Clinical Features and Outcomes of CBP Versus Non-CBP in Septic Children

Sepsis Clinical Trial

Official title:

Clinical Features and Outcomes of Continuous Blood Purification Versus Non-continuous Blood Purification in Pediatric Patients With Sepsis or Septic Shock

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04794595
• Other study ID #: fdpicu-08
• Status: Recruiting
• Start date: December 1, 2020
• Est. completion date: December 30, 2024

Study information

• Verified date: February 2024
• Source: Children's Hospital of Fudan University
• Contact: YING JIAYUN
• Phone: 18817583962
• Email: jiayundoctor[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The effect of continuous blood purification (CBP) in children is unclear. Also, the timing of early application is still being explored. In this study, we need to explore the efficacy and the timing of application of CBP in children with sepsis or septic shock.

Description:

Early intervention of CBP can remove inflammatory factors in patients with sepsis and reduce the damage of inflammatory factors to organs; at the same time, it can also promote the body's immune response, significantly improve immune dysfunction, and restore the body's immune balance. However, the timing of early application of CBP in childhood sepsis is still unclear. Therefore, it is necessary to further explore the treatment and prognosis of this technology in the early treatment of sepsis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Days to 18 Years

Eligibility

Inclusion Criteria:

• Age of 29d to 18 years old;

• Children diagnosed with sepsis requiring blood purification.

Exclusion Criteria:

• with a history of a duration of PICU stay <24 h

• active bleeding, including cerebral hemorrhage

Related Conditions & MeSH terms

• Children, Only
• Sepsis

Intervention

Procedure:
• CBP
continuous blood purification can prevent or treat fluid overload in children with septic shock or other sepsis-associated organ dysfunction who are unresponsive to fluid restriction and diuretic therapy management of septic AKI patients, particularly those with hemodynamic instability or fluid overload. Also, it can remove cytokines

Locations

Country	Name	City	State
China	Children'S Hospital of Fudan University	Shanghai	Shanghai

Sponsors (4)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University	Shanghai Children's Hospital, Shanghai Children's Medical Center, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survival rate	The survival rate of children in 28 days after hospital discharge	28 days after hospital discharge
Secondary	The creatinine level of non-survival children with sepsis	The creatinine level of non-survival children with sepsis in 28 days after hospital discharge	28 days after hospital discharge