Acute Kidney InjuryNCT02916043
Neutrophil, Lymphocyte and Platelet as a Predictor for AKI and Mortality
An observational study of Acute Kidney Injury, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Cell-count related risk factors for acute kidney injury after cardiovascular surgery have been reported. The authors attempted to investigate whether the perioperative cell counts of neutrophil, lymphocyte, platelet are associated with the postoperative acute kidney injury and long-term mortality after cardiovascular… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Cardiovascular surgery with cardiopulmonary bypass
- Type of treatment
- Surgery or procedure
- How many people
- 1,099 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2016to Nov 2016
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients who underwent cardiovascular surgeries with cardiopulmonary bypass (CPB), including valve replacement and surgery on the thoracic aorta at the Seoul National University Hospital between 2007 and 2015
Who may be able to join
- Adult patients who underwent cardiovascular surgeries with cardiopulmonary bypass (CPB), including valve replacement and surgery on the thoracic aorta at the Seoul National University Hospital between 2007 and 2015
Who cannot join
- Missing preoperative serum creatinine (sCr) values
- Missing preoperative platelet, neutrophil and lymphocyte counts
- Patients who underwent preoperative hemodialysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk Factor of Acute Kidney Injury After Open Heart Surgery With Cardiopulmonary Bypass
Cell-count related risk factors for acute kidney injury after cardiovascular surgery have been reported. The authors attempted to investigate whether the perioperative cell counts of neutrophil, lymphocyte, platelet are associated with the postoperative acute kidney injury and long-term mortality after cardiovascular surgery using cardiopulmonary bypass.
Read the detailed description
Acute kidney injury (AKI) after cardiovascular surgery remains a serious complication associated with increased mortality for up to 10 years. The incidence of AKI after cardiovascular surgery is as high as 55% and the incidence of renal replacement therapy (RRT) to be up to 8 %.
Cell-count related risk factors for acute kidney injury after cardiovascular surgery have been reported. The authors attempted to investigate whether the perioperative cell counts of neutrophil, lymphocyte, platelet are associated with the postoperative acute kidney injury and long-term mortality after cardiovascular surgery using cardiopulmonary bypass.
- Conditions
- Acute Kidney Injury
- Being tested
- Cardiovascular surgery with cardiopulmonary bypass
- Keywords
- acute kidney injury, cardiovascular surgery, mortality
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular surgery with cardiopulmonary bypassProcedure or surgery
Patients who underwent cardiovascular surgery including valve replacement or thoracic aortic surgery with cardiopulmonary bypass
| Study group | Role | What they receive |
|---|---|---|
| Cardiovascular surgery with cardiopulmonary bypass | Cardiovascular surgery with cardiopulmonary bypass Receives: Procedure: Cardiovascular surgery with cardiopulmonary bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute kidney injury
acute kidney injury during postoperative seven days defined by Kidney Disease Improving Global Outcomes (KDIGO) criteria
Measured: postoperative day seven
Secondary outcomes (1)
All-cause mortality
all-cause mortality after cardiovascular surgery after postoperative seven years
Measured: postoperative seven years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study startApr 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,099 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won Ho Kim, MD, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02916043
- Sponsor's protocol ID
- 1604-038-753
- Status last verified
- Sep 2016
- First submitted
- 25 Sep 2016
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factor of Acute Kidney Injury After Open Heart Surgery With Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT02916043
- Acronym / sponsor ID
- 1604-038-753
- Conditions
- Acute Kidney Injury
- Keywords
- acute kidney injury, cardiovascular surgery, mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,099 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 27 Sep 2016 (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.
Cell-count related risk factors for acute kidney injury after cardiovascular surgery have been reported. The authors attempted to investigate whether the perioperative cell counts of neutrophil, lymphocyte, platelet are associated with the postoperative acute kidney injury and long-term mortality after cardiovascular surgery using cardiopulmonary bypass.
Detailed description
Acute kidney injury (AKI) after cardiovascular surgery remains a serious complication associated with increased mortality for up to 10 years. The incidence of AKI after cardiovascular surgery is as high as 55% and the incidence of renal replacement therapy (RRT) to be up to 8 %.
Cell-count related risk factors for acute kidney injury after cardiovascular surgery have been reported. The authors attempted to investigate whether the perioperative cell counts of neutrophil, lymphocyte, platelet are associated with the postoperative acute kidney injury and long-term mortality after cardiovascular surgery using cardiopulmonary bypass.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiovascular surgery with cardiopulmonary bypass | – | Procedure: Cardiovascular surgery with cardiopulmonary bypassCardiovascular surgery with cardiopulmonary bypass |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients who underwent cardiovascular surgeries with cardiopulmonary bypass (CPB), including valve replacement and surgery on the thoracic aorta at the Seoul National University Hospital between 2007 and 2015
Key inclusion criteria (1 listed)
- Adult patients who underwent cardiovascular surgeries with cardiopulmonary bypass (CPB), including valve replacement and surgery on the thoracic aorta at the Seoul National University Hospital between 2007 and 2015
Key exclusion criteria (3 listed)
- Missing preoperative serum creatinine (sCr) values
- Missing preoperative platelet, neutrophil and lymphocyte counts
- Patients who underwent preoperative hemodialysis
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 |
|---|---|---|
| Cardiovascular surgery with cardiopulmonary bypassPatients who underwent cardiovascular surgery including valve replacement or thoracic aortic surgery with cardiopulmonary bypass | Procedure or surgery | Cardiovascular surgery with cardiopulmonary bypass |
Primary outcome
Acute kidney injury
Time frame: postoperative day seven
acute kidney injury during postoperative seven days defined by Kidney Disease Improving Global Outcomes (KDIGO) criteria
1 secondary outcome
All-cause mortality
Time frame: postoperative seven years
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 15 Nov 2016.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Acute Kidney Injury, run by Seoul National University 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 3 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 15 Nov 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?
Acute kidney injury (time frame: postoperative day seven). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Nov 2016.