Recruiting

NIRS

Sponsor:

University of Utah

Code:

NCT06705855

Conditions

NIRS

Cardiac Surgery Associated - Acute Kidney Injury

Cardiac Surgery Requiring Cardiopulmonary Bypass

AKI - Acute Kidney Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NIRS sensor placement

Study Details

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

Study ID

NCT06705855

Start date

May 29, 2025

Status verified date

Jul, 2025

Completion date

Aug 30, 2026

Anticipated

Primary completion date

May 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Exclusion criteria will include less than age 18 years old, preoperative end-stage kidney disease requiring dialysis, emergency surgery, or patient refusal.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

NIRS sensor placement

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.

Primary outcome measure

  • Development of post-operative acute kidney injury (AKI) in adult cardiac surgery patients [ Time Frame: From post-operative day 0 to post-operative day 7(KDIGO stage I AKI) ]

Central Contacts and Locations

Central contacts

Natalie Silverton, MD

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

Natalie Bennion, MPH

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

Locations

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84132

Contacts

Natalie Silverton, MD

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

More Information

Sponsor

University of Utah

Last update posted

Aug 17, 2025

Last verified

Jul, 2025

Keywords

  • Cardiovascular

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Utah on 2025-08-17.