NCT03978728

Brief Summary

Extra-corporeal membrane oxygenation (ECMO) can temporarily help patients gain time to wait for cardiopulmonary recovery or further treatment in patients with cardiopulmonary failure. Whether the blood flow provided by the ECMO can maintain the perfusion of various organs is an important factor affecting survival. Some ECMO patients died after the complication of sepsis. Our previous pilot analysis has recognized several ECMO patients with complicated sepsis has high endotoxin activity level. Endotoxemia can also occur in heart surgery and after cardiopulmonary bypass, trauma, organ transplantation, and out-of-hospital cardiac arrest patients. These trials used endotoxin activity analysis (EAA, EAATM, Spectral Diagnostics Inc., Canada) to analyze endotoxin activity. In addition, studies have indicated that the combination of procalcitonin (PCT) concentration and EAA activity can improve the accuracy of predicting sepsis. The primary aim of this study is to detect endotoxin activity in patients with ECMO support and compare whether the prognosis was associated with different level of EAA activity. The secondary aims are to analyze the risk factors leading to high EAA activity and investigate the diagnostic value of septic shock combining PCT examination. We suggest that the results of this study may help the ECMO medical team identify patients at high risk for septic shock and conduct adequate managements to improve patient survival and quality of life after survival.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 7, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

August 21, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
Last Updated

February 9, 2022

Status Verified

February 1, 2022

Enrollment Period

1.4 years

First QC Date

June 2, 2019

Last Update Submit

February 7, 2022

Conditions

Cardiovascular ShockRespiratory Failure

Outcome Measures

Primary Outcomes (1)

  • Endotoxin activity level

    Endotoxin activity level is measured by endotoxin activity analysis kit

    within 48 hours

Secondary Outcomes (6)

  • Endotoxin activity level

    within 24 hours

  • Endotoxin activity level

    within 72 hours

  • Endotoxin activity level

    within 96 hours

  • Procalcitonin level

    within 48 hours

  • Cystatin C level

    within 48 hours

  • +1 more secondary outcomes

Study Arms (1)

ECMO patients

Patients with ECMO support

Device: Extra-corporeal membrane oxygenation

Interventions

Extra-corporeal membrane oxygenationDEVICE

Cardiovascular shock patients received extra-corporeal membrane oxygenation suppot.

ECMO patients

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Paitents with extra-corporeal membrane oxygenation support

You may qualify if:

  • patients with ECMO support

You may not qualify if:

  • \< 20 years old or \> 90 years old
  • not be able to collect blood sample within 48 hours after placement of ECMO
  • change plan to palliative care and plan to remove ECMO
  • non-native speakers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Shock, CardiogenicRespiratory Insufficiency

Interventions

Ex utero Intrapartum Treatment Procedures

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShockRespiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Fetal TherapiesTherapeuticsCesarean SectionDelivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Yu-Chang Yeh, MD, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2019

First Posted

June 7, 2019

Study Start

August 21, 2019

Primary Completion

January 18, 2021

Study Completion

February 28, 2021

Last Updated

February 9, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)