A Predictive Score System for AKI Following Pediatric Cardiac Surgery

National Center for Cardiovascular Diseases

Status: Enrolling

Conditions: Acute Kidney Injury; Surgery--Complications; Congenital Heart Disease

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT05489263

2021-LC15

Details and patient eligibility

About

Acute kidney injury (AKI) has been recognized as a typical post- operative complication among the children undergoing surgical repair of a congenital cardiac defect. It is associated with increased morbidity and mortality in the intensive care unit and a higher utilization of hospital resources. However, how to precisely identify those who have greater hazard to encounter postoperative AKI seems ambiguous.

Full description

The development of AKI is common following cardiac surgery whether in adult or pediatric population. Not only severe AKI like dialysis support, but also mild kidney injury has profound influence on increased subsequent morbidities and mortality.

Pediatric patients who undergo cardiac procedures are characterized by lower weight, younger age, complicated cardiac anomaly and poor resistance to surgical insults. Thus, in comparison with adults, their AKI risk is relatively higher.

At present there has been no specific intervention regarding AKI prevention and therapy. Establishing a risk score based on patient characteristics and surgical information to effectively predict postoperative AKI risk is therefore imperative. It can serve as a decision-making tool to facilitate patient management with regard to kidney prognosis.

This program is aimed at developing and internally validating a AKI risk score post cardiac surgery in a Chinese pediatric population.

Enrollment: 2,000 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. < 18 years old
2. Pediatric patients undergoing cardiac surgery in Fuwai Hospital

Exclusion criteria

1. Supported by dialysis for renal failure prior to cardiac procedure
2. Previously received a renal transplant
3. Lack of preoperative or postoperative serum creatinine measurements
4. Guardians' refusal on informed consent sign

Trial design

2,000 participants in 2 patient groups

AKI

Description:

AKI is defined by KDIGO criterion based on peri-operative serum creatinine variation.

Treatment:

Other: No intervention

No-AKI

Description:

No-AKI is defined by KDIGO criterion based on peri-operative serum creatinine variation.

Treatment:

Other: No intervention