SEPSys and RESCUE Scores for Sepsis Prediction

Recruiting at 7 trial locations

Overseen By Jason Heavner, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Disqualifiers: Pediatric, Psychiatric, Sepsis, High RESCUE, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

150000 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment RESCUE Score, UMMS Sepsis Early Prediction Score (SEPSys) for sepsis prediction?

The research highlights the development and validation of various scoring systems that improve the prediction of outcomes in sepsis patients, suggesting that similar tools like the RESCUE Score and SEPSys could be effective in predicting sepsis outcomes by using key health indicators. ^{1 2 3 4 5}

Is the SEPSys and RESCUE Scores treatment safe for humans?

The research articles focus on the development and validation of scoring systems for predicting outcomes in sepsis patients, but they do not provide specific safety data for the SEPSys and RESCUE Scores treatment in humans. ^{6 7 8 9 10}

How does the SEPSys and RESCUE Scores treatment for sepsis differ from other treatments?

The SEPSys and RESCUE Scores treatment is unique because it focuses on using scoring systems to predict and manage sepsis, rather than directly treating the condition with medication. This approach aims to improve early recognition and prognosis by systematically assessing the severity of the condition, which is different from traditional treatments that primarily focus on addressing the infection and its symptoms. ^{9 11 12 13 14}

What is the purpose of this trial?

This study is designed to test two new risk scores - one designed to predict a patient's four-hour risk of developing sepsis and one designed to predict a patient's four-hour risk of deterioration (cardiac arrest, death, unplanned ICU transfer, or rapid response team call). The goal of this study is to improve provider awareness of a patient's risk of these two negative outcomes by providing them with new risk scores. The primary outcome will be the time from when the risk score becomes elevated to when vital signs such as heart rate or blood pressure are measured, suggesting an increased awareness.

Eligibility Criteria

This trial is for patients at risk of sepsis or sudden health decline, including conditions like umbilical sepsis and pre-eclampsia. Specific inclusion and exclusion criteria are not detailed here.

Inclusion Criteria

Additional RESCUE Encounter Inclusion Criteria: Encounter has a RESCUE Score

Hospital Unit Inclusion Criteria: Units are part of a member hospital of the University of Maryland Medical System (UMMS)

Units agree to participate in the study

Exclusion Criteria

Additional RESCUE Encounter Exclusion Criteria: Encounter is admitted with a high RESCUE Score (RESCUE Score of 4)

My treatment center focuses on children under 18.

I was admitted to the hospital with sepsis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Hospitals operate without SEPSys or RESCUE Scores to establish baseline data

Varies

Intervention

Hospitals are randomized to receive either SEPSys or RESCUE Score, followed by both scores

Several months

Follow-up

Participants are monitored for safety and effectiveness after intervention

Up to 24 hours post-elevation of risk scores

Treatment Details

Interventions

• RESCUE Score
• UMMS Sepsis Early Prediction Score (SEPSys)

Trial Overview The study tests two new scores: SEPSys predicts the four-hour risk of developing sepsis, while RESCUE predicts the same timeframe risk of deterioration (like cardiac arrest). It aims to alert healthcare providers early.

Participant Groups

Group I: SEPSys+RESCUE Experimental Treatment 2 Interventions

Cluster has both SEPSys \& RESCUE Scores

Group II: SEPSys Experimental Treatment 1 Intervention

Cluster has SEPSys Score only

Group III: RESCUE Experimental Treatment 1 Intervention

Cluster has RESCUE Score only

Group IV: Baseline Active Control 1 Intervention

Cluster has neither SEPSys nor RESCUE

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

University of Maryland Medical System

Collaborator

Trials

2

Recruited

150,000+

References

1. China pubmed.ncbi.nlm.nih.gov

[Comparison of simplified acute physiology score III and other scoring systems in prediction of 28-day prognosis in patients with severe sepsis]. [2018]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Development and Validation of a Rapid and Efficient Prognostic Scoring System for Sepsis Based on Oxygenation Index, Lactate and Glasgow Coma Scale. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Development and validation of a clinical score combining the sequential organ failure assessment score with inflammation-based markers to predict outcome of patients with sepsis. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Construction and dual internal validation of a short-term prognostic scoring tool for sepsis. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Supervised classification techniques for prediction of mortality in adult patients with sepsis. [2021]

6. China pubmed.ncbi.nlm.nih.gov

Establishment of a novel risk score for in-hospital mortality in adult sepsis patients. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Implementation of a Modified Neonatal Early-onset Sepsis Calculator in Well-baby Nursery: a Quality Improvement Study. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

The Effect of the Intelligent Sepsis Management System on Outcomes among Patients with Sepsis and Septic Shock Diagnosed According to the Sepsis-3 Definition in the Emergency Department. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Prognostic value of serial score measurements of the national early warning score, the quick sequential organ failure assessment and the systemic inflammatory response syndrome to predict clinical outcome in early sepsis. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Errors and bias in using predictive scoring systems. [2023]

11. Italy pubmed.ncbi.nlm.nih.gov

Evaluation of the modified MEDS, MEWS score and Charlson comorbidity index in patients with community acquired sepsis in the emergency department. [2022]

12. Austria pubmed.ncbi.nlm.nih.gov

Severity illness scoring systems for early identification and prediction of in-hospital mortality in patients with suspected sepsis presenting to the emergency department. [2022]

13. India pubmed.ncbi.nlm.nih.gov

Comparative Study of Sofa, Apache Ii, Saps Ii, as a Predictor of Mortality in Patients of Sepsis Admitted in Medical ICU. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

The Modified Early Warning Score: A Useful Marker of Neurological Worsening but Unreliable Predictor of Sepsis in the Neurocritically Ill-A Retrospective Cohort Study. [2021]