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

Withdrawn

• Conditions: Critical Illness; MODS; Sepsis
• Interventions: Other: Treatment

• Registration Number: NCT03654287
• Lead Sponsor: Guoping Lu

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.

Study Timeline

• Study First Submitted: 2018-08-29
• Study First Submitted QC: 2018-08-29
• Study First Posted: 2018-08-31
• Study Start: 2018-10-30
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-06
• Last Update Posted: 2019-05-08
• Primary Completion: 2020-10-30
• Study Completion: 2021-10-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment with CPFA	Treatment	The critically ill children who treated by CRRT and CRRT mode is decide as CPFA.
Treatment with ECMO	Treatment	The critically ill children who are treated by ECMO whether treated by CRRT
Treatment with TPE+CVVHDF	Treatment	The critically ill children who treated by CRRT and CRRT mode is decide as TPE+CVVHDF.
Treatment with CVVHDF	Treatment	The critically ill children who treated by CRRT and CRRT mode is decide as CVVHDF.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
ECMO weaning rate	48 hours	The success of ECMO weaning is defined as the survival of patients after ECMO is wean for 48 hours
Pediatric Risk of Mortality score （PRISM III）	the first 24 hours after admitted to PICU	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 .

Trial Locations

Locations (1)

Children'S Hosptial of Fudan University; 🇨🇳 Shanghai, China