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The Early Prediction of Sepsis in ICU

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05088850
Recruitment Status : Recruiting
First Posted : October 22, 2021
Last Update Posted : October 22, 2021
Sponsor:
Information provided by (Responsible Party):
lei li, Ruijin Hospital

Brief Summary:
Sepsis is a vital issue in critical care medicine, and early detection and intervention are key to survival. We aimed to establish an early warning system for sepsis based on a data integration platform that can be implemented in the ICU.

Condition or disease Intervention/treatment
Prediction of Sepsis in Critical Patients Other: no intervention

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Early Prediction of Sepsis Occurrence in ICU
Actual Study Start Date : May 30, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Group/Cohort Intervention/treatment
non-sepsis Other: no intervention
no intervention

sepsis Other: no intervention
no intervention




Primary Outcome Measures :
  1. confidence index of sepsis occurrence [ Time Frame: sepsis occurrence in five hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients that were admitted into the ICU.
Criteria

Inclusion Criteria:

Patients who met all of the following criteria were included in the case group:

  1. At least 14 years old.
  2. Sepsis onset at least 5 hours after ICU admission.
  3. Sepsis onset is the first instance since admission to the hospital.

Exclusion Criteria:

Patients meeting all of the following criteria were included in the control group:

  1. At least 14 years old.
  2. Patients staying in ICU for at least 5 hours and have not had sepsis in this time.
  3. Patients without ICD-9 codes for sepsis (785·52, 995·91, 995·92).
  4. SOFA score change is not more than 1 point in an arbitrary continuous 72 hours in the ICU stay.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05088850


Contacts
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Contact: Ranran Li, PhD 18317059746 rebecca1009@hotmail.com

Locations
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China, Shanghai
ICU, Ruijin Hospital Recruiting
Shanghai, Shanghai, China, 200025
Contact: Ranran Li, PhD    18317059746    rebecca1009@hotmail.com   
Sponsors and Collaborators
Ruijin Hospital
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Responsible Party: lei li, chief physician, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT05088850    
Other Study ID Numbers: 20211014LILEI
First Posted: October 22, 2021    Key Record Dates
Last Update Posted: October 22, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sepsis
Toxemia
Infections
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes