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

Exploring and Establishment of Multiple Organ Support Therapy（CELS）in Critically Ill Children

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.

Study Overview

• Status: Withdrawn
• Conditions: Sepsis; Critical Illness; MODS
• Intervention / Treatment: Other: Treatment

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Children's hosptial of fudan university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 weeks to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treatment with CPFA; The critically ill children who treated by CRRT and CRRT mode is decide as CPFA.	Other: Treatment; 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.	Other: Treatment; 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.	Other: Treatment; 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.
Treatment with ECMO; The critically ill children who are treated by ECMO whether treated by CRRT	Other: Treatment; The CELS way to intervene severe sepsis and refractory shock

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
survival rate	The survival rate of children in 28 days after their hospital discharged.	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pediatric Risk of Mortality score （PRISM III）	The PRISM score is a quantification of physiologic status using predetermined physiologic variables and their ranges that use categorical variables to facilitate accurate estimation of mortality risk.The PRISM components were separated into cardiovascular (heart rate, systolic blood pressure, and temperature), neurologic ( pupillary reactivity and mental status), respiratory (arterial Po2, pH, Pco2, and total bicarbonate), chemical (glucose, potassium, blood urea nitrogen, and creatinine), and hematologic (WBC count, platelet count, prothrombin, and partial thromboplastin time) component.The score above 10 indicates a poor prognosis and higher mortality of critical ill children. The score below 10 indicates a relatively favorable prognosis and lower mortality .	the first 24 hours after admitted to PICU
ECMO weaning rate	The success of ECMO weaning is defined as the survival of patients after ECMO is wean for 48 hours	48 hours

Collaborators and Investigators

• Sponsor: Guoping Lu
• Collaborators: Shanghai Children's Hospital; Shanghai Children's Medical Center; Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Investigators: Principal Investigator: Guoping Lu, doctor, Children's hospital of Fundan University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 30, 2018
• Primary Completion (Anticipated): October 30, 2020
• Study Completion (Anticipated): October 30, 2021

Study Registration Dates

• First Submitted: August 29, 2018
• First Submitted That Met QC Criteria: August 29, 2018
• First Posted (Actual): August 31, 2018

Study Record Updates

• Last Update Posted (Actual): May 8, 2019
• Last Update Submitted That Met QC Criteria: May 6, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: ECMO; sepsis; CRRT; CELS
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: fdpicu-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No