Renal Insufficiency, AcuteNCT04605705
NIRS for the Diagnosis and Prevention of Acute Renal Failure
An observational study of Renal Insufficiency, Acute, run by Saint-Joseph University at 1 site in Lebanon.
Trial summary
This prospective study will take place at Hotel Dieu de France hospital in Lebanon. One hundred children undergoing cardiac surgery for congenital heart disease between May 2020 and May 2021 will be included. After obtaining the informed consent of the parents, demographic and surgical information will be collected. Read more about this study
- Who is it for?
- Ages 1 day to 16 years
- Conditions the study is for
- Renal Insufficiency, Acute
- What is being tested?
- Optimization of the cardiac output, the temperature, the hemoglobin in order to have the NIRS value by up to 80%.
- How many people
- 100 participants
- Where
- 1 siteLebanon
- Study dates
- 23 Sep 2020to Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: All patients aged 16 years and under, with normal renal function who are undergoing cardiac surgery with cardiopulmonary bypass from september 2020 until septembre 2021.
Who may be able to join
- Pediatric patients aged 16 years and under, undergoing cardiac surgery with cardiopulmonary bypass at the hotel Dieu de France Hospital, from September 2020 until September 2021.
- 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
Who cannot join
- The refusal of the patient's parents
- 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
Trial locations and contacts
1 site in 1 country.
Lebanon1 site, 1 recruiting
- Recruiting
Hotel Dieu de France Hospital
Beirut, 166830
AFRIDA H GERGESS, M.D., 009613957831, gergessafrida@gmail.com
khalil Jabbour, M.D.
About this study
Official title: NIRS: a Tool for the Diagnosis and Prevention of Acute Renal Failure in Pediatric Cardiac Surgery
This prospective study will take place at Hotel Dieu de France hospital in Lebanon. One hundred children undergoing cardiac surgery for congenital heart disease between May 2020 and May 2021 will be included. After obtaining the informed consent of the parents, demographic and surgical information will be collected. Serum creatinine, lactic acid, urinary neutrophil gelatinase-associated lipocalin marker (NGAL), and oxygen (O2) saturation will be measured before the operation.
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.
Read the detailed description
This prospective study will take place at Hotel Dieu de France hospital in Lebanon. One hundred children aged 16 and under, undergoing cardiac surgery with cardiopulmonary bypass (CPB) for congenital heart diseases will be included between May 2020 and May 2021. The surgeries to be included will be the tetralogy of Fallot, transposition of the great arteries, ventricular septal defect, atrial septal defect and the atrioventricular canal defect. Any premature under 35 weeks of gestation, the presence of a genetic disease, an abnormal renal ultrasound, a preoperative renal failure with creatinine abnormal for age, or repeated urinary tract infections will be excluded from the study. After obtaining the informed consent of the parents, demographic information (age, weight, height, sex) will be collected..
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
- Renal Insufficiency, Acute
- Being tested
- Optimization of the cardiac output, the temperature, the hemoglobin in order to have the NIRS value by up to 80%.
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimization of the cardiac output, the temperature, the hemoglobin in order to have the NIRS value by up to 80%.Combination product
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%.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | NIRS values will be recorded during the surgery and until 24 hours postoperatively. No intervention will be done. | |
| 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%. Receives: Combination Product: Optimization of the cardiac output, the temperature, the hemoglobin in order to have the NIRS value by up to 80%. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of low renal NIRS values on renal function in children undergoing cardiac surgery.
Monitoring renal NIRS values during the surgery and until 24 hours in the ICU. All values are recorded. A dosage of creatinine is made upon arrival to the ICU , 24 hours later and one week later. A correlation between NIRS values and creatinine changes will be noticed.
Measured: 7 days
Improving NIRS values prevent acute kidney injury in children undergoing cardiac surgery.
Optimizing renal NIRS values in children undergoing cardiac surgery. Each drop in NIRS values below 10% of its baseline is treated with transfusion and increasing the flow of CPB. Postoperatively, creatinine dosage is made upon arrival to the ICU, At day 1 and 7.
Measured: 7 days
Secondary outcomes (4)
Need for dialysis
Need for dialysis during the 1st week after the surgery
Measured: 7 days
Duration of mechanical ventilation
Length of intubation and mechanical ventilation within the 1st postoperative week
Measured: 7 days
Length of stay in intensive care units (ICU)
The length of stay in ICU within the 1st month after the surgery
Measured: 1 month
Deaths within 30 days postoperative
Deaths within 30 days in children after cardiac surgery
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start23 Sep 2020
- Primary completionAug 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Insufficiency, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint-Joseph University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- AFRIDA GERGESS, M.D., Principal investigator, Hotel Dieu de France Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04605705
- Sponsor's protocol ID
- FM389
- Status last verified
- Oct 2020
- First submitted
- 16 Mar 2020
- Last updated
- 28 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NIRS: a Tool for the Diagnosis and Prevention of Acute Renal Failure in Pediatric Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04605705
- Acronym / sponsor ID
- FM389
- Conditions
- Renal Insufficiency, Acute
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Saint-Joseph UniversityUniversity, hospital or other
- Study start
- 23 Sep 2020 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 28 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective study will take place at Hotel Dieu de France hospital in Lebanon. One hundred children undergoing cardiac surgery for congenital heart disease between May 2020 and May 2021 will be included. After obtaining the informed consent of the parents, demographic and surgical information will be collected. Serum creatinine, lactic acid, urinary neutrophil gelatinase-associated lipocalin marker (NGAL), and oxygen (O2) saturation will be measured before the operation.
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
This prospective study will take place at Hotel Dieu de France hospital in Lebanon. One hundred children aged 16 and under, undergoing cardiac surgery with cardiopulmonary bypass (CPB) for congenital heart diseases will be included between May 2020 and May 2021. The surgeries to be included will be the tetralogy of Fallot, transposition of the great arteries, ventricular septal defect, atrial septal defect and the atrioventricular canal defect. Any premature under 35 weeks of gestation, the presence of a genetic disease, an abnormal renal ultrasound, a preoperative renal failure with creatinine abnormal for age, or repeated urinary tract infections will be excluded from the study. After obtaining the informed consent of the parents, demographic information (age, weight, height, sex) will be collected..
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –NIRS values will be recorded during the surgery and until 24 hours postoperatively. No intervention will be done. |
| Group 2 | – | Combination Product: 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%. |
Who may qualify
- Ages
- 1 day to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All patients aged 16 years and under, with normal renal function who are undergoing cardiac surgery with cardiopulmonary bypass from september 2020 until septembre 2021.
Key inclusion criteria (4 listed)
- Pediatric patients aged 16 years and under, undergoing cardiac surgery with cardiopulmonary bypass at the hotel Dieu de France Hospital, from September 2020 until September 2021.
- 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
Key exclusion criteria (7 listed)
- The refusal of the patient's parents
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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%. | Combination product | Group 2 |
Primary outcome
Impact of low renal NIRS values on renal function in children undergoing cardiac surgery.
Time frame: 7 days
Monitoring renal NIRS values during the surgery and until 24 hours in the ICU. All values are recorded. A dosage of creatinine is made upon arrival to the ICU , 24 hours later and one week later. A correlation between NIRS values and creatinine changes will be noticed.
Improving NIRS values prevent acute kidney injury in children undergoing cardiac surgery.
Time frame: 7 days
Optimizing renal NIRS values in children undergoing cardiac surgery. Each drop in NIRS values below 10% of its baseline is treated with transfusion and increasing the flow of CPB. Postoperatively, creatinine dosage is made upon arrival to the ICU, At day 1 and 7.
4 secondary outcomes
Need for dialysis
Time frame: 7 days
Duration of mechanical ventilation
Time frame: 7 days
Length of stay in intensive care units (ICU)
Time frame: 1 month
Deaths within 30 days postoperative
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AFRIDA GERGESS, M.D. principal investigator
Hotel Dieu de France Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Insufficiency, Acute, run by Saint-Joseph University at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact AFRIDA H GERGESS, M.D. (009613957831, gergessafrida@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of low renal NIRS values on renal function in children undergoing cardiac surgery. (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2020.