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NIRSNCT06705855

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

An observational study of NIRS and Cardiac Surgery Associated - Acute Kidney Injury, run by University of Utah at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
NIRS sensor placement
How many people
100 participants
Where
1 siteUnited States
Study dates
29 May 2025to 30 Aug 2026
How long will I take part?
30 Days
Phase
Observational
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Natalie Silverton, MD contact

801-581-6393

natalie.silverton@hsc.utah.edu

Natalie Bennion, MPH contact

801-585-7697

Natalie.Bennion@utah.edu

United States1 site, 1 recruiting
  • University of Utah

    Salt Lake City, Utah, 84132

    Natalie Silverton, MD, 801-581-6393, natalie.silverton@hsc.utah.edu

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

Acute kidney injury (AKI) is a common complication of cardiac surgery occurring in up to 40% of patients.1, 2 This is more than 10 times the rate of other serious post-surgical complications in cardiac surgery such as stroke or deep sternal infection and is even greater than the incidence of prolonged ventilation.3, 4 Severe AKI requiring new onset dialysis after cardiac surgery occurs in 1-6% of cardiac surgery patients.3, 5 AKI increases length of hospital stay from 5 to 11 days and increases hospital costs from $18,463 to $37,674 per patient.6 The severity of AKI is strongly associated with in-hospital mortality with even the mildest forms of AKI having more than double the mortality and the more severe forms having 10-30 times higher mortality rates (depending on the definition of severe AKI and the patient population).6, 7 AKI contributes to 300,000 annual deaths in the U.S. and 2 million deaths globally each year.8, 9 Considering only the most relevant patient populations (major aortic and spinal surgery, relevant cardiovascular procedures, intensive care patients on mechanical ventilation, severe trauma patients), in the US alone more than 3.1 million patients per year are at risk of AKI.10-14 Of those, 30.6%12, 13, 15 will suffer AKI - adding annual hospital costs of $19 billion.6 It is for these reasons that the Society of Thoracic Surgeons lists renal failure as one of the 5 major complications of cardiac surgery.

The pathophysiology of AKI after cardiac surgery is multifactorial but the profound hemodynamic changes that occur in cardiac surgery likely play an important role. The renal medulla has the highest metabolic activity and least oxygen reserve in the kidney and medullary hypoxia is thought to be a major determinant of AKI.16, 17 One major limitation in the effort to reduce the incidence of AKI is the lack of a real-time monitor of renal hypoxia. As there is no current therapy for AKI once the disease has occurred, prevention is the mainstay of treatment and an important step in preventing AKI is its timely recognition. Current diagnostic methods based on serum creatinine, oliguria, or even novel biomarkers, however, take hours to days to become diagnostic. The investigators have no accepted standard for diagnosing kidney hypoxia in real-time before the injury becomes irreversible. Most clinicians base intraoperative hemodynamic goals for the kidney on "educated guesses" of adequate renal perfusion, since the exact cardiac output or mean arterial pressure targets for preventing AKI are unknown. Even the practice of monitoring urine output is uncertain because of its non-specific relationship to kidney function.18-20 Near infrared spectroscopy (NIRS) is a promising technology for monitoring tissue hypoxia because it is noninvasive and has a long history of clinical use as a monitor of cerebral oximetry in both cardiac and vascular surgery. Because NIRS measures a mixture of arterial and venous capillary oxygenation, it is particularly well-suited to monitor the balance between oxygen consumption and delivery. A large body of literature describes the use of NIRS both as a systemic perfusion monitor and a regional monitor of kidney perfusion in neonates and small children.21-26 In adult cardiac surgery patients, two studies using ultrasound guided placement of NIRS sensors over the kidney found that intraoperative regional tissue oxygen desaturations were associated with the subsequent development of AKI.27, 28 A third study found a correlation between NIRS oxygen saturation measurements over the kidney and renal venous oxygen saturation in adult cardiac surgery patients.29 The problem with these studies, however, is that they excluded patients for body mass index (BMI) greater than 30kg/m2 or if the surface of their kidney was greater than 4cm from the skin. According to the Center for Disease Control, the incidence of obesity (BMI greater than 30kg/m2) is over 40% in the United States and obese patients having cardiac surgery are at increased risk for AKI.30, 31 Thus, if NIRS placed over the kidney in adult patients is to be an effective tool in monitoring kidney hypoxia in adults in the United States, then the technology must be effective in all adult patients.

The major limitation to the use of NIRS for renal hypoxia monitoring in adults is the depth of penetration of the signal. Manufacturers guidelines suggest that the maximum depth of penetration of NIRS is 2.5 cm. The actual depth of penetration of NIRS measurements depends on the source-detector separation, the specific algorithm used, and the optical properties of the tissue being measured. When NIRS is modeled experimentally, there is a nonlinear relationship between source-detector separation and depth of penetration such that a source-detector separation of 20 mm resulted in a depth of penetration of 10 mm but a source-detector separation of 40mm resulted in a depth of penetration of 15mm.32 While in very thin adults, the surface of the kidney may be within 2 cm from the skin, the renal medulla (where most AKI is thought to occur) is several centimeters deeper and thus unlikely to be monitored accurately.

The question then arises as to how these adult cardiac surgery studies showed a relationship between NIRS placed over the kidney, AKI outcome, and even renal venous oxygen saturation.27-29 The lab developed a porcine model in which the investigators directly compared kidney medullary oxygen concentration to NIRS measurements placed over the kidney and the thigh during hemorrhagic shock and aortic occlusion.33 The investigators found during extreme hemodynamic changes such as aortic occlusion, there was a moderate correlation between NIRS and invasive kidney tissue oxygen concentration, but this was true irrespective of whether the NIRS sensors were placed over the kidney or over the thigh. The relationship between kidney NIRS and thigh NIRS was stronger than that with kidney oxygen concentration. This was in animals with kidney surface to skin distances of less than 2 cm. Taken together, these data suggest that renal NIRS in adults may be measuring subcutaneous tissue oxygenation but that it is still a global perfusion monitor that may predict poor global perfusion and AKI risk. Indeed, a study in adult cardiac surgery patients showed that NIRS sensors placed over the thigh predicted subsequent AKI with receiver operator characteristic analysis suggesting an optimal cut-off of 67% and an area under the curve of 0.84.34 The purpose of the current study proposal is to directly compare NIRS placed over the kidney to NIRS placed over the arm or the thigh in adult patients having cardiac surgery at risk for AKI. The hypothesis is that limb NIRS and kidney NIRS will both predict AKI and that the ability of NIRS to predict AKI in adult cardiac surgery patients will be independent of BMI and kidney surface to skin distance.

Being tested
NIRS sensor placement
Keywords
Cardiovascular
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.

  • NIRS sensor placementDevice

    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.

Study groups in NCT06705855
Study groupRoleWhat they receive
Adult cardiac surgery patients undergoing cardiopulmonary bypass surgery at risk for AKIWe will enroll a convenience sample of adult cardiac surgery patients undergoing procedures that require cardiopulmonary bypass (CPB) and who are at risk for AKI.
Receives: Device: NIRS sensor placement

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

Secondary outcomes (8)
  1. The development of severe acute kidney injury (AKI)

    Post-operative AKI as defined by the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines. Measured by an increase in serum creatinine greater than 2.0 - 2.9 times baseline (KDIGO stage 2) or an increase in serum creatinine greater than 3.0 times baseline or greater than 4mg/dl or the initiation of renal replacement therapy (KDIGO stage 3)

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

  2. Ventilator times

    Length of time patient is on ventilator

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

  3. ICU and hospital length of stay

    Time patient is in pre-operation (pre-cardiopulmonary bypass(CPB)), operation (CPB), Post-operation (post-CPB), and ICU.

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

  4. In-hospital mortality

    Number of in-hospital, operative and/or post-operative (cardiopulmonary bypass) deaths

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

  5. Intraoperative hemodynamic changes, mean arterial pressure

    Blood pressure (mmHg) readings will be recorded.

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

  6. Intraoperative hemodynamic changes, oxygen delivery

    Oxygen delivery readings during cardiopulmonary bypass will be recorded (Sp02 using pulse oximeter, measured in liters per minute (LPM)).

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

  7. Intraoperative hemodynamic changes, vasopressor administration

    Vasopressor agent (mcg/kg/min) use will be recorded.

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

  8. Intraoperative hemodynamic changes, anemia

    Intraoperative anemia will be measured on both NIRS measurements, expressed as a % (regional SO2 (rS02)).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2024
  2. Study start29 May 2025
  3. Primary completion30 May 2026 (estimated)
  4. Study completion30 Aug 2026 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
Target duration
30 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT06705855
Sponsor's protocol ID
00179157
Status last verified
Jul 2025
First submitted
19 Nov 2024
Last updated
17 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of NIRS and Cardiac Surgery Associated - Acute Kidney Injury, run by University of Utah at 1 site in United States.

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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 17 Aug 2025. 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 United States. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Natalie Silverton, MD (801-581-6393, natalie.silverton@hsc.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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)). 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 17 Aug 2025.

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