An observational study in Acute Kidney Injury, Hypoxia-Ischemia, Brain and Mesenteric Ischemia, sponsored by Beijing Anzhen Hospital. Completed at 1 site in China. Open to participants aged 1 Month to 12 Months. Per ClinicalTrials.gov, last updated 2021-03-17.
Sponsored by Beijing Anzhen Hospital · Observational
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.
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.
1,691 studies on the registry are indexed under Acute Kidney Injury; 395 are open to participants now.
This study's enrollment of 245 is above the median of 160 across 814 observational studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →Beijing Anzhen Hospital is the lead sponsor of 192 studies on the registry; 102 are open to participants now.
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Infants aged 1 month to 12 months and scheduled to undergo ventricular septal defect repair with cardiopulmenary bypass were eligible.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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.
Time frame: 3 days
Duration of Mechanical Ventilation
Hours of mechanical ventilation after surgery
Time frame: up to 1440 hours
Length of Hospital Stay
Length of hospital stay after surgery
Time frame: up to 60 days
Duration of Stay in the Intensive Care Unit
Duration of Stay in the intensive care unit after surgery
Time frame: up to 60 days
Number of Participants Reaching Kidney Disease: Improving Global Outcomes (KDIGO) Stage 1
KDIGO stage 1 was defined as serum creatinine increased more than 1.5 times serum creatinine baseline. Serum creatinine was recorded within one week before surgery and on postoperative days 1-3. Serum creatinine measured one week before surgery was defined as serum creatinine baseline. KDIGO stage 1 was considered as mild acute kidney injury.
Time frame: 3 days
Number of Participants Reaching Kidney Disease: Improving Global Outcomes (KDIGO) Stage 2
KDIGO stage 2 was defined as serum creatinine increased more than 2 times serum creatinine baseline and less than 3 times serum creatinine baseline. Serum creatinine was recorded within one week before surgery and on postoperative days 1-3. Serum creatinine measured one week before surgery was defined as serum creatinine baseline. Acute kidney injury in KDIGO stage 2 was more serious than acute kidney injury in stage 1.
Time frame: 3 days
Number of Participants Reaching Kidney Disease: Improving Global Outcomes (KDIGO) Stage 3
KDIGO stage 3 was defined as serum creatinine increased more than 3 times baseline, or dialysis requirement, or estimated GFR less than 35 mL/min/1.73m2. Serum creatinine was recorded within one week before surgery and on postoperative days 1-3. Serum creatinine measured one week before surgery was defined as serum creatinine baseline. Acute kidney injury in KDIGO stage 3 was more serious than acute kidney injury in stage 2.
Time frame: 3 days
From December 2018 to August 2020, a total of 245 infants undergoing VSD repair with CPB in Beijing Anzhen Hospital, capital medical university were enrolled in this study.
| Milestone | Renal Desaturation Group | Renal Eusaturation Group |
|---|---|---|
| Started | 38 | 207 |
| Completed | 38 | 204 |
| Not completed | 0 | 3 |
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.
| Participants | Patients With Renal Desaturation | Patients Without Renal Desaturation |
|---|---|---|
| Number of Participants With Acute Kidney Injury | 18 | 57 |
Hours of mechanical ventilation after surgery
| hour | Patients With Renal Desaturation | Patients Without Renal Desaturation |
|---|---|---|
| Duration of Mechanical Ventilation | 51 (28 to 60) | 29 (27 to 51) |
Length of hospital stay after surgery
| day | Patients With Renal Desaturation | Patients Without Renal Desaturation |
|---|---|---|
| Length of Hospital Stay | 5 (3 to 7) | 4 (2 to 5) |
Duration of Stay in the intensive care unit after surgery
| day | Patients With Renal Desaturation | Patients Without Renal Desaturation |
|---|---|---|
| Duration of Stay in the Intensive Care Unit | 13 (11 to 20) | 12 (10 to 15) |
KDIGO stage 1 was defined as serum creatinine increased more than 1.5 times serum creatinine baseline. Serum creatinine was recorded within one week before surgery and on postoperative days 1-3. Serum creatinine measured one week before surgery was defined as serum creatinine baseline. KDIGO stage 1 was considered as mild acute kidney injury.
| Participants | Patients With Renal Desaturation | Patients Without Renal Desaturation |
|---|---|---|
| Number of Participants Reaching Kidney Disease: Improving Global Outcomes (KDIGO) Stage 1 | 12 | 52 |
KDIGO stage 2 was defined as serum creatinine increased more than 2 times serum creatinine baseline and less than 3 times serum creatinine baseline. Serum creatinine was recorded within one week before surgery and on postoperative days 1-3. Serum creatinine measured one week before surgery was defined as serum creatinine baseline. Acute kidney injury in KDIGO stage 2 was more serious than acute kidney injury in stage 1.
| Participants | Patients With Renal Desaturation | Patients Without Renal Desaturation |
|---|---|---|
| Number of Participants Reaching Kidney Disease: Improving Global Outcomes (KDIGO) Stage 2 | 4 | 4 |
KDIGO stage 3 was defined as serum creatinine increased more than 3 times baseline, or dialysis requirement, or estimated GFR less than 35 mL/min/1.73m2. Serum creatinine was recorded within one week before surgery and on postoperative days 1-3. Serum creatinine measured one week before surgery was defined as serum creatinine baseline. Acute kidney injury in KDIGO stage 3 was more serious than acute kidney injury in stage 2.
| Participants | Patients With Renal Desaturation | Patients Without Renal Desaturation |
|---|---|---|
| Number of Participants Reaching Kidney Disease: Improving Global Outcomes (KDIGO) Stage 3 | 2 | 1 |
Collected over collected until hospital discharge. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patients With Renal Desaturation | 0/38 (0%) | 0/38 (0%) | 0/38 (0%) |
| Patients Without Renal Desaturation | 0/204 (0%) | 0/204 (0%) | 0/204 (0%) |
A biophotonic sensor was placed on the left flank at the level of T10-L2 to monitor SrtO2. SrtO2 was measured during surgery. Infants who underwent at least 20% decrease in SrtO2 from the baseline level for at least 60 consecutive seconds were assigned to the renal desaturation group and other infants were assigned to the normal saturation group.
| Age, Continuous(month) | Patients With Renal Desaturation | Patients Without Renal Desaturation | Total |
|---|---|---|---|
| Median | 4.8 (3.1 to 7.5) | 5.0 (3.9 to 7.5) | 5.0 (3.8 to 6.7) |
| Sex: Female, Male(Participants) | Patients With Renal Desaturation | Patients Without Renal Desaturation | Total |
|---|---|---|---|
| Female | 13 | 93 | 106 |
| Male | 25 | 111 | 136 |
| Race (NIH/OMB)(Participants) | Patients With Renal Desaturation | Patients Without Renal Desaturation | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 38 | 204 | 242 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Weight(kg) | Patients With Renal Desaturation | Patients Without Renal Desaturation | Total |
|---|---|---|---|
| Median | 6.0 (4.8 to 6.9) | 5.9 (5.1 to 6.8) | 5.9 (5.1 to 6.8) |
| Height(cm) | Patients With Renal Desaturation | Patients Without Renal Desaturation | Total |
|---|---|---|---|
| Mean | 64 ± 5 | 63 ± 6 | 64 ± 5 |
| Body surface area(BSA)(m^2) | Patients With Renal Desaturation | Patients Without Renal Desaturation | Total |
|---|---|---|---|
| Mean | 0.31 ± 0.05 | 0.32 ± 0.05 | 0.31 ± 0.05 |
| ventricular septal defect size(mm) | Patients With Renal Desaturation | Patients Without Renal Desaturation | Total |
|---|---|---|---|
| Median | 9.0 (7.4 to 11.0) | 9.0 (7.0 to 11.0) | 9.0 (7.0 to 11.0) |
| Ejection fraction(Percentage of blood) | Patients With Renal Desaturation | Patients Without Renal Desaturation | Total |
|---|---|---|---|
| Mean | 70.2 ± 5.9 | 70.7 ± 5.1 | 70.6 ± 5.2 |
5 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
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