Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03941015 |
Other study ID # |
2018009 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
December 1, 2018 |
Est. completion date |
January 30, 2021 |
Study information
Verified date |
February 2021 |
Source |
Beijing Anzhen Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
Description:
Using near-infrared spectroscopy (NIRS) to monitor intraoperative and postoperative tissue
oxygen saturation and to investigate the correlation with postoperative complications.
Intraoperative hemodynamic parameters were monitored by Mostcare(PRAM, Vygon Health, Padua,
Italy) including cardiac index, systemic vascular resistance index, stroke volume index, the
maximal slope of systolic upstroke, cardiac cycle efficiency.
SrtO2 was monitored using a tissue near-infrared spectroscopy (FORE-SIGHT ELITE tissue
oximeter, CASMED, Branford, Connecticut, USA; now acquired by Edwards Lifesciences, Irvine,
California, USA). A biophotonic sensor was placed on the left flank at the level of T10-L2 to
monitor SrtO2. The tissue oximeter generated a new SrtO2 data every 2 seconds. All these data
were exported from the monitor as the end of surgery. As this is an observational study, the
SrtO2 data were only used for research purpose, not for clinical decision making. The
function of tissue oximeter was checked by a dedicated research personnel in the operating
room. The infant was dropped from the study if the SrtO2 measurements were not available for
more than 5 min during surgery. The baseline SrtO2 was defined as the median value of the
5-minute measurements which were measured following anesthesia induction and during the
period when the cardiac index ≥2.5 L/min/m2. 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 electronic data streams from the NIRS and other patient monitors will be collected into a
study computer. Data collection will initiate at pre-induction of anesthesia in the operating
room. Only the NIRS values will be blinded from clinical use. Blood samples for determining
biomarkers of ischemic tissue injury will be taken at defined intervals. No other
modifications to clinical practice will occur while conducting the study and the NIRS
monitoring is non-invasive.
The primary outcome was the incidence of AKI within 3 days after surgery according to the
Kidney Disease: Improving Global Outcomes (KDIGO) criteria. Secondary outcomes including
different stages of AKI, duration of postoperative mechanical ventilation, duration of
intensive care unit (ICU) and hospital stay, and in-hospital mortality.