SIRSNCT02052895

Utility of Presepsin in Distinguishing Between Sepsis and SIRS

An observational study of SIRS and Sepsis, run by Mochida Pharmaceutical Company, Ltd. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is an observational study to evaluate the diagnostic accuracy of presepsin levels to discriminate between sepsis and SIRS upon presentation with critical illness compatible with either sepsis or systemic inflammatory response syndrome (SIRS). Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: SIRS, Sepsis
How many people: 226 participants
Where: 2 sitesUnited States
Study dates: Jan 2014to Jul 2015
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Subjects with presentation to ICU with critical illness compatible with either sepsis or systemic inflammatory response syndrome (SIRS).

Who may be able to join

Male or female aged ≥ 21 years
Appropriate clinical data to enable classification into sepsis or SIRS
Written informed consent by the patient or legally authorized representative
Critical illness consistent with SIRS or sepsis, to be enrolled within 18 hours of presentation
Male or female aged ≥ 21 years
Does not meet clinical criteria for sepsis or SIRS

Show all 11Show fewer

Written informed consent by the patient or legally authorized representative
Male or female aged ≥ 21 years
Documented diagnosis of end stage renal disease currently undergoing dialysis
Does not meet clinical criteria for sepsis or SIRS
Written informed consent by the patient or legally authorized representative

Who cannot join

No informed consent
Unacceptable risk imposed by extra blood sampling, such as by gross hemorrhage with a hematocrit < 20%
Control
No informed consent
Unacceptable risk imposed by extra blood sampling, such as by gross hemorrhage with a hematocrit < 20%
End Stage Renal Disease
No informed consent
Unacceptable risk imposed by extra blood sampling, such as by gross hemorrhage with a hematocrit < 20%

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Lahey Clinic
Boston, Massachusetts, 01805
Tufts Medical Center
Boston, Massachusetts, 02111

Other trials in United States

About this study

Official title: Utility of Presepsin in Distinguishing Between Sepsis and SIRS (Systemic Inflammatory Response Syndrome): an Exploratory, Prospective Observational Study in Critically Ill Patients

Conditions: SIRS, Sepsis
Keywords: Presepsin, Sepsis, SIRS
Medical subject headings: Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02052895
Study group	Role	What they receive
Sepsis/SIRS		Patients with sepsis or SIRS
Control		Patients without SIRS, sepsis, or end stage renal disease
End Stage Renal Disease		Patients with end stage renal disease, without SIRS or sepsis

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Receiver Operating Characteristic Curve (ROC-AUC) of the Plasma Presepsin Concentration for Discriminating Between SIRS and Sepsis
For the analysis, plasma presepsin levels on Day 0 were used and Sepsis/SIRS adjudication was made on Day 7 or day of discharge. ROC-AUC of presepsin for discriminating between SIRS and sepsis is compared to that of procalcitonin.
Measured: Up to 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2014Jul 2015

First posted3 Feb 2014 (estimated)
Study startJan 2014
Primary completionJul 2015
Study completionJul 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SIRSStudies 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: 226 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02052895
Sponsor's protocol ID: IVD2001
Status last verified: Aug 2018
First submitted: 30 Jan 2014
Last updated: 21 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Active, not recruitingPhase 4
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All SIRS trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Utility of Presepsin in Distinguishing Between Sepsis and SIRS (Systemic Inflammatory Response Syndrome): an Exploratory, Prospective Observational Study in Critically Ill Patients
ClinicalTrials.gov ID: NCT02052895
Acronym / sponsor ID: IVD2001
Conditions: SIRS, Sepsis
Keywords: Presepsin, Sepsis, SIRS
Study type: Observational
Recruitment status: Completed
Enrolment: 226 participants (actual)
Lead sponsor: Mochida Pharmaceutical Company, Ltd.Industry (pharma, biotech, devices)
Study start: Jan 2014
Primary completion: Jul 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 3 Feb 2014 (estimated)
Results: Posted 27 Sep 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
Sepsis/SIRS	–	–Patients with sepsis or SIRS
Control	–	–Patients without SIRS, sepsis, or end stage renal disease
End Stage Renal Disease	–	–Patients with end stage renal disease, without SIRS or sepsis

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Subjects with presentation to ICU with critical illness compatible with either sepsis or systemic inflammatory response syndrome (SIRS).

Key inclusion criteria (11 listed)

Male or female aged ≥ 21 years
Appropriate clinical data to enable classification into sepsis or SIRS
Written informed consent by the patient or legally authorized representative
Critical illness consistent with SIRS or sepsis, to be enrolled within 18 hours of presentation
Male or female aged ≥ 21 years

Key exclusion criteria (8 listed)

No informed consent
Unacceptable risk imposed by extra blood sampling, such as by gross hemorrhage with a hematocrit < 20%
Control
No informed consent
Unacceptable risk imposed by extra blood sampling, such as by gross hemorrhage with a hematocrit < 20%

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

Area Under the Receiver Operating Characteristic Curve (ROC-AUC) of the Plasma Presepsin Concentration for Discriminating Between SIRS and Sepsis
Time frame: Up to 7 days
For the analysis, plasma presepsin levels on Day 0 were used and Sepsis/SIRS adjudication was made on Day 7 or day of discharge. ROC-AUC of presepsin for discriminating between SIRS and sepsis is compared to that of procalcitonin.

Results and safety

Results posted to the registry on 27 Sep 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sepsis/SIRS	196	196
Control	15	15
End Stage Renal Disease	15	15

Primary outcome: Area Under the Receiver Operating Characteristic Curve (ROC-AUC) of the Plasma Presepsin Concentration for Discriminating Between SIRS and Sepsis

Time frame: Up to 7 days. Least squares mean (95% Confidence Interval). Unit: probability

Measure	Presepsin n = 186	Procalcitonin n = 186
Value	0.7218 (0.6455 to 0.7981)	0.6901 (0.6130 to 0.7672)

Presepsin vs Procalcitonin: Difference of ROC-AUC: 0.0317 (95% CI -0.0409 to 0.1043), p = 0.3924, Regression, Logistic

Population analysed: Out of 196 Sepsis/SIRS patients, 6 were excluded due to inclusion/exclusion criteria violation and 4 were excluded due to insufficient data for Sepsis/SIRS adjudication

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sepsis/SIRS	26 of 190 (13.7%)	0 of 190 (0%)	Not reported
Control	0 of 15 (0%)	0 of 15 (0%)	Not reported
End Stage Renal Disease	0 of 15 (0%)	0 of 15 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for SIRS

Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock

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.

Stanley Nasraway, MD, FCCM principal investigator

Tufts Medical Center

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 SIRS and Sepsis, run by Mochida Pharmaceutical Company, Ltd. at 2 sites in United States.

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 11 inclusion and 8 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 21 Aug 2018. 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 United States. 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?

Yes. Results are posted in the registry (first posted 27 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Area Under the Receiver Operating Characteristic Curve (ROC-AUC) of the Plasma Presepsin Concentration for Discriminating Between SIRS and Sepsis (time frame: Up to 7 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 NCT02052895.

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 21 Aug 2018.