Clinical trial NCT05945706: Evaluation of Renal Resistive Index in Patients with Controlled Hypotension
Official title: Evaluation of Renal Resistance Index by Doppler Ultrasonography in Patients Undergoing Arthroscopic Shoulder Surgery with Controlled Hypotension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Hypotension, Controlled
Renal Failure
Ultrasonography, Doppler
Keywords: acute kidney injury
blood flow velocity
Renal Doppler ultrasound
Renal Resistive Index
Controlled hypotension
Lead sponsor: Ankara Diskapi Training and Research Hospital
Sponsor class: OTHER
First posted: 2023-07-14
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
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

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Renal resistive index
timeFrame: baseline, pre-surgery
measure: Renal resistive index
timeFrame: immediately after the surgery under anesthesia
measure: Renal resistive index
timeFrame: within 30 minutes after surgery
Secondary outcomes:
measure: serum creatinine
timeFrame: preoperative (baseline)
measure: serum creatinine
timeFrame: postoperative day 1
measure: serum creatinine
timeFrame: postoperative day 2
measure: postoperative urine output
timeFrame: every 6 hours for 48 hours
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Dıskapı Training and Research Hospital
state: Altındağ
Study officials:
affiliation: Ankara Diskapi Training and Research Hospital
name: Fatma Ozkan Sipahioglu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.