A Predictive Score System for AKI Following Pediatric Cardiac Surgery

Derivation and Validation of A Predictive Score System for Acute Kidney Injury Following Pediatric Cardiac Surgery

Sponsors

Lead Sponsor: China National Center for Cardiovascular Diseases

Source China National Center for Cardiovascular Diseases
Brief Summary

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

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.

Overall Status Recruiting
Start Date 2022-04-01
Completion Date 2023-06-30
Primary Completion Date 2023-05-30
Study Type Observational
Primary Outcome
Measure Time Frame
The Prevalence of Acute Kidney Injury Up to postoperative 7 days
Secondary Outcome
Measure Time Frame
The incidence of dialysis Up to postoperative 7 days
The hours of mechanical ventilation Up to postoperative 7 days
The incidence of reinbutation Up to hospital discharge, an average of 7 days
The incidence of tracheotomy Up to hospital discharge, an average of 7 days
The incidence of re-operation Up to hospital discharge, an average of 7 days
The incidence of mechanical cardiac support Up to hospital discharge, an average of 7 days
The incidence of mortality Up to hospital discharge, an average of 7 days
The incidence of pulmonary infection Up to hospital discharge, an average of 7 days
The cost of medical resources Up to hospital discharge, an average of 7 days
Intensive Care Unit Discharge Time Up to ICU discharge, an average of 5 days
Hospital Discharge Time Up to hospital discharge, an average of 7 days
The relative change of left ventricular ejection fraction (LVEF) from baseline to hospital discharge Up to hospital discharge, an average of 7 days
The relative change of left ventricular end-diastolic diameter (LVEDD) from baseline to hospital discharge Up to hospital discharge, an average of 7 days
Enrollment 2000
Condition
Intervention

Intervention Type: Other

Intervention Name: No intervention

Description: No intervention

Eligibility

Sampling Method:

Probability Sample

Criteria:

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

Gender:

All

Minimum Age:

N/A

Maximum Age:

18 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Jianhui Wang, MD Principal Investigator Department of Anesthesiology, Fuwai Hospital, Chinese Academy of Medial Sciences
Overall Contact

Last Name: Jianhui Wang, MD

Phone: +86-010-88398082;

Email: [email protected]

Location
Facility: Status: Contact: Fuwai Hospital Jianhui Wang, M.D.
Location Countries

China

Verification Date

2022-08-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: China National Center for Cardiovascular Diseases

Investigator Full Name: Jianhui Wang

Investigator Title: Department of Anesthesiology

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: AKI

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

Label: No-AKI

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

Patient Data No
Study Design Info

Observational Model: Case-Control

Time Perspective: Prospective

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