SepsisCELSNCT03654287
Exploring and Establishment of Combined Extracorporeal Life Support(CELS) in Critically Ill Children
An observational study of Sepsis and Critical Illness, run by Guoping Lu at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 29 days to 18 years
- Conditions the study is for
- Sepsis, Critical Illness, MODS
- What is being tested?
- Treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2018to 30 Oct 2021
- How long will I take part?
- 28 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 29 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with severe sepsis and refractory shock admitted to the PICU of four study centers.
Who may be able to join
- Children with severe sepsis and refractory shock admitted to the PICU of four study centers.
- The informed consent of the guardians
Who cannot join
- active hemorrhage difficult catheter placing Irreversible brain damage patients enrolled in other clinic trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Treatment
- Keywords
- sepsis, CRRT, ECMO, CELS
- Medical subject headings
- Sepsis, Critical Illness, Multiple Organ Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreatmentOther
The CELS way to intervene severe sepsis and refractory shock
| Study group | Role | What they receive |
|---|---|---|
| Treatment with CPFA | The critically ill children who treated by CRRT and CRRT mode is decide as CPFA. Receives: Other: Treatment | |
| Treatment with TPE+CVVHDF | The critically ill children who treated by CRRT and CRRT mode is decide as TPE+CVVHDF. Receives: Other: Treatment | |
| Treatment with CVVHDF | The critically ill children who treated by CRRT and CRRT mode is decide as CVVHDF. Receives: Other: Treatment | |
| 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 Receives: Other: Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival rate
The survival rate of children in 28 days after their hospital discharged.
Measured: 28 days
Secondary outcomes (2)
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 .
Measured: 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
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start30 Oct 2018 (estimated)
- Primary completion30 Oct 2020 (estimated)
- Study completion30 Oct 2021 (estimated)
Why it stopped: Interruption of financial support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Guoping Lu
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Children's Hospital, Shanghai Children's Medical Center, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Responsible party
- Sponsor-investigator, Guoping Lu, Children's Hospital of Fudan University
- Investigators
- Guoping LU, doctor, Principal investigator, Children's Hospital of Fundan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03654287
- Sponsor's protocol ID
- fdpicu-02
- Acronym
- CELS
- Status last verified
- May 2019
- First submitted
- 29 Aug 2018
- Last updated
- 8 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring and Establishment of Multiple Organ Support Therapy（CELS）in Critically Ill Children
- ClinicalTrials.gov ID
- NCT03654287
- Acronym / sponsor ID
- CELS / fdpicu-02
- Conditions
- Sepsis, Critical Illness, MODS
- Keywords
- sepsis, CRRT, ECMO, CELS
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Interruption of financial support
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Guoping LuUniversity, hospital or other
- Collaborators
- Shanghai Children's Hospital, Shanghai Children's Medical Center, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Study start
- 30 Oct 2018 (estimated)
- Primary completion
- 30 Oct 2020 (estimated)
- Study completion
- 30 Oct 2021 (estimated)
- First posted
- 31 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 28 Days
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Treatment with CPFA | – | Other: TreatmentThe critically ill children who treated by CRRT and CRRT mode is decide as CPFA. |
| Treatment with TPE+CVVHDF | – | Other: TreatmentThe critically ill children who treated by CRRT and CRRT mode is decide as TPE+CVVHDF. |
| Treatment with CVVHDF | – | Other: TreatmentThe critically ill children who treated by CRRT and CRRT mode is decide as CVVHDF. |
| Treatment without CRRT/ECMO | – | –The critically ill children who are not treated by CRRT or ECMO. |
| Treatment with ECMO | – | Other: TreatmentThe critically ill children who are treated by ECMO whether treated by CRRT |
Who may qualify
- Ages
- 29 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with severe sepsis and refractory shock admitted to the PICU of four study centers.
Key inclusion criteria (2 listed)
- Children with severe sepsis and refractory shock admitted to the PICU of four study centers.
- The informed consent of the guardians
Key exclusion criteria (1 listed)
- active hemorrhage difficult catheter placing Irreversible brain damage patients enrolled in other clinic trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TreatmentThe CELS way to intervene severe sepsis and refractory shock | Other | Treatment with CPFA, Treatment with CVVHDF, Treatment with ECMO, Treatment with TPE+CVVHDF |
Primary outcome
survival rate
Time frame: 28 days
The survival rate of children in 28 days after their hospital discharged.
2 secondary outcomes
Pediatric Risk of Mortality score （PRISM III）
Time frame: the first 24 hours after admitted to PICU
ECMO weaning rate
Time frame: 48 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guoping LU, doctor principal investigator
Children's Hospital of Fundan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Critical Illness, run by Guoping Lu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival rate (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2019.