An observational study in Sepsis, sponsored by PMD Solutions. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-23.
Sponsored by PMD Solutions · Observational
The primary objective is to determine if the trend in Respiratory Rate measurements provided by the device under investigation can be used to predict an increase in Sequential/Sepsis-related Organ Failure Assessment (SOFA) score.
The RR trend will be measured as the difference between the RR recorded by the device at a point 15 minutes after commencement of treatment, as per the standard of care for patients suspected of being septic, and a point 3 hours following this.
The primary objective is to determine if the trend in Respiratory Rate measurements provided by the device under investigation can be used to predict an increase in Sequential/Sepsis-related Organ Failure Assessment (SOFA) score.
The RR trend will be measured as the difference between the RR recorded by the device at a point 15 minutes after commencement of treatment, as per the standard of care for patients suspected of being septic, and a point 3 hours following this.
Secondary objective The secondary objective is to test if Respiratory Rate can help identify patients at increased risk of 30 day mortality.
The null Hypotheses of the planned comparison is that there is no difference in the RR trend in the 3 hours following commencement of treatment for sepsis in subjects who have an increase in SOFA score by 2 or more points and those who have a change in SOFA score of +1 or less.
The change in SOFA score will be measured at point of commencement of treatment and at 6 hours following commencement of treatment, or nearest available SOFA score determination.
Respiratory Rate captured during admission could have a predictive course for cohort of interest
The time points for reviewing the RR will be as follows:
(i) The last measurement (ii) The trend over 3 hours following commencement of treatment as per the standard of care for patients suspected of being septic.
(iii) The trend over the entire duration of admission
For this investigation, the population of interest are patients admitted to the Acute Medical Unit (AMU) with sepsis or that develop sepsis during their admission.
Sepsis diagnosis confirmed by documented or suspected infection (ordering of blood culture or other microbiological investigation by the clinician) and ≥1 of the following presenting within the first 4 hours of admission:
Exclusion criteria
Patients who are admitted and are diagnosed with sepsis will be recruited for this investigation.
RespiraSense triggered escalation in SOFA score
Escalation of SOFA score by 2 or more points. The primary endpoint will be evaluated with an ANCOVA with escalation of SOFA score by 2 or more points as a factor and mean RR in the first hour of treatment as a covariate.
Time frame: 15 minutes after commencement of treatment, as per the standard of care for patients suspected of being septic, and a point 3 hours following this.
Upward trend in Respiratory Rate as a predictor of 30 day mortality
The secondary endpoint is the 30 day mortality rate after discharge.
Time frame: 30 days after discharge
Upward trend in Respiratory Rate as a predictor of 30 day readmission.
The secondary endpoint is the 30 day readmission rate after discharge.
Time frame: 30 days after discharge
Plan to share: Undecided — Data can be shared upon request.
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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