Clinical Trials Logo
  1. Home
  2. Sepsis
  3. NCT05383963
  4. Details
NCT05383963 Clinical Trial

Evaluation of Parameters Collected From Routine Data for the Diagnosis of Sepsis and Septic Shock and Their Influence on Time to Diagnosis and Patient Outcome

Sepsis Clinical Trial

Official title:
Evaluation of Parameters Collected From Routine Data for the Diagnosis of Sepsis and Septic Shock and Their Influence on Time to Diagnosis and Patient Outcome (QUICK-SEPSIS)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05383963
Other study ID # QUICK-SEPSIS
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 15, 2022
Est. completion date December 2027

Study information
Verified date January 2024
Source Charite University, Berlin, Germany
Contact Claudia Spies, MD, Prof.
Phone +49 30 450 55 11 02
Email claudia.spies@charite.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Retrospective observational study to develop a Machine Learning Algorithm to evaluate parameters collected from routine data for the diagnosis of sepsis and septic shock and their influence on time to diagnosis and patient outcome.

Description:

Retrospective routine data from the medical records of the department of anesthesiology and operative intensive care from 01. 01. 2007 to 31. 12. 2021 are analyzed in digital form. The first step is the development of a machine learning algorithm (MLA). This MLA will be validated and analyzed for his predictive value with regard to early diagnosis of sepsis/septic shock depending on the conceptual value of detection variables (Sepsis-3 vs. SIRS). Further analysis will focus on improvement of accuracy for the MLA and the effect of these detection variables on quality of treatment processes and also on economic consequences like cost and revenue. Timeline: 1. Conception and development of the ML Algorithm (6 months) 2. Identification and diagnostic validation of sepsis patients (6 months) 3. Secondary analyses (36 months)

Recruitment information / eligibility
Status Recruiting
Enrollment 10000
Est. completion date December 2027
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - age >= 18 years - ICU stay of > 24 hours Exclusion Criteria: - none

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Department of Anesthesiology and Operative Intensive Care Medicine CCM/CVK, Charité - Universitätsmedizin Berlin Berlin

Sponsors (1)
Lead Sponsor Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sepsis/septic shock Development of a machine learning algorithm (MLA) for the prediction of sepsis/septic shock from hospital routine data. 01.01.2007 -31.12.2021
Secondary Predictive accuracy Evaluation of the predictive accuracy (= predictive value) of the respective sepsis diagnostic algorithm (i.e. comparison of the concepts SIRS and Sepsis-3) 01.01.2007 -31.12.2021
Secondary Diagnostic accuracy Identification of additional variables for diagnostic accuracy (laboratory values, clinical parameters and vital-sign monitor parameters and other relevant health data 01.01.2007 -31.12.2021
Secondary Performance indicators Evaluation of performance indicators of clinical routine processes (Intensive care quality indicators) 01.01.2007 -31.12.2021
Secondary Case costs Case costs related to hospitalization 01.01.2007 -31.12.2021
Secondary Revenues Revenues related to hospitalization 01.01.2007 -31.12.2021
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05095324 - The Biomarker Prediction Model of Septic Risk in Infected Patients
Completed NCT02714595 - Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens Phase 3
Completed NCT03644030 - Phase Angle, Lean Body Mass Index and Tissue Edema and Immediate Outcome of Cardiac Surgery Patients
Completed NCT02867267 - The Efficacy and Safety of Ta1 for Sepsis Phase 3
Completed NCT04804306 - Sepsis Post Market Clinical Utility Simple Endpoint Study - HUMC
Recruiting NCT05578196 - Fecal Microbial Transplantation in Critically Ill Patients With Severe Infections. N/A
Terminated NCT04117568 - The Role of Emergency Neutrophils and Glycans in Postoperative and Septic Patients
Completed NCT03550794 - Thiamine as a Renal Protective Agent in Septic Shock Phase 2
Completed NCT04332861 - Evaluation of Infection in Obstructing Urolithiasis
Completed NCT04227652 - Control of Fever in Septic Patients N/A
Enrolling by invitation NCT05052203 - Researching the Effects of Sepsis on Quality Of Life, Vitality, Epigenome and Gene Expression During RecoverY From Sepsis
Terminated NCT03335124 - The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock Phase 4
Recruiting NCT04005001 - Machine Learning Sepsis Alert Notification Using Clinical Data Phase 2
Completed NCT03258684 - Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Sepsis and Septic Shock N/A
Recruiting NCT05217836 - Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.
Completed NCT05018546 - Safety and Efficacy of Different Irrigation System in Retrograde Intrarenal Surgery N/A
Completed NCT03295825 - Heparin Binding Protein in Early Sepsis Diagnosis N/A
Not yet recruiting NCT06045130 - PUFAs in Preterm Infants
Not yet recruiting NCT05361135 - 18-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in S. Aureus Bacteraemia N/A
Not yet recruiting NCT05443854 - Impact of Aminoglycosides-based Antibiotics Combination and Protective Isolation on Outcomes in Critically-ill Neutropenic Patients With Sepsis: (Combination-Lock01) Phase 3