A Comparison of Renal vs Limb NIRS for Predicting Cardiac Surgery Associated Acute Kidney Injury

NCT06705855 | Recruiting FDA Device

• 1 other identifier: 00179157
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Acute kidney injury (AKI) is a complication of cardiac surgery that can affect outcome. Near Infrared Spectroscopy (NIRS) is a technology that uses light to determine how well oxygenated tissues are. This technology is routinely used in cardiac surgery to measure the oxygen level in the brain by placing a sensor sticker on the forehead. The purpose of the study is to determine whether NIRS sensor stickers placed on the skin over the kidney can predict AKI better than when sensors are placed on the skin over the participant's limbs. This study is being conducted by investigators from the department of anesthesiology at the University of Utah.

Conditions

NIRS; Cardiac Surgery Associated - Acute Kidney Injury; Cardiac Surgery Requiring Cardiopulmonary Bypass; AKI - Acute Kidney Injury

Keywords

Cardiovascular

Outcome Measures

Primary Outcomes (1)

• Development of post-operative acute kidney injury (AKI) in adult cardiac surgery patients

  The objective of this study is to compare perioperative renal NIRS and limb NIRS and determine whether these measurements can predict acute kidney injury in adult cardiac surgery patients. The primary outcome will be the as defined by the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines. Measured by an increase in serum creatinine greater than 0.3mg/dl (48 hours) or an increase in serum creatinine greater than 1.5 times baseline (7 days).

  From post-operative day 0 to post-operative day 7(KDIGO stage I AKI)

Secondary Outcomes (8)

• The development of severe acute kidney injury (AKI)

  From post-operative day 0 to post-operative day 7(KDIGO stage I AKI)

• Ventilator times

  From post-operative day 0 to end of hospital stay, up to 3 months

• ICU and hospital length of stay

  From post-operative day 0 to end of hospital stay, up to 3 months

• In-hospital mortality

  From post-operative day 0 to end of hospital stay, up to 3 months

• Intraoperative hemodynamic changes, mean arterial pressure

  From start of surgery to end of surgery, up to 24 hours

Study Arms (1)

Adult cardiac surgery patients undergoing cardiopulmonary bypass surgery at risk for AKI

We will enroll a convenience sample of adult cardiac surgery patients undergoing procedures that require cardiopulmonary bypass (CPB) and who are at risk for AKI.

Device: NIRS sensor placement

Interventions

NIRS sensor placement DEVICE

After written informed consent, the patient will be brought to the operating room. Skin tone will be assessed using the Monk scale. Prior to induction of general anesthesia, the right kidney will be located by surface ultrasound, the distance between the renal capsule and the skin will be measured, and a NIRS sensor will be placed on the skin overlaying the kidney. If the patient has had a right nephrectomy, the left kidney will be used. Additional NIRS sensors will then be placed over the patient's ipsilateral biceps and vastus lateralis muscles. The distance from the skin to the muscle tissue will be measured and recorded using ultrasound. NIRS sensors will also be placed on the patient's forehead to measure cerebral oximetry as is current practice at our institution for all cardiac surgeries requiring cardiopulmonary bypass.

Adult cardiac surgery patients undergoing cardiopulmonary bypass surgery at risk for AKI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult cardiac surgery patients undergoing procedures that require cardiopulmonary bypass (CPB) and who are at risk for AKI (determined by the Cleveland Risk Score greater than 6) at the University of Utah medical hospital.

You may qualify if:

• We will enroll a convenience sample of adult cardiac surgery patients undergoing procedures that require cardiopulmonary bypass (CPB) and who are at risk for AKI.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84132, United States

RECRUITING

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

• Natalie Silverton, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natalie Silverton, MD

CONTACT

801-581-6393; natalie.silverton@hsc.utah.edu

Natalie Bennion, MPH

CONTACT

801-585-7697; Natalie.Bennion@utah.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 26, 2024
• Study Start: May 29, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: August 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)