keizer NF, Vroom MB, de Jonge E. Reliability and accuracy of Sequential Organ Failure Assessment (SOFA) scoring. Crit Care Med. 2005 Sep;33(9):1988-93. doi: 10.1097/01.ccm.0000178178.02574.ab.

  PMID: 16148470 BACKGROUND

Related Links

• Maternal mortality - WHO
• Weekly Epidemiological Bulletin, number 21 of 2017 (May 21 - May 27)

MeSH Terms

Conditions

Infections; Sepsis; Systemic Inflammatory Response Syndrome

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Carmelo R Dueñas-Castell, Msc

  Gestion Salud IPS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: November 9, 2020
• Study Start: January 1, 2018
• Primary Completion: November 13, 2019
• Study Completion: November 13, 2019
• Last Updated: November 9, 2020

Record last verified: 2020-11

Locations

CO (1)