Microcirculation in Venoarterial Extracorporeal Membrane Oxygenation Life Support

NCT02393274 | Completed

• 1 other identifier: 201412045RINA
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure; Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• Perfused small vessel density

  Perfused small vessel density measured by incident dark field video microscope

  At enrollment (within 12 hour after placement of extra-corporeal membrane oxygenation life support)

Secondary Outcomes (3)

• Total small vessel density

  At Enrollment

• Endocan level

  At enrollment

• Microvascular flow index

  At enrollment

Study Arms (2)

28-day Survival

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

Device: Extra-corporeal membrane oxygenation life support

28-day Nonsurvival

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

Device: Extra-corporeal membrane oxygenation life support

Interventions

Extra-corporeal membrane oxygenation life support DEVICE

venoarterial extra-corporeal membrane oxygenation life support

28-day Nonsurvival; 28-day Survival

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 30121090 DERIVED

MeSH Terms

Conditions

Heart Failure; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Respiration Disorders; Respiratory Tract Diseases

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: March 15, 2015
• First Posted: March 19, 2015
• Study Start: April 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 23, 2018

Record last verified: 2016-12

Locations

TW (1)