NIRS for the Diagnosis and Prevention of Acute Renal Failure

NCT04605705 | Unknown DMC

• 1 other identifier: FM389
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Renal Insufficiency, Acute

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  7 days

Secondary Outcomes (4)

• Need for dialysis

  7 days

• Duration of mechanical ventilation

  7 days

• Length of stay in intensive care units (ICU)

  1 month

• Deaths within 30 days postoperative

  30 days

Study Arms (2)

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%.

Combination Product: Optimization of the cardiac output, the temperature, the hemoglobin in order to have the NIRS value by up to 80%.

Interventions

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%.

Group 2

Eligibility Criteria

• Age: 1 Day - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saint-Joseph University: lead

Study Sites (1)

Hotel Dieu de France Hospital

Beirut, 166830, Lebanon

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

A blood test for the dosage of creatinine and urea.

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• AFRIDA GERGESS, M.D.

  Hotel Dieu de France Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AFRIDA H GERGESS, M.D.

CONTACT

009613957831; gergessafrida@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: October 28, 2020
• Study Start: September 23, 2020
• Primary Completion: August 1, 2021
• Study Completion: September 1, 2021
• Last Updated: October 28, 2020

Record last verified: 2020-10

Locations

LE (1)