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Tissue Oxygenation During Treatment of Infant Congenital Heart Defects

Tissue Oxygenation During Treatment of Infant Congenital Heart Defects

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03941015
Enrollment
245
Registered
2019-05-07
Start date
2018-12-01
Completion date
2021-01-30
Last updated
2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury, Hypoxia-Ischemia, Brain, Mesenteric Ischemia

Keywords

Near infrared spectroscopy, Acute Kidney Injury, congenital heart disease

Brief 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.

Interventions

None listed

Sponsors

Beijing Anzhen Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Months to 12 Months
Healthy volunteers
No

Inclusion criteria

1. Age ≤ 1 year 2. Diagnosis of ventricular septal defect 3. Undergoing cardiac surgery with cardiopulmonary bypass

Exclusion criteria

1. refusal to participate; 2. emergent or urgent surgery; 3. weight \>10 kg; 4. preoperative renal dysfunction; 5. multiple organ dysfunction; 6. chromosomal abnormalities; 7. skin condition precluding the application of near-infrared spectroscopy probe.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Acute Kidney Injury3 daysAKI 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.

Secondary

MeasureTime frameDescription
Length of Hospital Stayup to 60 daysLength of hospital stay after surgery
Duration of Stay in the Intensive Care Unitup to 60 daysDuration of Stay in the intensive care unit after surgery
Duration of Mechanical Ventilationup to 1440 hoursHours of mechanical ventilation after surgery
Number of Participants Reaching Kidney Disease: Improving Global Outcomes (KDIGO) Stage 23 daysKDIGO 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.
Number of Participants Reaching Kidney Disease: Improving Global Outcomes (KDIGO) Stage 33 daysKDIGO 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.
Number of Participants Reaching Kidney Disease: Improving Global Outcomes (KDIGO) Stage 13 daysKDIGO 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.

Countries

China

Participant flow

Recruitment details

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.

Pre-assignment details

Three patients were dropped due to missing data. The final analysis included 242 patients.

Participants by arm

ArmCount
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.
38
Patients Without Renal Desaturation
Patients who did't undergo a decrease of SrtO2 measurement from the baseline value for more than 20% lasting for more than 60 s.
204
Total242

Baseline characteristics

CharacteristicPatients Without Renal DesaturationPatients With Renal DesaturationTotal
Age, Continuous5.0 month4.8 month5.0 month
Body surface area(BSA)0.32 m^2
STANDARD_DEVIATION 0.05
0.31 m^2
STANDARD_DEVIATION 0.05
0.31 m^2
STANDARD_DEVIATION 0.05
creatinine18.6 μmol/L19.1 μmol/L18.8 μmol/L
Ejection fraction70.7 Percentage of blood
STANDARD_DEVIATION 5.1
70.2 Percentage of blood
STANDARD_DEVIATION 5.9
70.6 Percentage of blood
STANDARD_DEVIATION 5.2
Height63 cm
STANDARD_DEVIATION 6
64 cm
STANDARD_DEVIATION 5
64 cm
STANDARD_DEVIATION 5
hemoglobin11.3 g/L
STANDARD_DEVIATION 0.8
11.5 g/L
STANDARD_DEVIATION 0.7
11.4 g/L
STANDARD_DEVIATION 0.8
Left ventricular end-diastolic diameter29.9 mm
STANDARD_DEVIATION 3.8
30.0 mm
STANDARD_DEVIATION 4.5
29.9 mm
STANDARD_DEVIATION 3.9
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
204 Participants38 Participants242 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Sex: Female, Male
Female
93 Participants13 Participants106 Participants
Sex: Female, Male
Male
111 Participants25 Participants136 Participants
SrtO275 percentage of oxyhemoglobin77 percentage of oxyhemoglobin75 percentage of oxyhemoglobin
urea nitrogen3.0 mmol/L
STANDARD_DEVIATION 1.3
3.3 mmol/L
STANDARD_DEVIATION 1.1
3.1 mmol/L
STANDARD_DEVIATION 1.2
ventricular septal defect size9.0 mm9.0 mm9.0 mm
Weight5.9 kg6.0 kg5.9 kg

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 380 / 204
other
Total, other adverse events
0 / 380 / 204
serious
Total, serious adverse events
0 / 380 / 204

Outcome results

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.

Time frame: 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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Patients With Renal DesaturationNumber of Participants With Acute Kidney Injury18 Participants
Patients Without Renal DesaturationNumber of Participants With Acute Kidney Injury57 Participants
Secondary

Duration of Mechanical Ventilation

Hours of mechanical ventilation after surgery

Time frame: 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.

ArmMeasureValue (MEDIAN)
Patients With Renal DesaturationDuration of Mechanical Ventilation51 hour
Patients Without Renal DesaturationDuration of Mechanical Ventilation29 hour
Secondary

Duration of Stay in the Intensive Care Unit

Duration of Stay in the intensive care unit after surgery

Time frame: 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.

ArmMeasureValue (MEDIAN)
Patients With Renal DesaturationDuration of Stay in the Intensive Care Unit13 day
Patients Without Renal DesaturationDuration of Stay in the Intensive Care Unit12 day
Secondary

Length of Hospital Stay

Length of hospital stay after surgery

Time frame: 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.

ArmMeasureValue (MEDIAN)
Patients With Renal DesaturationLength of Hospital Stay5 day
Patients Without Renal DesaturationLength of Hospital Stay4 day
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.

Time frame: 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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Patients With Renal DesaturationNumber of Participants Reaching Kidney Disease: Improving Global Outcomes (KDIGO) Stage 112 Participants
Patients Without Renal DesaturationNumber of Participants Reaching Kidney Disease: Improving Global Outcomes (KDIGO) Stage 152 Participants
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.

Time frame: 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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Patients With Renal DesaturationNumber of Participants Reaching Kidney Disease: Improving Global Outcomes (KDIGO) Stage 24 Participants
Patients Without Renal DesaturationNumber of Participants Reaching Kidney Disease: Improving Global Outcomes (KDIGO) Stage 24 Participants
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.

Time frame: 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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Patients With Renal DesaturationNumber of Participants Reaching Kidney Disease: Improving Global Outcomes (KDIGO) Stage 32 Participants
Patients Without Renal DesaturationNumber of Participants Reaching Kidney Disease: Improving Global Outcomes (KDIGO) Stage 31 Participants

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026