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

Sepsis Clinical Trial

— CELS  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03654287
• Other study ID #: fdpicu-02
• Status: Withdrawn
• Start date: October 30, 2018
• Est. completion date: October 30, 2021

Study information

• Verified date: May 2019
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 30, 2021
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• MODS
• Sepsis

Intervention

Other:
• Treatment
The CELS way to intervene severe sepsis and refractory shock

Locations

Country	Name	City	State
China	Children'S Hosptial of Fudan University	Shanghai

Sponsors (4)

Lead Sponsor	Collaborator
Guoping Lu	Shanghai Children's Hospital, Shanghai Children's Medical Center, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survival rate	The survival rate of children in 28 days after their hospital discharged.	28 days
Secondary	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
Secondary	ECMO weaning rate	The success of ECMO weaning is defined as the survival of patients after ECMO is wean for 48 hours	48 hours