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.

• Recruitment status: COMPLETED
• Target enrollment: 245 participants
• Primary outcome timeframe: 3 days
• Results posted on: 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=5 Participants	5.0 month n=7 Participants	5.0 month n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	93 Participants n=7 Participants	106 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	111 Participants n=7 Participants	136 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	38 Participants n=5 Participants	204 Participants n=7 Participants	242 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Weight	6.0 kg n=5 Participants	5.9 kg n=7 Participants	5.9 kg n=5 Participants
Height	64 cm STANDARD_DEVIATION 5 • n=5 Participants	63 cm STANDARD_DEVIATION 6 • n=7 Participants	64 cm STANDARD_DEVIATION 5 • n=5 Participants
Body surface area(BSA)	0.31 m^2 STANDARD_DEVIATION 0.05 • n=5 Participants	0.32 m^2 STANDARD_DEVIATION 0.05 • n=7 Participants	0.31 m^2 STANDARD_DEVIATION 0.05 • n=5 Participants
ventricular septal defect size	9.0 mm n=5 Participants	9.0 mm n=7 Participants	9.0 mm n=5 Participants
Ejection fraction	70.2 Percentage of blood STANDARD_DEVIATION 5.9 • n=5 Participants	70.7 Percentage of blood STANDARD_DEVIATION 5.1 • n=7 Participants	70.6 Percentage of blood STANDARD_DEVIATION 5.2 • n=5 Participants
Left ventricular end-diastolic diameter	30.0 mm STANDARD_DEVIATION 4.5 • n=5 Participants	29.9 mm STANDARD_DEVIATION 3.8 • n=7 Participants	29.9 mm STANDARD_DEVIATION 3.9 • n=5 Participants
creatinine	19.1 μmol/L n=5 Participants	18.6 μmol/L n=7 Participants	18.8 μmol/L n=5 Participants
SrtO2	77 percentage of oxyhemoglobin n=5 Participants	75 percentage of oxyhemoglobin n=7 Participants	75 percentage of oxyhemoglobin n=5 Participants
urea nitrogen	3.3 mmol/L STANDARD_DEVIATION 1.1 • n=5 Participants	3.0 mmol/L STANDARD_DEVIATION 1.3 • n=7 Participants	3.1 mmol/L STANDARD_DEVIATION 1.2 • n=5 Participants
hemoglobin	11.5 g/L STANDARD_DEVIATION 0.7 • n=5 Participants	11.3 g/L STANDARD_DEVIATION 0.8 • n=7 Participants	11.4 g/L STANDARD_DEVIATION 0.8 • n=5 Participants

PRIMARY outcome

Timeframe: 3 days

Population: 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 hours

Population: 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 days

Population: 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 days

Population: 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 days

Population: 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 days

Population: 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 days

Population: 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

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Patients Without Renal Desaturation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

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

Phone: 13370103671

Email: 18710168703@163.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place