Acute Kidney Injury in Children After Cardiopulmonary Bypass

Sponsor
Meshalkin Research Institute of Pathology of Circulation (Other)
Overall Status
Completed
CT.gov ID
NCT03144011
Collaborator
(none)
150
1
20.7
7.2

Study Details

Study Description

Brief 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%.

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Early Diagnosis of Acute Kidney Injury in Children With Congenital Heart Disease After Cardiopulmonary Bypass
    Actual Study Start Date :
    Feb 8, 2017
    Actual Primary Completion Date :
    Oct 1, 2018
    Actual Study Completion Date :
    Nov 1, 2018

    Outcome Measures

    Primary Outcome Measures

    1. acute renal injury on the scale pRIFLE [48 hours]

      diagnosis of acute kidney injury after cardiac surgery

    Secondary Outcome Measures

    1. TIMP-2 [6 hours]

      elevation of TIMP-2 after cardiac surgery

    2. renal resistant index with doppler ultrasound [before, 6 hour, 24 hour]

      with doppler ultrasound

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Month to 1 Year
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Age from 1 month to 1 year Presence of congenital heart disease Radical correction of the defect in conditions of cardiopulmonary bypass

    Exclusion Criteria:

    Inconsistency with age criteria Cardiotonic support before surgery Acute renal, acute liver failure before surgery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Siberian Biomedical Research Centre Novosibirsk Novosibirsk Region Russian Federation 630055

    Sponsors and Collaborators

    • Meshalkin Research Institute of Pathology of Circulation

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Meshalkin Research Institute of Pathology of Circulation
    ClinicalTrials.gov Identifier:
    NCT03144011
    Other Study ID Numbers:
    • 20.03 №194
    First Posted:
    May 8, 2017
    Last Update Posted:
    Jun 22, 2020
    Last Verified:
    Jun 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Meshalkin Research Institute of Pathology of Circulation
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 22, 2020