Tissue Oxygenation During Treatment of Infant Congenital Heart Defects
Condition: Acute Kidney Injury; Hypoxia-Ischemia, Brain; Mesenteric Ischemia
MeSH terms: Mesenteric Ischemia; Brain Ischemia; Hypoxia-Ischemia, Brain; Acute Kidney Injury; Heart Defects, Congenital; Ischemia; Hypoxia
Study type: Observational

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.
    

Detailed 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.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Infants aged 1 month to 12 months and scheduled to undergo ventricular septal defect repair
        with cardiopulmenary bypass were eligible.
      
Biospecimen description: 
      -  urine samples

        -  blood samples

        -  stool samples
    
Keywords: Near infrared spectroscopy; Acute Kidney Injury; congenital heart disease