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

Severe Infection Clinical Trial

— COLOSSAL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04621539
• Other study ID #: 58259
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: November 13, 2019

Study information

• Verified date: November 2020
• Source: Fundación Grupo de Investigación en Cuidados Intensivos y Obstetricia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2125
• Est. completion date: November 13, 2019
• Est. primary completion date: November 13, 2019
• Gender: Female
• Age group: 14 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Infection
• Sepsis
• Severe Infection

Locations

Country	Name	City	State
Colombia	Gestion Salud	Cartagena	Bolivar

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Grupo de Investigación en Cuidados Intensivos y Obstetricia

Country where clinical trial is conducted

Colombia, 

References & Publications (8)

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. — View Citation

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. — View 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. Review. — View Citation

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. — View Citation

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. — View Citation

Say L, Chou D, Gemmill A, Tunçalp Ö, Moller AB, Daniels J, Gülmezoglu 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. Review. — View 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Admission to intensive care unit	need or admission to an intensive care unit	28 days
Primary	Use of vasopressors	use of vasoactive drugs (norepinephrine, epinephrine, vasopressin)	28 days
Primary	Prolonged ICU stay	Stay in intensive care unit for 72 hours	28 days
Secondary	Additional interventions	need for surgery (cesarean section - emergency hysterectomy, hysterectomy, chest tubes, etc.), invasive mechanical ventilation, use of arterial line, among others.	28 days

External Links

•   Maternal mortality - WHO
•   Second Report of the National Health Observatory: Mortality 1998-2011 and health situation in land border municipalities in Colombia
•   Weekly Epidemiological Bulletin, number 21 of 2017 (May 21 - May 27)