Severe SepsisNCT01841190
Prognostic Evaluation Of Severe Sepsis And Septic Shock. Procalcitonin Versus Delta Sofa
An observational study of Severe Sepsis and Septic Shock, run by Hospital Sao Domingos at 2 sites in Brazil.
Trial summary
The purpose of this study is to compare the tendency of plasma concentration and clearance of procalcitonin in the first 24 and 48 hours of management of patients with severe sepsis and septic shock with another marker of early prognosis represented by 48 hours delta sofa. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Sepsis, Septic Shock
- How many people
- 128 participants
- Where
- 2 sitesBrazil
- Study dates
- May 2012to Jan 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with severe sepsis and septic shock admitted to a multidisciplinary ICU
Who may be able to join
- Adult patients admitted to the ICU
- severe sepsis and septic shock
Who cannot join
- Children
- Pregnant.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites, 2 recruiting
- Recruiting
Hospital Sao Domingos
São Luís, Maranhão, 65060-642
JOSE R AZEVEDO, MD, 55 98 32168110, jrazevedo@elo.com.br
JOSE R AZEVEDO, MD
- Recruiting
Hospital Sao Domingos
São Luís, Maranhão, 65060-642
ORLANDO J TORRES, PhD, 559832168100, o.torres@uol.com.br
About this study
Official title: PROGNOSTIC EVALUATION OF SEVERE SEPSIS AND SEPTIC SHOCK. PROCALCITONIN VERSUS DELTA SOFA
The purpose of this study is to compare the tendency of plasma concentration and clearance of procalcitonin in the first 24 and 48 hours of management of patients with severe sepsis and septic shock with another marker of early prognosis represented by 48 hours delta sofa.
Read the detailed description
This is a cohort prospective observational study that will include adult patients admitted to a multidisciplinary ICU of a tertiary hospital.
- Conditions
- Severe Sepsis, Septic Shock
- Keywords
- Prognosis, Sepsis, Septic shock, Procalcitonin, SOFA
- Medical subject headings
- Sepsis, Shock, Septic
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 |
|---|---|---|
| PROCALCITONIN | Not described | |
| DELTA SOFA | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
MORTALITY
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 posted26 Apr 2013 (estimated)
- Study startMay 2012
- Primary completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe SepsisStudies 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
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Sao Domingos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Raimundo Araujo de Azevedo, Hospital Sao Domingos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01841190
- Sponsor's protocol ID
- hsd1509
- Status last verified
- Mar 2013
- First submitted
- 24 Apr 2013
- Last updated
- 26 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
de Azevedo JR, Torres OJ, Beraldi RA, Ribas CA, Malafaia O. Prognostic evaluation of severe sepsis and septic shock: procalcitonin clearance vs Delta Sequential Organ Failure Assessment. J Crit Care. 2015 Feb;30(1):219.e9-12. doi: 10.1016/j.jcrc.2014.08.018. Epub 2014 Sep 10.
PubMed 25241933
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROGNOSTIC EVALUATION OF SEVERE SEPSIS AND SEPTIC SHOCK. PROCALCITONIN VERSUS DELTA SOFA
- ClinicalTrials.gov ID
- NCT01841190
- Acronym / sponsor ID
- hsd1509
- Conditions
- Severe Sepsis, Septic Shock
- Keywords
- Prognosis, Sepsis, Septic shock, Procalcitonin, SOFA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Hospital Sao DomingosUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jan 2013 (actual)
- First posted
- 26 Apr 2013 (estimated)
- 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.
The purpose of this study is to compare the tendency of plasma concentration and clearance of procalcitonin in the first 24 and 48 hours of management of patients with severe sepsis and septic shock with another marker of early prognosis represented by 48 hours delta sofa.
Detailed description
This is a cohort prospective observational study that will include adult patients admitted to a multidisciplinary ICU of a tertiary hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PROCALCITONIN | – | – |
| DELTA SOFA | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with severe sepsis and septic shock admitted to a multidisciplinary ICU
Key inclusion criteria (2 listed)
- Adult patients admitted to the ICU
- severe sepsis and septic shock
Key exclusion criteria (2 listed)
- Children
- Pregnant.
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
MORTALITY
Time frame: 28 DAYS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2013.
- Derived from this study: PubMed 25241933de Azevedo JR, Torres OJ, Beraldi RA, Ribas CA, Malafaia O. Prognostic evaluation of severe sepsis and septic shock: procalcitonin clearance vs Delta Sequential Organ Failure Assessment. J Crit Care. 2015 Feb;30(1):219.e9-12. doi: 10.1016/j.jcrc.2014.08.018. Epub 2014 Sep 10.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Sepsis and Septic Shock, run by Hospital Sao Domingos at 2 sites in Brazil.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 26 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JOSE R AZEVEDO, MD (55 98 32168110, jrazevedo@elo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MORTALITY (time frame: 28 DAYS). 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 NCT01841190, which also lists 1 linked publication.
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 26 Apr 2013.