A Prediction Model of 28-day Mortality in Septic Shock

Septic Shock Clinical Trial

Official title:

A Prediction Model of 28-day Mortality in Septic Shock

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04915625
• Other study ID #: 2021-0603
• Status: Recruiting
• Start date: December 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: June 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: MAN HUANG, MD PHD
• Phone: +86 13906518699
• Email: huangman[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This clinical study adopts the design of cohort research, selects the sepsis shock patients admitted to our hospital ICU as the research object, takes the 28-day mortality rate as the outcome index, collects the baseline data of the patient, the severity of the disease, vital signs, the main infection site, the laboratory-related index, the treatment method and other data, screens out the risk factors affecting the sepsis shock 28-day mortality rate and constructs the prediction model accordingly, analyzes the prediction model with the subject's working characteristic curve (ROC). The recognition ability of the model is calculated by the area under the ROC curve (AUC) and the ability of the model to predict 28-day mortality with SOFA and APACHE II.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 530
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age = 18 years of age, gender-neutral;

2. Diagnosed with sepsis shock;

3. ICU survives longer than 48 h;

4. The preservation of clinical data is complete;

Exclusion Criteria:

• Diagnosed with sepsis shock within 6 hours of emergency treatment; Combined with people with autoimmune diseases; 3. Organ transplantation or immunosuppressive treatment; 4. Severe heart, liver and kidney insufficiency; 5. Late stage of malignant tumor; 6. Maternity; 7. Referral or referral to another hospital;

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Locations

Country	Name	City	State
China	2nd Affiliated Hospital, School of Medicine, Zhejiang University, China	Hanzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All causes of 28 days mortality	The all-cause mortality rate is measured from the time the ICU is admitted to the hospital and 28 days after admission (regardless of ICU, hospitalization or out-of-hospital mortality).	28 days
Secondary	ICU hospitalization time	hospitalization time	2 years
Secondary	hospitalization mortality		2 years