Clinical trial NCT03654287: Exploring and Establishment of Combined Extracorporeal Life Support(CELS) in Critically Ill Children
Official title: Exploring and Establishment of Multiple Organ Support Therapy（CELS）in Critically Ill Children
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Sepsis
Critical Illness
MODS
Keywords: sepsis
CRRT
ECMO
CELS
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: Shanghai Children's Hospital
name: Shanghai Children's Medical Center
name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
First posted: 2018-08-31
Enrollment: 0
Sex: ALL
Minimum age (years): 29
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with severe sepsis and refractory shock admitted to the PICU of four study centers.

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.

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

Primary outcomes:
measure: survival rate
timeFrame: 28 days
Secondary outcomes:
measure: Pediatric Risk of Mortality score （PRISM III）
timeFrame: the first 24 hours after admitted to PICU
measure: ECMO weaning rate
timeFrame: 48 hours
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children'S Hosptial of Fudan University
Study officials:
affiliation: Children's Hospital of Fundan University
name: Guoping LU, doctor
role: PRINCIPAL_INVESTIGATOR
References: