Trial Outcomes & Findings for Utility of Presepsin in Distinguishing Between Sepsis and SIRS (NCT NCT02052895)

NCT ID: NCT02052895

Last Updated: 2018-08-21

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 226 participants
• Primary outcome timeframe: Up to 7 days
• Results posted on: 2018-08-21

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	196	15	15
Overall Study COMPLETED	196	15	15
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Utility of Presepsin in Distinguishing Between Sepsis and SIRS

Baseline characteristics by cohort

Measure	Sepsis/SIRS n=190 Participants Patients with sepsis or SIRS	Control n=15 Participants Patients without SIRS, sepsis, or end stage renal disease	End Stage Renal Disease n=15 Participants Patients with end stage renal disease, without SIRS or sepsis	Total n=220 Participants Total of all reporting groups
Age, Continuous	58.80 years STANDARD_DEVIATION 15.99 • n=5 Participants	65.80 years STANDARD_DEVIATION 13.11 • n=7 Participants	53.70 years STANDARD_DEVIATION 19.5 • n=5 Participants	59.00 years STANDARD_DEVIATION 16.02 • n=4 Participants
Sex: Female, Male Female	73 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants	88 Participants n=4 Participants
Sex: Female, Male Male	117 Participants n=5 Participants	9 Participants n=7 Participants	6 Participants n=5 Participants	132 Participants n=4 Participants

PRIMARY outcome

Timeframe: Up to 7 days

Population: 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

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.

Outcome measures

Measure	Presepsin n=186 Participants ROC-AUC of presepsin for discriminating between Sepsis and SIRS	Procalcitonin n=186 Participants ROC-AUC of procalcitonin for discriminating between Sepsis and SIRS
Area Under the Receiver Operating Characteristic Curve (ROC-AUC) of the Plasma Presepsin Concentration for Discriminating Between SIRS and Sepsis	0.7218 probability Interval 0.6455 to 0.7981	0.6901 probability Interval 0.613 to 0.7672

Adverse Events

Sepsis/SIRS

Serious events: 26 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

End Stage Renal Disease

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Sepsis/SIRS n=190 participants at risk Patients with sepsis or SIRS	Control n=15 participants at risk Patients without SIRS, sepsis, or end stage renal disease	End Stage Renal Disease n=15 participants at risk Patients with end stage renal disease, without SIRS or sepsis
General disorders death	13.7% 26/190 • Number of events 26 Six subjects who didn't meet inclusion/exclusion criteria were not assessed for adverse events.	0.00% 0/15 Six subjects who didn't meet inclusion/exclusion criteria were not assessed for adverse events.	0.00% 0/15 Six subjects who didn't meet inclusion/exclusion criteria were not assessed for adverse events.
Gastrointestinal disorders Gastrointestinal hemmorage	0.53% 1/190 • Number of events 1 Six subjects who didn't meet inclusion/exclusion criteria were not assessed for adverse events.	0.00% 0/15 Six subjects who didn't meet inclusion/exclusion criteria were not assessed for adverse events.	0.00% 0/15 Six subjects who didn't meet inclusion/exclusion criteria were not assessed for adverse events.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.53% 1/190 • Number of events 1 Six subjects who didn't meet inclusion/exclusion criteria were not assessed for adverse events.	0.00% 0/15 Six subjects who didn't meet inclusion/exclusion criteria were not assessed for adverse events.	0.00% 0/15 Six subjects who didn't meet inclusion/exclusion criteria were not assessed for adverse events.
Vascular disorders Hemorrhage	0.53% 1/190 • Number of events 1 Six subjects who didn't meet inclusion/exclusion criteria were not assessed for adverse events.	0.00% 0/15 Six subjects who didn't meet inclusion/exclusion criteria were not assessed for adverse events.	0.00% 0/15 Six subjects who didn't meet inclusion/exclusion criteria were not assessed for adverse events.

Other adverse events

Adverse event data not reported

Additional Information

Hironori Sato

Mochida Pharmaceutical

Phone: +81-3-3225-6331

Email: hnsato@mochida.co.jp

Results disclosure agreements

• Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 50 days from the time submitted to the sponsor for review. Only if the disclosure becomes an obstacle to the sponsor's business or registration or maintenance of the sponsor's invention, the sponsor may require changes to the communication and may extend the embargo.
• Publication restrictions are in place

Restriction type: OTHER