CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 245 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT03941015
NCT03941015N/ACompleted

Tissue Oxygenation During Treatment of Infant Congenital Heart Defects

Beijing Anzhen Hospital·observational·Posted May 7, 2019·Updated Mar 17, 2021

In Brief

An observational study for Acute Kidney Injury and 2 related conditions. Completed, enrolled 245 participants across 1 site.

Detailed Summary

Background: Acute kidney injury (AKI) is a common and serious postoperative complication in children with congenital heart disease. In this prospective cohort study, we tested the hypothesis that renal desaturation defined as a 20% decline of renal tissue oxygen saturation (SrtO2) from the baseline value is associated with AKI in infants undergoing ventricular septal defect (VSD) repair with cardiopulmonary bypass (CPB). Methods: Infants aged 1 months to 12 months and scheduled to undergo VSD repair with CPB were eligible. SrtO2 was monitored using a tissue near-infrared spectroscopy. Renal desaturation was defined as a decrease of SrtO2 measurement from the baseline value for more than 20% lasting for more than 60 s. The primary outcome was the incidence of AKI on postoperative 1-3 days according to the Kidney Disease: Improving Global Outcomes criteria. The secondary outcomes included different stages of AKI, duration of postoperative mechanical ventilation, duration of intensive care unit (ICU) and hospital stay, renal replacement therapy (RRT), and in-hospital mortality.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedMay 7, 2019
Enrollment StartDec 1, 2018
Primary CompletionAug 31, 2020
Study CompletionJan 30, 2021
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 7.2 years ago