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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with renal desaturation | Patients who underwent a decrease of SrtO2 measurement from the baseline value for more than 20% lasting for more than 60 s. | ||
| patients without renal desaturation | Patients who didn't undergo a decrease of SrtO2 measurement from the baseline value for more than 20% lasting for more than 60 s. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Mechanical Ventilation | Hours of mechanical ventilation after surgery | up to 1440 hours |
| Length of Hospital Stay | Length of hospital stay after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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Infants aged 1 month to 12 months and scheduled to undergo ventricular septal defect repair with cardiopulmenary bypass were eligible.
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| Name | Affiliation | Role |
|---|---|---|
| Boqun Cui, MA | Anzhen hospital Beijing China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anzhen hospital, Beijing | Beijing | Beijing Municipality | 100029 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34446224 | Derived | 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. |
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Three patients were dropped due to missing data. The final analysis included 242 patients.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Renal Desaturation Group | Patients who underwent a decrease of SrtO2 measurement from the baseline value for more than 20% lasting for more than 60 s. |
| FG001 | Renal Eusaturation Group | Patients who didn't undergo a decrease of SrtO2 measurement from the baseline value for more than 20% lasting for more than 60 s. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients With Renal Desaturation | Patients who underwent a decrease of SrtO2 measurement from the baseline value for more than 20% lasting for more than 60 s. |
| BG001 | Patients Without Renal Desaturation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | A total of 245 infants undergoing VSD repair with CPB were enrolled in this study. Three patients were dropped due to missing data. | Posted | Count of Participants | Participants | 3 days |
|
collected until hospital discharge
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients With Renal Desaturation | Patients who underwent a decrease of SrtO2 measurement from the baseline value for more than 20% lasting for more than 60 s. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jun Ma | Department of Anesthesiology, Beijing Anzhen Hospital, Capital Medical University | 13370103671 | 18710168703@163.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 1, 2018 | Jan 20, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D020925 | Hypoxia-Ischemia, Brain |
| D065666 | Mesenteric Ischemia |
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| up to 60 days |
| Duration of Stay in the Intensive Care Unit | Duration of Stay in the intensive care unit after surgery | 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. | 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. | 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. | 3 days |
Patients who did't undergo a decrease of SrtO2 measurement from the baseline value for more than 20% lasting for more than 60 s.
| BG002 | Total | Total of all reporting groups |
| month |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Weight | Median | Inter-Quartile Range | kg |
|
| Height | Mean | Standard Deviation | cm |
|
| Body surface area(BSA) | Mean | Standard Deviation | m^2 |
|
| ventricular septal defect size | Median | Inter-Quartile Range | mm |
|
| Ejection fraction | Mean | Standard Deviation | Percentage of blood |
|
| Left ventricular end-diastolic diameter | Mean | Standard Deviation | mm |
|
| creatinine | Median | Inter-Quartile Range | μmol/L |
|
| SrtO2 | SrtO2 was monitored using a tissue near-infrared spectroscopy oximeter. A biophotonic sensor was placed on the left flank at the level of T10-L2 to monitor SrtO2. SrtO2 was measured during surgery. The baseline SrtO2 was defined as the median value of the data recorded over a 5-minute epoch when the infant was induced and mechanically ventilated and had a cardiac index ≥2.5 L/min/m2, but before skin incision. | Median | Inter-Quartile Range | percentage of oxyhemoglobin |
|
| urea nitrogen | Mean | Standard Deviation | mmol/L |
|
| hemoglobin | Mean | Standard Deviation | g/L |
|
| OG001 |
| Patients Without Renal Desaturation |
Patients who didn't undergo a decrease of SrtO2 measurement from the baseline value for more than 20% lasting for more than 60 s. |
|
|
| Secondary | Duration of Mechanical Ventilation | Hours of mechanical ventilation after surgery | A total of 245 infants undergoing VSD repair with CPB were enrolled in this study. Three patients were dropped due to missing data. | Posted | Median | Inter-Quartile Range | hour | up to 1440 hours |
|
|
|
| Secondary | Length of Hospital Stay | Length of hospital stay after surgery | A total of 245 infants undergoing VSD repair with CPB were enrolled in this study. Three patients were dropped due to missing data. | Posted | Median | Inter-Quartile Range | day | up to 60 days |
|
|
|
| Secondary | Duration of Stay in the Intensive Care Unit | Duration of Stay in the intensive care unit after surgery | A total of 245 infants undergoing VSD repair with CPB were enrolled in this study. Three patients were dropped due to missing data. | Posted | Median | Inter-Quartile Range | day | up to 60 days |
|
|
|
| Secondary | 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. | A total of 245 infants undergoing VSD repair with CPB were enrolled in this study. Three patients were dropped due to missing data. | Posted | Count of Participants | Participants | 3 days |
|
|
|
| Secondary | 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. | A total of 245 infants undergoing VSD repair with CPB were enrolled in this study. Three patients were dropped due to missing data. | Posted | Count of Participants | Participants | 3 days |
|
|
|
| Secondary | 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. | A total of 245 infants undergoing VSD repair with CPB were enrolled in this study. Three patients were dropped due to missing data. | Posted | Count of Participants | Participants | 3 days |
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| 0 |
| 38 |
| EG001 | Patients Without Renal Desaturation | Patients who didn't undergo a decrease of SrtO2 measurement from the baseline value for more than 20% lasting for more than 60 s. | 0 | 204 | 0 | 204 | 0 | 204 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D002534 | Hypoxia, Brain |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000860 | Hypoxia |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010532 | Peritoneal Diseases |
| D018376 | Cardiovascular Abnormalities |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |