N/A
N=245
Tissue Oxygenation During Treatment of Infant Congenital Heart Defects
Acute Kidney Injury · Hypoxia-Ischemia, Brain · Mesenteric Ischemia
Bottom Line
View on ClinicalTrials.gov: NCT03941015 ↗Enrolled (actual)
245
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Number of Participants With Acute Kidney Injury — 18; 57 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Beijing Anzhen Hospital
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Acute Kidney Injury |
18; 57 | — |
| SECONDARY Duration of Mechanical Ventilation |
51; 29 | — |
| SECONDARY Length of Hospital Stay |
5; 4 | — |
| SECONDARY Duration of Stay in the Intensive Care Unit |
13; 12 | — |
| SECONDARY Number of Participants Reaching Kidney Disease: Improving Global Outcomes (KDIGO) Stage 1 |
12; 52 | — |
| SECONDARY Number of Participants Reaching Kidney Disease: Improving Global Outcomes (KDIGO) Stage 2 |
4; 4 | — |
| SECONDARY Number of Participants Reaching Kidney Disease: Improving Global Outcomes (KDIGO) Stage 3 |
2; 1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age ≤ 1 year
- Diagnosis of ventricular septal defect
- Undergoing cardiac surgery with cardiopulmonary bypass
Exclusion Criteria
- refusal to participate;
- emergent or urgent surgery;
- weight >10 kg;
- preoperative renal dysfunction;
- multiple organ dysfunction;
- chromosomal abnormalities;
- skin condition precluding the application of near-infrared spectroscopy probe.
Data sourced from ClinicalTrials.gov (NCT03941015). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.