Exploring and Establishment of Combined Extracorporeal Life Support(CELS) in Critically Ill Children

NCT03654287 | Withdrawn

• 1 other identifier: fdpicu-02
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Multiple organ failure (MODS) is still the leading cause of death in children in ICU. The treatment of MODS is mainly organ function monitoring and organ replacement therapy. Life support technology in vitro mainly includes mechanical ventilation, continuous renal replacement therapy (CRRT), non-biological artificial liver and extracorporeal membrane oxygenation technology (ECMO). However, critically ill patients who have multiple organ failure often require multiple organ support meanwhile. Combined extracorporeal life support (CELS) is still in its infancy to be applied in the treatment of critical illness due to nonstandard technology and theory without key breakthroughs and evidence-based medicine in the treatment of severe children organ failure.Solving the system problems supported by CELS can effectively reduce the mortality and disability rate of critically ill children and enhance health care in Shanghai, even across China.

Conditions

Sepsis; Critical Illness; MODS

Keywords

sepsis; CRRT; ECMO; CELS

Outcome Measures

Primary Outcomes (1)

• survival rate

  The survival rate of children in 28 days after their hospital discharged.

  28 days

Secondary Outcomes (2)

• Pediatric Risk of Mortality score （PRISM III）

  the first 24 hours after admitted to PICU

• ECMO weaning rate

  48 hours

Study Arms (5)

Treatment with CPFA

The critically ill children who treated by CRRT and CRRT mode is decide as CPFA.

Other: Treatment

Treatment with TPE+CVVHDF

The critically ill children who treated by CRRT and CRRT mode is decide as TPE+CVVHDF.

Other: Treatment

Treatment with CVVHDF

The critically ill children who treated by CRRT and CRRT mode is decide as CVVHDF.

Other: Treatment

Treatment without CRRT/ECMO

The critically ill children who are not treated by CRRT or ECMO.

Treatment with ECMO

The critically ill children who are treated by ECMO whether treated by CRRT

Other: Treatment

Interventions

Treatment OTHER

The CELS way to intervene severe sepsis and refractory shock

Treatment with CPFA; Treatment with CVVHDF; Treatment with ECMO; Treatment with TPE+CVVHDF

Eligibility Criteria

• Age: 29 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 severe sepsis and refractory shock admitted to the PICU of four study centers.

You may qualify if:

• Children with severe sepsis and refractory shock admitted to the PICU of four study centers.
• The informed consent of the guardians

You may not qualify if:

• active hemorrhage difficult catheter placing Irreversible brain damage patients enrolled in other clinic trial

Sponsors & Collaborators

• Guoping Lu: 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 Hosptial of Fudan University

Shanghai, China

Location

MeSH Terms

Conditions

Sepsis; Critical Illness; Multiple Organ Failure

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

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

Study Officials

• Guoping LU, doctor

  Children's Hospital of Fundan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of pediatric Emergency and Critical Care Center. Children's Hospital Fudan University;Director of AHA Training Center for pediatric life support. Children's Hospital Fudan University

Study Record Dates

• First Submitted: August 29, 2018
• First Posted: August 31, 2018
• Study Start: October 30, 2018
• Primary Completion: October 30, 2020
• Study Completion: October 30, 2021
• Last Updated: May 8, 2019

Record last verified: 2019-05

Locations

CN (1)