Evaluation of Renal Resistive Index in Patients with Controlled Hypotension

March 12, 2025 updated by: Fatma Özkan Sipahioğlu, Ankara Diskapi Training and Research Hospital

Evaluation of Renal Resistance Index by Doppler Ultrasonography in Patients Undergoing Arthroscopic Shoulder Surgery with Controlled Hypotension

In recent studies, it has been reported that the renal resistive index is effective in detecting postoperative acute kidney injury in the early period. This study aims to evaluate the preoperative and postoperative renal resistive index variation with intraoperative controlled hypotension and research the renal resistive index's utility in the early detection of renal dysfunction that may develop after surgery.

Study Overview

Detailed Description

Controlled hypotension could be defined as a reduction of the systolic blood pressure to 80-90 mmHg, a reduction of mean arterial pressure (MAP) to 50-65 mmHg, or a 30% reduction of baseline MAP (1). It is frequently applied in orthopedics, neurosurgery, and ear-nose-throat surgeries to reduce blood loss and provide a good field of view to the surgeon. However, the combination of hypotension with hypovolemia may result in postoperative acute kidney injury (AKI), especially in the elderly and in patients with hypoperfusion-sensitive disease. The situation may worsen with nephrotoxic drugs.

In patients with AKI, the length of hospital stay is prolonged, and the risk of morbidity and mortality increases, so early detection of AKI is significant. Perioperative AKI diagnosis is difficult and often delayed. Although there are various tests (cystatin-c, urea, serum creatinine, creatinine clearance, etc.), there is still no early, accurate, easy-to-use AKI marker in clinical practice.

The most commonly used guidelines for AKI classification are 2004-RIFLE (Risk, Injury, Failure, Loss of kidney function, End stage renal disease), 2007-AKIN (Acute Kidney Injury Network), and 2012-KDIGO (Kidney Disease Improving Global Outcomes). Based on the validity of the RIFLE and AKIN criteria, the KDIGO guideline was developed to diagnose AKI with a straightforward definition for clinical practice.

Doppler ultrasonography is widely used in the evaluation of chronic kidney diseases. Renal resistive index (RRI), one of the Doopler-derived indices, is calculated by imaging the intrarenal (arcuate or interlobar) artery and measuring the highest systolic and lowest end-diastolic blood flow velocity using a colored Doppler. It is generally accepted that the normal value of the RRI is 0.60 ± 0.01 (mean±SD), and there is a general opinion that the upper limit of the RRI is 0.7 (2). The renal resistive index has been used for years to diagnose and follow up on various kidney diseases (evaluation of chronic renal allograft rejection, detection and management of renal artery stenosis, and chronic differential diagnosis) (3). Recent studies have reported that RRI effectively detects postoperative AKI in the early period before the criteria for AKIN are formed (4-5).

This study aims to evaluate the preoperative and postoperative renal resistive index variation with intraoperative controlled hypotension and research the renal resistive index's utility in the early detection of renal dysfunction that may develop after surgery.

Study Type

Observational

Enrollment (Actual)

65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Altındağ
      • Ankara, Altındağ, Turkey, 06110
        • Dıskapı Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All ASA I-II-III patients who are scheduled to undergo elective arthroscopic shoulder surgery older than 18 years old

Description

Inclusion Criteria:

  • >18 years old
  • will undergo elective arthroscopic shoulder surgery
  • ASA (American Society of Anesthesiologist Classification) I-II or III

Exclusion Criteria:

  • Cardiac arrhythmia
  • Asymmetric kidney disease
  • Poor echogenicity (for imaging)
  • Chronic renal dysfunction (GFR<30)
  • Renal artery stenosis
  • Endocarditis
  • Postoperative agitation or confusion
  • Postoperative polypnea >35/min or respiratory failure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Renal resistive index
Time Frame: baseline, pre-surgery
Renal resistive index measurement by Doppler ultrasonography before anesthesia induction
baseline, pre-surgery
Renal resistive index
Time Frame: immediately after the surgery under anesthesia
Renal resistive index measurement by Doppler ultrasonography at the end of surgery under anesthesia
immediately after the surgery under anesthesia
Renal resistive index
Time Frame: within 30 minutes after surgery
Renal resistive index measurement by Doppler ultrasonography in the postanesthetic care unit
within 30 minutes after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum creatinine
Time Frame: preoperative (baseline)
blood serum creatinine level at admission to the hospital
preoperative (baseline)
serum creatinine
Time Frame: postoperative day 1
blood serum creatinine level on postoperative day one
postoperative day 1
serum creatinine
Time Frame: postoperative day 2
blood serum creatinine level on postoperative day two
postoperative day 2
postoperative urine output
Time Frame: every 6 hours for 48 hours
postoperative urine output measurement
every 6 hours for 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Fatma Ozkan Sipahioglu, MD, Ankara Diskapi Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Actual)

October 1, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

July 5, 2023

First Submitted That Met QC Criteria

July 12, 2023

First Posted (Actual)

July 14, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 12, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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