NCT03027219

Brief Summary

We aim to evaluate the flow change of arterial anastomosis site during free flap surgery in diabetic patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 23, 2017

Completed
8 days until next milestone

Study Start

First participant enrolled

January 31, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2018

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2018

Completed
Last Updated

November 30, 2018

Status Verified

November 1, 2018

Enrollment Period

1.8 years

First QC Date

January 18, 2017

Last Update Submit

November 29, 2018

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

  • Flow change

    Peak velocity of anastomosis-site of free flap

    before alprostadil administration, 30 mins after alprostadil administration

Interventions

AlprostadilDRUG

Vasodilator for anastomosis-site of free flap

Also known as: Eglandin

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Diabetic patients who are undergoing free flap surgery

You may qualify if:

  • Plan to receive free flap transfer under general anesthesia
  • Age: \>=18 and \<80 years old
  • History of diabetes mellitus
  • Administration of alprostadil during surgery
  • Volunteer, who are provided written informed consent prior to study participation

You may not qualify if:

  • Refuse the participation of study
  • \>= American society of anesthesiologist physical status IV
  • Use of any vasopressor or inotropic for hemodynamic instability before participation of study
  • Inappropriate subjects who are identified by researchers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Alprostadil

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins EProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsFatty Acids, MonounsaturatedAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Young-kug Kim, MD, PhD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 18, 2017

First Posted

January 23, 2017

Study Start

January 31, 2017

Primary Completion

November 2, 2018

Study Completion

November 29, 2018

Last Updated

November 30, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)