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Microcirculation in Venoarterial Extracorporeal Membrane Oxygenation Life Support

NCT ID: NCT02393274

Last Updated: 2018-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-12-31

Brief Summary

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Extra-corporeal membrane oxygenation (ECMO) life support system can provide both cardiac and respiratory support to patients with heart and respiratory failure. It can save time for these organs to recovery or for these patients to receive further management. However, many patients will die in spite of ECMO support. One of the key factor is whether the blood flow provided by the ECMO can meet the requirement of organ perfusion. The adequacy of macrocirculation may be determined by arterial pressure and minute blood flow of ECMO. However, the adequacy of microcirculation remains as a major unresolved clinical problem. This is a prospective observational clinical trial. The sublingual microcirculation will be examined with the incident dark field video microscope within 6 hours after venoarterial ECMO placement, and then at 24 h, 48 h, 72 h, and 96 h. The severity of multiple organ injury and clinical data will be recorded as well. The major parameters of microcirculation include total small vessel density, perfused small vessel density, and microvascular flow index. The sublingual microcirculation will also be examined before weaning off ECMO, within 6 hours after ECMO removal, and then at 24 h, 48 h, and 72 h. Serum level of endothelial cell specific molecule-1 at specific time points will be examined. The data of 14-day mortality, 28-day mortality, duration of ECMO support, and intensive care unit stay will be recorded. This study aims primarily to investigate the relationship between microcirculation and prognosis of these patients. This study will also investigate the relationship among serum level of endothelial cell specific molecule-1, microcirculation, and prognosis of these patients. Wish the results of this study can be applied in further research to help to improve the quality of ECMO care.

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Detailed Description

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Conditions

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Heart Failure Respiratory Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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28-day Survival

survive for at least 28 days after placement of extra-corporeal membrane oxygenation life support

Extra-corporeal membrane oxygenation life support

Intervention Type DEVICE

venoarterial extra-corporeal membrane oxygenation life support

28-day Nonsurvival

not survive for 28 days after placement of extra-corporeal membrane oxygenation life support

Extra-corporeal membrane oxygenation life support

Intervention Type DEVICE

venoarterial extra-corporeal membrane oxygenation life support

Interventions

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Extra-corporeal membrane oxygenation life support

venoarterial extra-corporeal membrane oxygenation life support

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients who require venoarterial extra-corporeal membrane oxygenation (ECMO) life support

Exclusion Criteria

* who can not take an examination of sublingual microcirculation within 6 hours after placement of venoarterial ECMO support
* Non-native speakers
Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yu-Chang Yeh, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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Yeh YC, Lee CT, Wang CH, Tu YK, Lai CH, Wang YC, Chao A, Huang CH, Cheng YJ, Chen YS; NTUH Center of Microcirculation Medical Research (NCMMR). Investigation of microcirculation in patients with venoarterial extracorporeal membrane oxygenation life support. Crit Care. 2018 Aug 19;22(1):200. doi: 10.1186/s13054-018-2081-2.

Reference Type DERIVED
PMID: 30121090 (View on PubMed)

Other Identifiers

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201412045RINA

Identifier Type: -

Identifier Source: org_study_id

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