A Predictive Score System for AKI Following Pediatric Cardiac Surgery

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05489263
• Other study ID #: 2021-LC15
• Status: Recruiting
• Start date: April 1, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: August 2022
• Source: China National Center for Cardiovascular Diseases
• Contact: Jianhui Wang, MD
• Phone: +86-010-88398082
• Email: stewenwang[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: June 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Days to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases
• Surgery--Complications

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
China	Fuwai Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The relative change of left ventricular ejection fraction (LVEF) from baseline to postoperative 1 year	(LVEF at 1 year - LVEF at baseline)/LVEF at baseline * 100%	Up to postoperative 1 year
Other	The relative change of left ventricular end-diastolic diameter (LVEDD) from baseline to postoperative 1 year	(LVEDD at 1 year - LVEDD at baseline)/LVEDD at baseline * 100%	Up to postoperative 1 year
Primary	The Prevalence of Acute Kidney Injury	Acute Kidney Injury was defined by Kidney Disease Improving Global Outcomes (KDIGO) Criteria. Accordingly, AKI was classified as stage 1, stage 2 and stage 3.	Up to postoperative 7 days
Secondary	The incidence of dialysis	The therapeutic approach to correct renal failure	Up to postoperative 7 days
Secondary	The hours of mechanical ventilation	Time before first extubation	Up to postoperative 7 days
Secondary	The incidence of reinbutation	Need for postoperative endotracheal intubation given the occurrence of respiratory or non-respiratory complication after extubation.	Up to hospital discharge, an average of 7 days
Secondary	The incidence of tracheotomy	The necessary treatment for postoperative respiratory failure	Up to hospital discharge, an average of 7 days
Secondary	The incidence of re-operation	Re-exploration prescribed by surgeons due to cardiac issues or excessive chest drainage volume.	Up to hospital discharge, an average of 7 days
Secondary	The incidence of mechanical cardiac support	Supported by extracorporeal membrane oxygenation from operative day to discharge or death	Up to hospital discharge, an average of 7 days
Secondary	The incidence of mortality	Specific death reason	Up to hospital discharge, an average of 7 days
Secondary	The incidence of pulmonary infection	Assessed by relevant guidelines of pulmonary infection	Up to hospital discharge, an average of 7 days
Secondary	The cost of medical resources	The RMB patients spend during the whole hospitalization	Up to hospital discharge, an average of 7 days
Secondary	Intensive Care Unit Discharge Time	Time and date when the patient is transferred to ward	Up to ICU discharge, an average of 5 days
Secondary	Hospital Discharge Time	Time and date when the patient is discharged from the hospital	Up to hospital discharge, an average of 7 days
Secondary	The relative change of left ventricular ejection fraction (LVEF) from baseline to hospital discharge	(LVEF at hospital discharge - LVEF at baseline)/LVEF at baseline * 100%	Up to hospital discharge, an average of 7 days
Secondary	The relative change of left ventricular end-diastolic diameter (LVEDD) from baseline to hospital discharge	(LVEDD at hospital discharge - LVEDD at baseline)/LVEDD at baseline * 100%	Up to hospital discharge, an average of 7 days