NCT03941015|CompletedResults
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Sponsor study identifier
observational
245
1 country
1
Study Start
December 1, 2018
Actual (reported)Primary Completion
August 31, 2020
Actual (reported)Study Completion
January 30, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 30, 2021
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 19, 2018
Actual (reported)December 1, 2018
Actual (reported)May 7, 2019
Actual (reported)August 31, 2020
Actual (reported)January 30, 2021
Actual (reported)February 9, 2021
Actual (reported)Number of Participants With Acute Kidney Injury
AKI was diagnosed per the Kidney Disease: Improving Global Outcomes (KDIGO) criteria. Acute kidney injury was defined as an increase in serum creatinine to ≥1.5 times baseline within 3 days after surgery. Serum creatinine was recorded within one week before surgery and on postoperative days 1-3. Serum creatinine measured within one week before surgery was defined as serum creatinine baseline.
3 days
Duration of Mechanical Ventilation
up to 1440 hours
Length of Hospital Stay
up to 60 days
Duration of Stay in the Intensive Care Unit
up to 60 days
Number of Participants Reaching Kidney Disease: Improving Global Outcomes (KDIGO) Stage 1
3 days
Number of Participants Reaching Kidney Disease: Improving Global Outcomes (KDIGO) Stage 2
3 days
Patients who underwent a decrease of SrtO2 measurement from the baseline value for more than 20% lasting for more than 60 s.
Patients who didn't undergo a decrease of SrtO2 measurement from the baseline value for more than 20% lasting for more than 60 s.
Infants aged 1 month to 12 months and scheduled to undergo ventricular septal defect repair with cardiopulmenary bypass were eligible.
Anzhen hospital, Beijing
Beijing, Beijing Municipality, 100029, China
Zhang D, Ouyang C, Zhao X, Cui B, Dai F, Meng L, Ma J. Renal tissue desaturation and acute kidney injury in infant cardiac surgery: a prospective propensity score-matched cohort study. Br J Anaesth. 2021 Oct;127(4):620-628. doi: 10.1016/j.bja.2021.06.045. Epub 2021 Aug 24.
* urine samples * blood samples * stool samples
Boqun Cui, MA
Anzhen hospital Beijing China
245 participants (actual enrollment reported by the registry).
First Submitted
November 19, 2018
First Posted
May 7, 2019
Study Start
December 1, 2018
Actual (reported)Predicting Outcomes of Cardiac Surgery-associated Acute Kidney Injury Using Biomarkers At Initiation of RRT
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Primary Completion
August 31, 2020
Actual (reported)Study Completion
January 30, 2021
Actual (reported)Last Updated
March 17, 2021
Results First Posted
February 9, 2021
Record last verified: 2021-02
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