Incidence, risk and risk factors for acute kidney injury associated with the use of indomethacin injection in neonatal patent ductus arteriosus: a 15-Year experience

Not Applicable

Completed

• Conditions: acute kidney injury in neonatal patent ductus arteriosus; Indomethacin, acute kidney injury, renal impairment, renal dysfunction, cohort, patent ductus arteriosus, neonates

• Registration Number: TCTR20190607002
• Lead Sponsor: Department of Clinical Pharmacy, Faculty of Pharmaceutical Sciences, Prince of Songkla University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-07
• Study Completion: 2019-08-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 205

Inclusion Criteria

-neonatal patients who were admitted to the NICU between January 2003 and December 2018. Exposed group includes neonatal patients diagnosed with PDA who receives INDO for closure of DA. All diagnoses were recorded according to the International Classification of Diseases 10th revision (ICD-10). (ICD-10 code Q25.0). The non-exposed group includes neonatal patients who were diagnosed with PDA or not and without INDO exposure, matched (1:1) with gestational age and birth weight to the exposed group. The echocardiographic test result, the gold standard method, was used for confirmed diagnosis of PDA among neonatal patients in both exposed and non-exposed groups. However, the echocardiographic test was not performed for confirmation of all PDA closure among neonatal patients. The clinical evidence of ductal closure was used for confirmation of PDA closure. In case the closure of PDA was doubted, the echocardiographic test would be performed for PDA closure confirmation. The criteria for diagnosis of a hemodynamically significant PDA were ductal size >1.5 mm, left atrial to aortic (LA:AO) ratio > 1, and left-to right shunting of blood.46
-neonatal patients with availability of baseline SCr concentrations prior to the study entry

Exclusion Criteria

-all neonates diagnosed prior to the study entry with congenital renal anomalies, including, renal artery stenosis (ICD-10 code Q27.1, Q Q27.2), arteriovenous malformation of renal vessel (ICD-10 code Q27.34), dysplasia/hypoplasia (ICD-10 code Q60.3, Q60.4), cystic renal diseases (ICD-10 code Q61.00, Q61.01, Q61.11-Q61.3), other specified congenital malformations of kidney (ICD-10 code Q63.8) and congenital renal failure (ICD-10 code Q96.0).
-all neonates diagnosed prior to the study entry with congenital heart anomalies, including, congenital malformation of heart (ICD-10 code Q24.9), congenital heart block (ICD-10 code Q24.6), and other specified congenital malformations of heart (ICD-10 code Q24.8).
-all neonates receiving NSAIDs other than INDO will be excluded.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AKI in each group (exposed group and non-exposed group) At baseline and at day1, 2, 3, 4, 5, 6, 7 and 30 or at discharge after receiving indomethacin AKI was defined according to the neonatal AKI definition

Secondary Outcome Measures

Name	Time	Method
risk, risk factors for AKI - To examine the risk for AKI associated with indomethacin, only the incidence of AKI was included.