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

Department of Clinical Pharmacy, Faculty of Pharmaceutical Sciences, Prince of Songkla University0 sites205 target enrollmentJune 7, 2019

Overview

Phase: 未知
Intervention: Not specified
Conditions: acute kidney injury in neonatal patent ductus arteriosus
Sponsor: Department of Clinical Pharmacy, Faculty of Pharmaceutical Sciences, Prince of Songkla University
Enrollment: 205
Status: Completed
Last Updated: last year

No summary available.

Registry

who.int

Start Date

June 7, 2019

End Date

August 31, 2019

Last Updated

last year

Study Type

Observational

Sex

All

Sponsor

Department of Clinical Pharmacy, Faculty of Pharmaceutical Sciences, Prince of Songkla University

•\-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

•\-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.