A Predictive Score System for AKI Following Pediatric Cardiac Surgery

NCT ID: NCT05489263

Last Updated: 2022-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-01

Study Completion Date

2023-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Congenital Heart Disease Surgery--Complications Acute Kidney Injury

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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AKI

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

No intervention

Intervention Type OTHER

No intervention

No-AKI

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

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

0 Days

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role lead

Responsible Party

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Jianhui Wang

Department of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jianhui Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, Fuwai Hospital, Chinese Academy of Medial Sciences

Locations

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Fuwai Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jianhui Wang, MD

Role: CONTACT

+86-010-88398082;

Facility Contacts

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Jianhui Wang, M.D.

Role: primary

References

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Bie D, Li Y, Wang H, Liu Q, Dou D, Jia Y, Yuan S, Li Q, Wang J, Yan F. Relationship between intra-operative urine output and postoperative acute kidney injury in paediatric cardiac surgery: A retrospective observational study. Eur J Anaesthesiol. 2024 Dec 1;41(12):881-888. doi: 10.1097/EJA.0000000000002044. Epub 2024 Aug 16.

Reference Type DERIVED
PMID: 39021216 (View on PubMed)

Other Identifiers

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2021-LC15

Identifier Type: -

Identifier Source: org_study_id

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