Inflammatory Gene Polymorphism and Prolonged Mechanical V... | NCT02402634

Studies
Inflammatory Gene Polymorphism and Prolonged Mechanical Ventilation After Liver Transplantation

NCT02402634

Sponsor

Yonsei University

Status

Completed

Last Update Posted

Feb 15, 2019Actual

Enrollment

141Actual

Phase

Not provided

Conditions

Patients With Postoperative Mechanical Ventilation After Liver Transplantation

Interventions

Mechanical ventilatory lung care

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Jan 8, 2018Actual

Completion Date

Jan 8, 2018Actual

First Submitted Date

Mar 25, 2015

First Submission Date that Met QC Criteria

Mar 25, 2015

First Posted Date

Mar 30, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 14, 2019

Last Update Posted Date

Feb 15, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Mechanical ventilatory lung care is essential for postoperative care in liver transplantation recipients, for such patients are under massive fluid challenge and hemodynamic alterations perioperatively. Some of the recipients experience difficulty in weaning off from the mechanical ventilator due to various causes. This study is to investigate the relationship between the inflammatory gene polymorphism, known for acute lung injury, and the duration of mechanical ventilatory care for such liver transplantation recipients.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

141Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mechanical ventilatory lung care		liver transplantation recipients under mechanical ventilatory lung care	Other: Mechanical ventilatory lung care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mechanical ventilatory lung care	Other		Mechanical ventilatory lung care

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
total duration of postoperative ventilator care	Time for successful weaning from ventilator could correlate with the inflammtory gene polymorphism, especially those related to acute lung injury.	an expected average of 2-3 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

20-65 years old
scheduled for liver transplantation

Exclusion Criteria:

Patients under mechanical ventilation prior to surgery
patients with muscular skeletal disorder, probable cause for respiratory depression
patients not able to read, or understand the consent form
ethnicity, other than asian
patients refusal

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

20-65 years old, scheduled for liver transplantation.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine		Seoul		120-752	South Korea