Patients Undergoing Surgery for Congenital Heart DiseaseNCT02081235
Incidence, Risk Factors, and Risk Model of Acute Kidney Injury in Pediatric Patients Who Undergoing Surgery for Congenital Heart Disease
An observational study of Patients Undergoing Surgery for Congenital Heart Disease, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Acute kidney injury (AKI) is a major complication after cardiac surgery and has been reported to be associated with adverse outcome. Previous studies have reported that the incidence of AKI in patients undergoing surgery for congenital heart disease is as high as 42% and AKI increase the patient mortality, intensive… Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Patients Undergoing Surgery for Congenital Heart Disease
- What is being tested?
- surgery for congenital heart disease
- Type of treatment
- Surgery or procedure
- How many people
- 220 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2014to Feb 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: patients who underwent surgery for congenital heart disease between 2009 and 2013 in Samsung Medical Center
Who may be able to join
- patients who underwent surgery for congenital heart disease between January 2012 and December 2012 in Samsung Medical Center
Who cannot join
- incomplete data for creatinine, estimated glomerular filtration rate, or urine output required to diagnose acute kidney injury
- patients who expired within 24 hours after surgery
Trial locations and contacts
1 site in 1 country.
About this study
Acute kidney injury (AKI) is a major complication after cardiac surgery and has been reported to be associated with adverse outcome. Previous studies have reported that the incidence of AKI in patients undergoing surgery for congenital heart disease is as high as 42% and AKI increase the patient mortality, intensive care unit stay and hospital stay. Previous studies have reported several risk factors for AKI after congenital heart surgery, however, perioperative variables including anesthesia-related factors have not been evaluated fully. Therefore, the investigators attempt to find out independent risk factors regarding perioperative variables.
Read the detailed description
Acute kidney injury (AKI) is a major complication after cardiac surgery and has been reported to be associated with adverse outcome. Previous studies have reported that the incidence of AKI in patients undergoing surgery for congenital heart disease is as high as 42% and AKI increase the patient mortality, intensive care unit stay and hospital stay. Previous studies have reported several risk factors for AKI after congenital heart surgery, however, perioperative variables including anesthesia-related factors have not been evaluated fully. In addition, a neutrophil-lymphocyte ratio (NLR), which have been reported to be a marker for systemic inflammation and associated with prognosis of cardiac and cancer patients might be able to predict development of postoperative AKI. Therefore, the investigators attempt to assess independent risk factors regarding perioperative variables including transfusion-related parameters, preoperative anemia, preoperative hypoalbuminemia, pulmonary hypertension, use of nitric oxide, use of hydroxyethyl starch, perioperative medication, hemodynamic variables and perioperative NLR.
- Being tested
- surgery for congenital heart disease
- Keywords
- congenital heart disease, acute kidney injury, risk factor, anesthesia
- Medical subject headings
- Heart Defects, Congenital, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgery for congenital heart diseaseProcedure or surgery
surgery for congenital heart disease
| Study group | Role | What they receive |
|---|---|---|
| patients who underwent surgery for congenital heart disease | patients who underwent surgery for congenital heart disease during 2012 in Samsung Medical Center Receives: Procedure: surgery for congenital heart disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute kidney injury as defined by KDIGO (Kidney Disease: Improving Global outcome) criteria
Acute kidney injury as defined by KDIGO criteria (Stage 1, 2, 3)
Measured: during seven days after surgery
Secondary outcomes (2)
Acute kidney injury as defined by AKIN (acute kidney injury network) criteria
Acute kidney injury as defined by AKIN (acute kidney injury network) criteria within 48 hours after surgery
Measured: within 48 hours after surgery
acute kidney injury diagnosis defined by RIFLE criteria
acute kidney injury diagnosis defined by RIFLE criteria (for Risk, Injury, Failure during seven days after surgery
Measured: during seven days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2014 (estimated)
- Study startJun 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Undergoing Surgery for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WonHo Kim, Samsung Medical Center
- Investigators
- Won Ho Kim, MD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02081235
- Sponsor's protocol ID
- 2013-12-101
- Status last verified
- Jun 2016
- First submitted
- 5 Mar 2014
- Last updated
- 16 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence, Risk Factors, and Risk Model of Acute Kidney Injury in Pediatric Patients Who Undergoing Surgery for Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT02081235
- Acronym / sponsor ID
- 2013-12-101
- Keywords
- congenital heart disease, acute kidney injury, risk factor, anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 7 Mar 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.
Acute kidney injury (AKI) is a major complication after cardiac surgery and has been reported to be associated with adverse outcome. Previous studies have reported that the incidence of AKI in patients undergoing surgery for congenital heart disease is as high as 42% and AKI increase the patient mortality, intensive care unit stay and hospital stay. Previous studies have reported several risk factors for AKI after congenital heart surgery, however, perioperative variables including anesthesia-related factors have not been evaluated fully. Therefore, the investigators attempt to find out independent risk factors regarding perioperative variables.
Detailed description
Acute kidney injury (AKI) is a major complication after cardiac surgery and has been reported to be associated with adverse outcome. Previous studies have reported that the incidence of AKI in patients undergoing surgery for congenital heart disease is as high as 42% and AKI increase the patient mortality, intensive care unit stay and hospital stay. Previous studies have reported several risk factors for AKI after congenital heart surgery, however, perioperative variables including anesthesia-related factors have not been evaluated fully. In addition, a neutrophil-lymphocyte ratio (NLR), which have been reported to be a marker for systemic inflammation and associated with prognosis of cardiac and cancer patients might be able to predict development of postoperative AKI. Therefore, the investigators attempt to assess independent risk factors regarding perioperative variables including transfusion-related parameters, preoperative anemia, preoperative hypoalbuminemia, pulmonary hypertension, use of nitric oxide, use of hydroxyethyl starch, perioperative medication, hemodynamic variables and perioperative NLR.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients who underwent surgery for congenital heart disease | – | Procedure: surgery for congenital heart diseasepatients who underwent surgery for congenital heart disease during 2012 in Samsung Medical Center |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- patients who underwent surgery for congenital heart disease between 2009 and 2013 in Samsung Medical Center
Key inclusion criteria (1 listed)
- patients who underwent surgery for congenital heart disease between January 2012 and December 2012 in Samsung Medical Center
Key exclusion criteria (2 listed)
- incomplete data for creatinine, estimated glomerular filtration rate, or urine output required to diagnose acute kidney injury
- patients who expired within 24 hours after surgery
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 |
|---|---|---|
| surgery for congenital heart diseasesurgery for congenital heart disease | Procedure or surgery | patients who underwent surgery for congenital heart disease |
Primary outcome
Acute kidney injury as defined by KDIGO (Kidney Disease: Improving Global outcome) criteria
Time frame: during seven days after surgery
Acute kidney injury as defined by KDIGO criteria (Stage 1, 2, 3)
2 secondary outcomes
Acute kidney injury as defined by AKIN (acute kidney injury network) criteria
Time frame: within 48 hours after surgery
acute kidney injury diagnosis defined by RIFLE criteria
Time frame: during seven days after surgery
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 16 Jun 2016.
Related trials for Patients Undergoing Surgery for Congenital Heart Disease
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Neonatal Patients Undergoing Major Non-cardiac Surgery, Congenital Anomaly
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Observational Data Collection for Blood Hemoglobin Algorithm Validation in Pediatrics
Hemoglobin, Cerebral Oxygenation
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.
Won Ho Kim, MD principal investigator
Samsung Medical Center
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 Patients Undergoing Surgery for Congenital Heart Disease, run by Samsung Medical Center 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 2 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 16 Jun 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 as defined by KDIGO (Kidney Disease: Improving Global outcome) criteria (time frame: during seven days after surgery). 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 16 Jun 2016.