Acute Kidney Injury in Children After Cardiopulmonary Bypass

Cardiopulmonary Bypass Clinical Trial

Official title:

Early Diagnosis of Acute Kidney Injury in Children With Congenital Heart Disease After Cardiopulmonary Bypass

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03144011
• Other study ID #: 20.03 ?194
• Status: Completed
• Start date: February 8, 2017
• Est. completion date: November 1, 2018

Study information

• Verified date: June 2020
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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%.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 1, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 1 Year

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Cardiopulmonary Bypass
• Congenital Heart Disease in Children
• Heart Defects, Congenital
• Heart Diseases

Locations

Country	Name	City	State
Russian Federation	Siberian Biomedical Research Centre	Novosibirsk	Novosibirsk Region

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	acute renal injury on the scale pRIFLE	diagnosis of acute kidney injury after cardiac surgery	48 hours
Secondary	TIMP-2	elevation of TIMP-2 after cardiac surgery	6 hours
Secondary	renal resistant index with doppler ultrasound	with doppler ultrasound	before, 6 hour, 24 hour