Severe InfectionCOLOSSALNCT04621539
Validation of the Quick Sequential [Sepsis-related] Organ Failure Assessment (qSOFA) in Obstetric Patients
An observational study of Severe Infection, run by Fundación Grupo de Investigación en Cuidados Intensivos y Obstetricia at 1 site in Colombia.
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. Read more about this study
- Who is it for?
- Ages 14 to 49 years, women only
- Conditions the study is for
- Severe Infection
- How many people
- 2,125 participants
- Where
- 1 siteColombia
- Study dates
- 1 Jan 2018to 13 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 49 years
- Women only
- Child, Adult
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.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Medical subject headings
- Infections, Sepsis, Systemic Inflammatory Response Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Admission to intensive care unit
need or admission to an intensive care unit
Measured: 28 days
Use of vasopressors
use of vasoactive drugs (norepinephrine, epinephrine, vasopressin)
Measured: 28 days
Prolonged ICU stay
Stay in intensive care unit for 72 hours
Measured: 28 days
Secondary outcomes (1)
Additional interventions
need for surgery (cesarean section - emergency hysterectomy, hysterectomy, chest tubes, etc.), invasive mechanical ventilation, use of arterial line, among others.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start1 Jan 2018
- Primary completion13 Nov 2019
- Study completion13 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Severe InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Grupo de Investigación en Cuidados Intensivos y Obstetricia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carmelo R Dueñas-Castell, Msc, Principal investigator, Gestion Salud IPS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04621539
- Sponsor's protocol ID
- 58259
- Acronym
- COLOSSAL
- Status last verified
- Nov 2020
- First submitted
- 8 Oct 2020
- Last updated
- 9 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 25103301Surgers 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.
PubMed 22907333Acosta 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.
PubMed 22251396Kankuri 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.
PubMed 12848644Bone 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.
PubMed 1303622Singer 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.
PubMed 26903338Jain 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.
PubMed 26792141Arts 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.
PubMed 16148470
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04621539
- Acronym / sponsor ID
- COLOSSAL / 58259
- Conditions
- Severe Infection
- Keywords
- Sepsis, Pregnancy, qSOFA, Systemic Inflammatory Response Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,125 participants (actual)
- Lead sponsor
- Fundación Grupo de Investigación en Cuidados Intensivos y ObstetriciaUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 13 Nov 2019 (actual)
- Study completion
- 13 Nov 2019 (actual)
- First posted
- 9 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 14 to 49 years
- Sex
- Female only
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (12 listed)
- 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);
Key exclusion criteria (17 listed)
- 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
- Any chronic uncomplicated infection
- Any colonization Microorganisms without clinical signs / symptoms)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Additional interventions
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
- Background: PubMed 25103301Say 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.
- Background: PubMed 22907333Surgers 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.
- Background: PubMed 22251396Acosta 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.
- Background: PubMed 12848644Kankuri 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.
- Background: PubMed 1303622Bone 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.
- Background: PubMed 26903338Singer 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.
- Background: PubMed 26792141Jain 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.
- Background: PubMed 16148470Arts 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.
- Maternal mortality - WHOLink provided by the sponsor.
- Weekly Epidemiological Bulletin, number 21 of 2017 (May 21 - May 27)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmelo R Dueñas-Castell, Msc principal investigator
Gestion Salud IPS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Infection, run by Fundación Grupo de Investigación en Cuidados Intensivos y Obstetricia at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Admission to intensive care unit (time frame: 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04621539, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2020.