- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05945706
Evaluation of Renal Resistive Index in Patients with Controlled Hypotension
Evaluation of Renal Resistance Index by Doppler Ultrasonography in Patients Undergoing Arthroscopic Shoulder Surgery with Controlled Hypotension
Study Overview
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Altındağ
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Ankara, Altındağ, Turkey, 06110
- Dıskapı Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
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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
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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
Investigators
- Principal Investigator: Fatma Ozkan Sipahioglu, MD, Ankara Diskapi Training and Research Hospital
Publications and helpful links
General Publications
- Bossard G, Bourgoin P, Corbeau JJ, Huntzinger J, Beydon L. Early detection of postoperative acute kidney injury by Doppler renal resistive index in cardiac surgery with cardiopulmonary bypass. Br J Anaesth. 2011 Dec;107(6):891-8. doi: 10.1093/bja/aer289. Epub 2011 Sep 22.
- Tublin ME, Bude RO, Platt JF. Review. The resistive index in renal Doppler sonography: where do we stand? AJR Am J Roentgenol. 2003 Apr;180(4):885-92. doi: 10.2214/ajr.180.4.1800885. No abstract available.
- Marty P, Ferre F, Labaste F, Jacques L, Luzi A, Conil JM, Silva S, Minville V. The Doppler renal resistive index for early detection of acute kidney injury after hip fracture. Anaesth Crit Care Pain Med. 2016 Dec;35(6):377-382. doi: 10.1016/j.accpm.2015.12.013. Epub 2016 Apr 28.
- Xu N, Chen L, Liu L, Rong W. Dexmedetomidine versus remifentanil for controlled hypotension under general anesthesia: A systematic review and meta-analysis. PLoS One. 2023 Jan 17;18(1):e0278846. doi: 10.1371/journal.pone.0278846. eCollection 2023.
- Viazzi F, Leoncini G, Derchi LE, Pontremoli R. Ultrasound Doppler renal resistive index: a useful tool for the management of the hypertensive patient. J Hypertens. 2014 Jan;32(1):149-53. doi: 10.1097/HJH.0b013e328365b29c.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Renal Rezistif Index
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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