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

November 5, 2020 updated by: Fundación Grupo de Investigación en Cuidados Intensivos y Obstetricia

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

2125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Bolivar
      • Cartagena, Bolivar, Colombia, 130015
        • Gestion Salud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 49 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Admission to intensive care unit
Time Frame: 28 days
need or admission to an intensive care unit
28 days
Use of vasopressors
Time Frame: 28 days
use of vasoactive drugs (norepinephrine, epinephrine, vasopressin)
28 days
Prolonged ICU stay
Time Frame: 28 days
Stay in intensive care unit for 72 hours
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Grupo de Investigación en Cuidados Intensivos y Obstetricia

Investigators

  • Principal Investigator: Carmelo R Dueñas-Castell, Msc, Gestion Salud IPS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

November 13, 2019

Study Completion (Actual)

November 13, 2019

Study Registration Dates

First Submitted

October 8, 2020

First Submitted That Met QC Criteria

November 5, 2020

First Posted (Actual)

November 9, 2020

Study Record Updates

Last Update Posted (Actual)

November 9, 2020

Last Update Submitted That Met QC Criteria

November 5, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 58259

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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