NIRS for the Diagnosis and Prevention of Acute Renal Failure
NCT ID: NCT04605705
Last Updated: 2020-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2020-09-23
2021-09-30
Brief Summary
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A pediatric NIRS sensor will be placed on the right side below the costo-vertebral angle overlying the right kidney and continuous regional oxygen saturation (rSO2) will be recorded every 5 to 10 minutes throughout the operation until 24 hours after surgery. The children will be divided into 2 groups; 50 each. Grp 1: No clinical intervention was performed based on NIRS values. Grp 2: several maneuvers are performed such as an increase in cardiac output, temperature, hemoglobin to optimize the value of NIRS \> 80%. All patients will receive standard standard care during the study period and continuous infusion of furosemide (0.5-1 mg / kg / 6 hours) within the first 24-48 hours postoperatively will be administered to all patients. Creatinine and lactic acid will be measured immediately postoperatively and then once a day until D2 and D7.
The urinary NGAL marker will be dosed immediately postoperatively and then at 2h, 6h, 12h and 24h with hourly monitoring of diuresis and NIRS until 24h postoperatively.
Detailed Description
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Serum creatinine, lactic acid, urinary NGAL marker, and O2 saturation will be measured before the operation.
A pediatric NIRS sensor will be placed on the right side below the costo-vertebral angle covering the right kidney and continuous rSO2 will be recorded every 5 to 10 minutes throughout the operation as well as with each change of situation, then every hour in pediatric resuscitation until 24 hours postoperatively. The children will be divided into 2 groups of 50 patients each; Grp 1: No clinical intervention will be performed based on the NIRS and Grp 2: several maneuvers will be performed in case the NIRS values are below 50%, such as an increase in cardiac output, temperature, hemoglobin to optimize the NIRS value by up to 80%.
Surgical information (cardiac pathology, surgical procedure, operating time, duration of CPB, duration of aortic cross-clamping, duration of circulatory arrest, intraoperative complications) will be collected.
All patients will receive standard standard care during the study period. Patients will receive continuous infusion of furosemide (0.5-1 mg / kg / 6 hours) within the first 24-48 hours postoperatively.
Postoperatively, the need for catecholamines, the hemodynamic stability according to the Vasoactive-Inotropic Score (VIS), the delay to extubation, the stay in intensive care, the complications that occurred and the need for recourse to the dialysis will be noted.
Creatinine and lactic acid will be measured immediately postoperatively and then once a day until D2 and D7.
The urinary NGAL marker will be dosed immediately postoperatively and then at 2h, 6h, 12h and 24h with hourly monitoring of diuresis and NIRS until 24h postoperatively.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Group 1
NIRS values will be recorded during the surgery and until 24 hours postoperatively. No intervention will be done.
No interventions assigned to this group
Group 2
Several maneuvers will be performed in case the NIRS values are below 50%, such as an increase in cardiac output, temperature, hemoglobin to optimize the NIRS value by up to 80%.
Optimization of the cardiac output, the temperature, the hemoglobin in order to have the NIRS value by up to 80%.
Several maneuvers will be performed in case the NIRS values are below 50%, such as an increase in cardiac output, temperature, hemoglobin to optimize the NIRS value by up to 80%.
Interventions
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Optimization of the cardiac output, the temperature, the hemoglobin in order to have the NIRS value by up to 80%.
Several maneuvers will be performed in case the NIRS values are below 50%, such as an increase in cardiac output, temperature, hemoglobin to optimize the NIRS value by up to 80%.
Eligibility Criteria
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Inclusion Criteria
* Surgeries to include: Tetralogy of Fallot, Transposition of great Vessels, ventricular septal defect, atrial septal defect and atrioventricular septal defect.
* Normal renal function
* Informed consent written and signed by the child's parents
Exclusion Criteria
* Patients with preoperative AKI
* Identification of renal or urinary anatomical abnormalities
* Premature infants \<35 weeks of gestation
* Children with a known genetic or chromosomal abnormality
* Destination to a uni ventricular repair
* Repeated urinary tract infections before the surgery
1 Day
16 Years
ALL
No
Sponsors
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Saint-Joseph University
OTHER
Responsible Party
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Principal Investigators
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AFRIDA GERGESS, M.D.
Role: PRINCIPAL_INVESTIGATOR
Hotel Dieu de France Hospital
Locations
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Hotel Dieu de France Hospital
Beirut, , Lebanon
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FM389
Identifier Type: -
Identifier Source: org_study_id