Validation of the Quick Sequential [Sepsis-related] Organ Failure Assessment (qSOFA) in Obstetric Patients
NCT ID: NCT04621539
Last Updated: 2020-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2125 participants
OBSERVATIONAL
2018-01-01
2019-11-13
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Infected with an SMO
defined as an acute infection associated with intensive care unit (ICU) admission, mechanical ventilation, or vasopressor use.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
14 Years
49 Years
FEMALE
No
Sponsors
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Fundación Grupo de Investigación en Cuidados Intensivos y Obstetricia
OTHER
Responsible Party
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Principal Investigators
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Carmelo R Dueñas-Castell, Msc
Role: PRINCIPAL_INVESTIGATOR
Gestion Salud IPS
Locations
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Gestion Salud
Cartagena, Departamento de Bolívar, Colombia
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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Maternal mortality - WHO
Weekly Epidemiological Bulletin, number 21 of 2017 (May 21 - May 27)
Other Identifiers
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58259
Identifier Type: -
Identifier Source: org_study_id