Establishment of Risk Indicators and Early Warning System in Infection Patients

Establishment of Risk Indicators and Early Warning System for Deterioration of Infected Patients in Real-world Data.

Serious infections refer to life-threatening infections with a morbidity and mortality rate of up to 50%, and are the main cause of death in critically ill patients, mainly including systemic inflammatory response syndrome, sepsis, infectious shock, or systemic multiple organ dysfunction syndrome. Patients with severe infections have rapid disease development, which can cause disorders of cellular circulation and metabolism and impairment of multi-organ function in the early stage, mostly accompanied by clinical complications, and despite the progress of medical technology and the popularization of antibiotic application, the mortality and disability rate is high, which is a hot spot of clinical research today. Patients with severe infections are exposed to a wide range of medical risk factors, including patient factors (advanced age, frailty, malnutrition, long hospital stay, prolonged bed rest), disease factors (immune deficiency, malignancy, diabetes, renal failure, liver failure), drug factors (long-term use of steroid hormones, chemotherapeutic drugs, NSAIDs, etc.), interventional factors (central venous catheter, recent invasive surgery, hemodialysis, endotracheal intubation or mechanical ventilation, etc.), which bring great challenges to clinical treatment. Therefore, early identification of risk indicators for deterioration of infected patients provides a strategic basis for the medical team to take early warning measures to prevent deterioration and poor prognosis, and to reduce the risk of deterioration of patients, which is also the key to reduce the risk of death of infected patients.

Study Overview

• Status: Active, not recruiting
• Conditions: Infections

• Study Type: Observational
• Enrollment (Anticipated): 16000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

We integrated pooled individual patient data of infected patients treated at a single center in China from 1 January 2010 until 31 July 2021.

Description

Inclusion Criteria:

• Patients diagnosed with infection

Exclusion Criteria:

• Case information is incomplete
• Do not accept follow-up

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Among patients with infections admitted to the hospital	primary outcome measure were defined as the death.	30 days of hospitalization

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Investigators: Study Director: Jingwen Wang, The First Affiliated Hospital of Air Force Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: October 11, 2021
• First Submitted That Met QC Criteria: October 28, 2021
• First Posted (Actual): October 29, 2021

Study Record Updates

• Last Update Posted (Actual): February 28, 2022
• Last Update Submitted That Met QC Criteria: February 25, 2022
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: Jingwen Wang

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No