Trial Outcomes & Findings for Tissue Oxygenation During Treatment of Infant Congenital Heart Defects (NCT NCT03941015)
NCT ID: NCT03941015
Last Updated: 2021-03-17
Results Overview
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.
COMPLETED
245 participants
3 days
2021-03-17
Participant Flow
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.
Three patients were dropped due to missing data. The final analysis included 242 patients.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
207
|
|
Overall Study
COMPLETED
|
38
|
204
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tissue Oxygenation During Treatment of Infant Congenital Heart Defects
Baseline characteristics by cohort
| Measure |
Patients With Renal Desaturation
n=38 Participants
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
n=204 Participants
Patients who did't undergo a decrease of SrtO2 measurement from the baseline value for more than 20% lasting for more than 60 s.
|
Total
n=242 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
4.8 month
n=99 Participants
|
5.0 month
n=107 Participants
|
5.0 month
n=206 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
93 Participants
n=107 Participants
|
106 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=99 Participants
|
111 Participants
n=107 Participants
|
136 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
38 Participants
n=99 Participants
|
204 Participants
n=107 Participants
|
242 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Weight
|
6.0 kg
n=99 Participants
|
5.9 kg
n=107 Participants
|
5.9 kg
n=206 Participants
|
|
Height
|
64 cm
STANDARD_DEVIATION 5 • n=99 Participants
|
63 cm
STANDARD_DEVIATION 6 • n=107 Participants
|
64 cm
STANDARD_DEVIATION 5 • n=206 Participants
|
|
Body surface area(BSA)
|
0.31 m^2
STANDARD_DEVIATION 0.05 • n=99 Participants
|
0.32 m^2
STANDARD_DEVIATION 0.05 • n=107 Participants
|
0.31 m^2
STANDARD_DEVIATION 0.05 • n=206 Participants
|
|
ventricular septal defect size
|
9.0 mm
n=99 Participants
|
9.0 mm
n=107 Participants
|
9.0 mm
n=206 Participants
|
|
Ejection fraction
|
70.2 Percentage of blood
STANDARD_DEVIATION 5.9 • n=99 Participants
|
70.7 Percentage of blood
STANDARD_DEVIATION 5.1 • n=107 Participants
|
70.6 Percentage of blood
STANDARD_DEVIATION 5.2 • n=206 Participants
|
|
Left ventricular end-diastolic diameter
|
30.0 mm
STANDARD_DEVIATION 4.5 • n=99 Participants
|
29.9 mm
STANDARD_DEVIATION 3.8 • n=107 Participants
|
29.9 mm
STANDARD_DEVIATION 3.9 • n=206 Participants
|
|
creatinine
|
19.1 μmol/L
n=99 Participants
|
18.6 μmol/L
n=107 Participants
|
18.8 μmol/L
n=206 Participants
|
|
SrtO2
|
77 percentage of oxyhemoglobin
n=99 Participants
|
75 percentage of oxyhemoglobin
n=107 Participants
|
75 percentage of oxyhemoglobin
n=206 Participants
|
|
urea nitrogen
|
3.3 mmol/L
STANDARD_DEVIATION 1.1 • n=99 Participants
|
3.0 mmol/L
STANDARD_DEVIATION 1.3 • n=107 Participants
|
3.1 mmol/L
STANDARD_DEVIATION 1.2 • n=206 Participants
|
|
hemoglobin
|
11.5 g/L
STANDARD_DEVIATION 0.7 • n=99 Participants
|
11.3 g/L
STANDARD_DEVIATION 0.8 • n=107 Participants
|
11.4 g/L
STANDARD_DEVIATION 0.8 • n=206 Participants
|
PRIMARY outcome
Timeframe: 3 daysPopulation: A total of 245 infants undergoing VSD repair with CPB were enrolled in this study. Three patients were dropped due to missing data.
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.
Outcome measures
| Measure |
Patients With Renal Desaturation
n=38 Participants
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
n=204 Participants
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
|
18 Participants
|
57 Participants
|
SECONDARY outcome
Timeframe: up to 1440 hoursPopulation: A total of 245 infants undergoing VSD repair with CPB were enrolled in this study. Three patients were dropped due to missing data.
Hours of mechanical ventilation after surgery
Outcome measures
| Measure |
Patients With Renal Desaturation
n=38 Participants
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
n=204 Participants
Patients who didn't undergo a decrease of SrtO2 measurement from the baseline value for more than 20% lasting for more than 60 s.
|
|---|---|---|
|
Duration of Mechanical Ventilation
|
51 hour
Interval 28.0 to 60.0
|
29 hour
Interval 27.0 to 51.0
|
SECONDARY outcome
Timeframe: up to 60 daysPopulation: A total of 245 infants undergoing VSD repair with CPB were enrolled in this study. Three patients were dropped due to missing data.
Length of hospital stay after surgery
Outcome measures
| Measure |
Patients With Renal Desaturation
n=38 Participants
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
n=204 Participants
Patients who didn't undergo a decrease of SrtO2 measurement from the baseline value for more than 20% lasting for more than 60 s.
|
|---|---|---|
|
Length of Hospital Stay
|
5 day
Interval 3.0 to 7.0
|
4 day
Interval 2.0 to 5.0
|
SECONDARY outcome
Timeframe: up to 60 daysPopulation: A total of 245 infants undergoing VSD repair with CPB were enrolled in this study. Three patients were dropped due to missing data.
Duration of Stay in the intensive care unit after surgery
Outcome measures
| Measure |
Patients With Renal Desaturation
n=38 Participants
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
n=204 Participants
Patients who didn't undergo a decrease of SrtO2 measurement from the baseline value for more than 20% lasting for more than 60 s.
|
|---|---|---|
|
Duration of Stay in the Intensive Care Unit
|
13 day
Interval 11.0 to 20.0
|
12 day
Interval 10.0 to 15.0
|
SECONDARY outcome
Timeframe: 3 daysPopulation: A total of 245 infants undergoing VSD repair with CPB were enrolled in this study. Three patients were dropped due to missing data.
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.
Outcome measures
| Measure |
Patients With Renal Desaturation
n=38 Participants
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
n=204 Participants
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 Reaching Kidney Disease: Improving Global Outcomes (KDIGO) Stage 1
|
12 Participants
|
52 Participants
|
SECONDARY outcome
Timeframe: 3 daysPopulation: A total of 245 infants undergoing VSD repair with CPB were enrolled in this study. Three patients were dropped due to missing data.
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.
Outcome measures
| Measure |
Patients With Renal Desaturation
n=38 Participants
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
n=204 Participants
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 Reaching Kidney Disease: Improving Global Outcomes (KDIGO) Stage 2
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 3 daysPopulation: A total of 245 infants undergoing VSD repair with CPB were enrolled in this study. Three patients were dropped due to missing data.
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.
Outcome measures
| Measure |
Patients With Renal Desaturation
n=38 Participants
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
n=204 Participants
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 Reaching Kidney Disease: Improving Global Outcomes (KDIGO) Stage 3
|
2 Participants
|
1 Participants
|
Adverse Events
Patients With Renal Desaturation
Patients Without Renal Desaturation
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jun Ma
Department of Anesthesiology, Beijing Anzhen Hospital, Capital Medical University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place