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NIRS for the Diagnosis and Prevention of Acute Renal Failure

NCT04605705 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2020-10-28

No results posted yet for this study

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

Interventions

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%.

Sponsors & Collaborators

  • Saint-Joseph University

    lead OTHER

Principal Investigators

  • AFRIDA GERGESS, M.D. · Hotel Dieu de France Hospital

Eligibility

Min Age
1 Day
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-23
Primary Completion
2021-08-31
Completion
2021-09-30

Countries

  • Lebanon

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04605705 on ClinicalTrials.gov