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

NCT04794595 | Recruiting

• 1 other identifier: fdpicu-08
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sepsis; Children, Only

Keywords

Continuous renal replacement therapy; sepsis; timing

Outcome Measures

Primary Outcomes (1)

• survival rate

  The survival rate of children in 28 days after hospital discharge

  28 days after hospital discharge

Secondary Outcomes (1)

• The creatinine level of non-survival children with sepsis

  28 days after hospital discharge

Study Arms (2)

sepsis group with CBP

The child with sepsis should be treated with CBP， but could not receive this treatment for various reasons

Procedure: CBP

sepsis group without CBP

The child with sepsis should be treated with CBP and received this treatment

Interventions

CBP PROCEDURE

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

Also known as: traditional therapy

sepsis group with CBP

Eligibility Criteria

• Age: 28 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

children with sepsis requiring blood purification to prevent or treat fluid overload or to clear cytokines

You may qualify if:

• Age of 29d to 18 years old;
• Children diagnosed with sepsis requiring blood purification.

You may not qualify if:

• with a history of a duration of PICU stay \<24 h
• active bleeding, including cerebral hemorrhage

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead
• Shanghai Children's Hospital: collaborator
• Shanghai Children's Medical Center: collaborator
• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: collaborator

Study Sites (1)

Children'S Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

the volume of 2ml whole blood was stored in EDTA tube

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

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

Study Officials

• Lu guoing

  Children's Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

YING JIAYUN

CONTACT

18817583962; jiayundoctor@163.com

Study Design

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

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 12, 2021
• Study Start: December 1, 2020
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

CN (1)