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

NCT ID: NCT03654287

Last Updated: 2019-05-08

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-30
• Study Completion Date: 2021-10-30

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.

Detailed Description

The whole study is described below. To investigate the timing ,curative effect and mode of CRRT and ECMO treatment for critically ill children,we choose sepsis children especially those who are combined with septic shock as research object.

Furthermore,refractory shock is the therapeutic indications of ECMO. According to their clinical manifestation and severity of the disease,they are treated by CRRT or/with ECMO in a non-randomized way.

Comparing the laboratory index and prognosis of critically ill children treated by CRRT and those treated by ECMO,we aim to investigate the the timing ,curative effect of ECMO in the treatment of septic shock especially refractory shock.

The critically ill children who treated by CRRT are divided into three groups according to their treatment mode of CRRT. The laboratory index and prognosis are also be compared to investigate curative effect of CRRT in the treatment of septic shock.

The study also include severe sepsis children without CRRT or ECMO treatment as a control group.

Conditions

Sepsis; Critical Illness; MODS

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Treatment with CPFA

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

Treatment

Intervention Type: OTHER

The CELS way to intervene severe sepsis and refractory shock

Treatment with TPE+CVVHDF

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

Treatment

Intervention Type: OTHER

The CELS way to intervene severe sepsis and refractory shock

Treatment with CVVHDF

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

Treatment

Intervention Type: OTHER

The CELS way to intervene severe sepsis and refractory shock

Treatment without CRRT/ECMO

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

No interventions assigned to this group

Treatment with ECMO

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

Treatment

Intervention Type: OTHER

The CELS way to intervene severe sepsis and refractory shock

Interventions

Treatment

The CELS way to intervene severe sepsis and refractory shock

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

The informed consent of the guardians

Exclusion Criteria

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

• Minimum Eligible Age: 29 Days
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Children's Hospital

OTHER

Sponsor Role: collaborator

Shanghai Children's Medical Center

OTHER

Sponsor Role: collaborator

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: collaborator

Guoping Lu

OTHER

Sponsor Role: lead

Responsible Party

Guoping Lu

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

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Guoping LU, doctor

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Fundan University

Locations

Children'S Hosptial of Fudan University

Shanghai, , China

Countries

China

Other Identifiers

fdpicu-02

Identifier Type: -

Identifier Source: org_study_id