Kidney TransplantationNCT02322567
Left Ventricular Diastolic Dysfunction in Kidney Recipients
An observational study of Kidney Transplantation, run by Severance Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- medical records
- How many people
- 242 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2012to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Elective kidney transplantation patients
Who may be able to join
- Elective kidney transplantation patients
Who cannot join
- No data of preoperative echocardiography
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul
About this study
Official title: Influence of Left Ventricular Diastolic Dysfunction on Graft Function and Postoperative Complication in Patients Undergoing Elective Kidney Transplantation
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.
- Conditions
- Kidney Transplantation
- Being tested
- medical records
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical recordsOther
review of medical records
| Study group | Role | What they receive |
|---|---|---|
| LV diastolic dysfunction | Not described Receives: Other: medical records | |
| No LV diastolic dysfunction | Not described Receives: Other: medical records |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Secondary outcomes (1)
Patients with postoperative pulmonary edema
pulmonary edema by radiological evidence
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study startJan 2012
- Primary completionSep 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, So Yeon Kim, Severance Hospital
- Investigators
- Yong Seon Choi, MD, PhD, Principal investigator, Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02322567
- Sponsor's protocol ID
- 4-2014-0808
- Status last verified
- Feb 2016
- First submitted
- 9 Dec 2014
- Last updated
- 25 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27499694
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Left Ventricular Diastolic Dysfunction on Graft Function and Postoperative Complication in Patients Undergoing Elective Kidney Transplantation
- ClinicalTrials.gov ID
- NCT02322567
- Acronym / sponsor ID
- 4-2014-0808
- Conditions
- Kidney Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Severance HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 23 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LV diastolic dysfunction | – | Other: medical records |
| No LV diastolic dysfunction | – | Other: medical records |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Elective kidney transplantation patients
Key inclusion criteria (1 listed)
- Elective kidney transplantation patients
Key exclusion criteria (1 listed)
- No data of preoperative echocardiography
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| medical recordsreview of medical records | Other | LV diastolic dysfunction, No LV diastolic dysfunction |
Primary outcome
Patients with postoperative cardiovascular complications
Time frame: 30 days
acute myocardial infarction, ventricular fibrillation/tachycardia, cardiogenic shock, newly-onset atrial fibrillation, clinical pulmonary edema requiring endotracheal intubation or dialysis
1 secondary outcome
Patients with postoperative pulmonary edema
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2016.
- Derived from this study: PubMed 27499694Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yong Seon Choi, MD, PhD principal investigator
Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplantation, run by Severance Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients with postoperative cardiovascular complications (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02322567, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2016.