A Predictive Score System for AKI Following Pediatric Cardiac Surgery

NCT05489263 | Unknown

• 1 other identifier: 2021-LC15
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Pediatric Cardiac Surgery; Acute Kidney Injury; Prediction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• 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

Other Outcomes (2)

• The relative change of left ventricular ejection fraction (LVEF) from baseline to postoperative 1 year

  Up to postoperative 1 year

• The relative change of left ventricular end-diastolic diameter (LVEDD) from baseline to postoperative 1 year

  Up to postoperative 1 year

Study Arms (2)

AKI

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

Other: No intervention

No-AKI

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

Other: No intervention

Interventions

No intervention OTHER

No intervention

AKI; No-AKI

Eligibility Criteria

• Age: 0 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

A cohort of pediatric patients of 18 years old and younger who have cardiac procedures in Fuwai Hospital, Beijing, China will be consecutively enrolled.

You may qualify if:

• \< 18 years old
• Pediatric patients undergoing cardiac surgery in Fuwai Hospital

You may not qualify if:

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

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 39021216 DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Jianhui Wang, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianhui Wang, MD

CONTACT

+86-010-88398082;; stewenwang@sina.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Anesthesiology

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: August 5, 2022
• Study Start: April 1, 2022
• Primary Completion: May 30, 2023
• Study Completion: June 30, 2023
• Last Updated: August 5, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)