NCT02322567

Brief Summary

The purpose of this study is to examine the relationship between pre-operative LV diastolic function and post-operative complications and kidney function in living-donor kidney transplantation patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
242

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Typical duration for all trials

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

Study Start

First participant enrolled

January 1, 2012

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

December 9, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 23, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

February 25, 2016

Status Verified

February 1, 2016

Enrollment Period

3.7 years

First QC Date

December 9, 2014

Last Update Submit

February 24, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patients with postoperative cardiovascular complications

    acute myocardial infarction, ventricular fibrillation/tachycardia, cardiogenic shock, newly-onset atrial fibrillation, clinical pulmonary edema requiring endotracheal intubation or dialysis

    30 days

Secondary Outcomes (1)

  • Patients with postoperative pulmonary edema

    30 days

Other Outcomes (1)

  • Postoperative graft function (graft failure, acute rejection, graft loss, serum creatinine)

    30 days

Study Arms (2)

LV diastolic dysfunction

Other: medical records

No LV diastolic dysfunction

Other: medical records

Interventions

review of medical records

LV diastolic dysfunctionNo LV diastolic dysfunction

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elective kidney transplantation patients

You may qualify if:

  • Elective kidney transplantation patients

You may not qualify if:

  • No data of preoperative echocardiography

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, South Korea

Location

Related Publications (1)

  • Kim EJ, Chang S, Kim SY, Huh KH, Kang S, Choi YS. Predictive Value of Echocardiographic Abnormalities and the Impact of Diastolic Dysfunction on In-hospital Major Cardiovascular Complications after Living Donor Kidney Transplantation. Int J Med Sci. 2016 Jul 18;13(8):620-8. doi: 10.7150/ijms.15745. eCollection 2016.

MeSH Terms

Interventions

Medical Records

Intervention Hierarchy (Ancestors)

RecordsData CollectionEpidemiologic MethodsInvestigative TechniquesOrganization and AdministrationHealth Services AdministrationHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Yong Seon Choi, MD, PhD

    Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

December 9, 2014

First Posted

December 23, 2014

Study Start

January 1, 2012

Primary Completion

September 1, 2015

Study Completion

October 1, 2015

Last Updated

February 25, 2016

Record last verified: 2016-02

Locations