Congenital Heart Disease in ChildrenNCT03144011
Acute Kidney Injury in Children After Cardiopulmonary Bypass
An observational study of Congenital Heart Disease in Children and Cardiopulmonary Bypass, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial summary
Acute kidney injury (AKI) is a common complication in patients with congenital heart defects after cardiopulmonary bypass. The death rate from AKI in critically ill children remains high and reaches 60%. Read more about this study
- Who is it for?
- Ages 1 month to 1 year
- Conditions the study is for
- Congenital Heart Disease in Children, Cardiopulmonary Bypass
- How many people
- 150 participants
- Where
- 1 siteRussia
- Study dates
- 8 Feb 2017to 1 Nov 2018
- 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 1 month to 1 year
- All sexes
- No healthy volunteers
- Child
Study population: Patients aged 1 month to 1 year with congenital heart disease, operated under conditions of cardiopulmonary bypass
Who may be able to join
- Age from 1 month to 1 year Presence of congenital heart disease Radical correction of the defect in conditions of cardiopulmonary bypass
Who cannot join
- Inconsistency with age criteria Cardiotonic support before surgery Acute renal, acute liver failure before surgery
Trial locations and contacts
1 site in 1 country.
Russia1 site
Siberian Biomedical Research Centre
Novosibirsk, Novosibirsk Oblast, 630055
About this study
Official title: Early Diagnosis of Acute Kidney Injury in Children With Congenital Heart Disease After Cardiopulmonary Bypass
Acute kidney injury (AKI) is a common complication in patients with congenital heart defects after cardiopulmonary bypass. The death rate from AKI in critically ill children remains high and reaches 60%.
The basic criteria for diagnosing and assessing the severity of kidney injury until recently were the level of serum creatinine and the amount of urine released. However, it should be noted that the level of serum creatinine, traditionally used to assess renal function, does not significantly increase until a decrease of more than 50% of the glomerular filtration rate, in addition, its level depends also on some extrarenal causes. Artificial blood circulation and hemodilution leads to the preservation of the level of creatinine at sufficiently low levels up to 1-3 days postoperative period. The level of diuresis as well as the level of creatinine is a nonspecific criterion after cardiac surgery and depends on several factors.
Read more
Currently, in the field of acute renal injury studies, progress has been made in the emergence of new biomarkers such as the tissue inhibitor metalloproteinase-2 (TIMP-2) and insulin-like growth factor binding globulin-7 (IGFBP7), which are early markers of acute renal damage. In a study in adult patients, it was shown that the levels of TIMP-2 and IGFBP7 increased In the first 24-48 before the diagnosis of IR-associated renal damage.
Among pediatric patients with congenital heart defects, such studies are single and only present for the age group 3 and older, which also demonstrated the high specificity and prognostic significance of these biomarkers in the early diagnosis of acute renal damage.
It should also be noted that, in spite of the high specificity of the markers described, it is also necessary to note their considerable cost.
Thus, taking into account the above, it is planned to compare and identify the relationship of these indicators with such parameter as the index of renal vascular resistance, the increase of which in the pre- and postoperative period may serve as a sign of the beginning acute renal injury.
- Keywords
- acute kidney injury, cardiosurgery
- Medical subject headings
- Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
acute renal injury on the scale pRIFLE
diagnosis of acute kidney injury after cardiac surgery
Measured: 48 hours
Secondary outcomes (2)
TIMP-2
elevation of TIMP-2 after cardiac surgery
Measured: 6 hours
renal resistant index with doppler ultrasound
with doppler ultrasound
Measured: before, 6 hour, 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start8 Feb 2017
- Primary completion1 Oct 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart Disease in ChildrenStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03144011
- Sponsor's protocol ID
- 20.03 №194
- Status last verified
- Jun 2020
- First submitted
- 4 May 2017
- Last updated
- 22 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Diagnosis of Acute Kidney Injury in Children With Congenital Heart Disease After Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT03144011
- Acronym / sponsor ID
- 20.03 №194
- Keywords
- acute kidney injury, cardiosurgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- 8 Feb 2017 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 8 May 2017 (actual)
- 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 common complication in patients with congenital heart defects after cardiopulmonary bypass. The death rate from AKI in critically ill children remains high and reaches 60%.
The basic criteria for diagnosing and assessing the severity of kidney injury until recently were the level of serum creatinine and the amount of urine released. However, it should be noted that the level of serum creatinine, traditionally used to assess renal function, does not significantly increase until a decrease of more than 50% of the glomerular filtration rate, in addition, its level depends also on some extrarenal causes. Artificial blood circulation and hemodilution leads to the preservation of the level of creatinine at sufficiently low levels up to 1-3 days postoperative period. The level of diuresis as well as the level of creatinine is a nonspecific criterion after cardiac surgery and depends on several factors.
Currently, in the field of acute renal injury studies, progress has been made in the emergence of new biomarkers such as the tissue inhibitor metalloproteinase-2 (TIMP-2) and insulin-like growth factor binding globulin-7 (IGFBP7), which are early markers of acute renal damage. In a study in adult patients, it was shown that the levels of TIMP-2 and IGFBP7 increased In the first 24-48 before the diagnosis of IR-associated renal damage.
Among pediatric patients with congenital heart defects, such studies are single and only present for the age group 3 and older, which also demonstrated the high specificity and prognostic significance of these biomarkers in the early diagnosis of acute renal damage.
It should also be noted that, in spite of the high specificity of the markers described, it is also necessary to note their considerable cost.
Thus, taking into account the above, it is planned to compare and identify the relationship of these indicators with such parameter as the index of renal vascular resistance, the increase of which in the pre- and postoperative period may serve as a sign of the beginning acute renal injury.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients aged 1 month to 1 year with congenital heart disease, operated under conditions of cardiopulmonary bypass
Key inclusion criteria (1 listed)
- Age from 1 month to 1 year Presence of congenital heart disease Radical correction of the defect in conditions of cardiopulmonary bypass
Key exclusion criteria (1 listed)
- Inconsistency with age criteria Cardiotonic support before surgery Acute renal, acute liver failure before surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
acute renal injury on the scale pRIFLE
Time frame: 48 hours
diagnosis of acute kidney injury after cardiac surgery
2 secondary outcomes
TIMP-2
Time frame: 6 hours
renal resistant index with doppler ultrasound
Time frame: before, 6 hour, 24 hour
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 22 Jun 2020.
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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 Congenital Heart Disease in Children and Cardiopulmonary Bypass, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
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 22 Jun 2020. 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 Russia. 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 renal injury on the scale pRIFLE (time frame: 48 hours). 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 22 Jun 2020.