Urine Biomarkers to Predict Acute Kidney Injury After Pediatric Cardiac Surgery

NCT05637424 | Completed

• 1 other identifier: B670201213147
• Study Type: observational
• Target: 101
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this prospective cohort study is to evaluate, in pediatric patients after cardiac surgery, the predicting capability of biomarkers for acute kidney injury. The main questions it aims to answer:

• The predicting capability of acute kidney injury (AKI) biomarkers for the primary endpoint: the occurrence of AKI stage ≥ 1 within 48-h after intensive care unit (ICU) admission.
• The predicting capability of AKI biomarkers for the secondary endpoint: the occurrence of AKI stage ≥ 2 within 12-h after ICU admission.
• Investigated biomarkers include urine chitinase 3-like protein 1 (uCHI3L1), urine neutrophil gelatinase-associated lipocalin (uNGAL), tissue inhibitor of metalloproteinases-2 (TIMP-2), insulin-like growth factor-binding protein 7(IGFBP7), NephroCheck® and Δ serum creatinine \[postop-preop\]. Differences in concentration between patients with and without AKI development were investigated, as well as AKI diagnostic performance of (combined) biomarkers. During and after cardiac surgery several blood and urine samples will be taken of participants to investigated AKI occurrence and to measure biomarker concentrations.

Conditions

Acute Kidney Injury; Congenital Cardiac Disorders

Keywords

acute kidney injury; pediatric; cardiac surgery; biomarkers

Outcome Measures

Primary Outcomes (1)

• AKI stage ≥ 1

  occurrence of AKI stage ≥ 1 within 48 hours after ICU admission after pediatric cardiac surgery

  48 hours after ICU admission

Secondary Outcomes (1)

• AKI stage ≥ 2

  12 hours after ICU admission

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients (age \<18 years with body weight ≥ 2 kg) who underwent elective cardiac suregry, prospective enrolled preoperatively at Ghent University hospital. Exclusion criteria were AKI stage ≥1 on admission, chronic kidney disease (CKD) stage 5, kidney transplantation, surgery during weekend

You may qualify if:

• pediatric patients (age \<18 years with body weight ≥ 2 kg)
• patient underwent elective cardiac surgery

You may not qualify if:

• AKI stage ≥1 on admission
• chronic kidney disease (CKD) stage 5
• kidney transplantation
• cardiac surgery during weekend

Sponsors & Collaborators

• University Ghent: lead

Related Publications (1)

• Section 2: AKI Definition. Kidney Int Suppl (2011). 2012 Mar;2(1):19-36. doi: 10.1038/kisup.2011.32. No abstract available.

  PMID: 25018918 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine and blood samples were taken. Volume and number of blood samples collected were according to the guidance of the European Commission on blood volume limits for sampling.

MeSH Terms

Conditions

Acute Kidney Injury; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

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

Study Officials

• Eric Hoste, M.D.; Ph.D.

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: December 5, 2022
• Study Start: May 1, 2012
• Primary Completion: May 31, 2014
• Study Completion: April 23, 2018
• Last Updated: December 5, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share