A Prediction Model of 28-day Mortality in Septic Shock

NCT04915625 | Unknown

• 1 other identifier: 2021-0603
• Study Type: observational
• Target: 530
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Septic Shock

Keywords

mortality; Predictive model

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• ICU hospitalization time

  2 years

• hospitalization mortality

  2 years

Study Arms (2)

Death group

Retrospective observational studies

Survival group

Retrospective observational studies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Sepsis shock patients admitted to our hospital

You may qualify if:

• Age ≥ 18 years of age, gender-neutral;
• Diagnosed with sepsis shock;
• ICU survives longer than 48 h;
• The preservation of clinical data is complete;

You may not qualify if:

• \- 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;

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hanzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• ZHIJUN XU, MS

  2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MAN HUANG, MD PHD

CONTACT

+86 13906518699; huangman@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: June 7, 2021
• Study Start: December 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: June 7, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)