Evaluation of Renal Resistive Index in Patients With Controlled Hypotension

Sponsor
Ankara Diskapi Training and Research Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05945706
Collaborator
(none)
60
1
6
10

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Case-Crossover
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of Renal Resistance Index by Doppler Ultrasonography in Patients Undergoing Arthroscopic Shoulder Surgery With Controlled Hypotension
    Actual Study Start Date :
    Jul 1, 2023
    Anticipated Primary Completion Date :
    Oct 1, 2023
    Anticipated Study Completion Date :
    Dec 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Renal resistive index [baseline, pre-surgery]

      Renal resistive index measurement by Doppler ultrasonography before anesthesia induction

    2. Renal resistive index [immediately after the surgery under anesthesia]

      Renal resistive index measurement by Doppler ultrasonography at the end of surgery under anesthesia

    3. Renal resistive index [within 30 minutes after surgery]

      Renal resistive index measurement by Doppler ultrasonography in the postanesthetic care unit

    Secondary Outcome Measures

    1. serum creatinine [preoperative (baseline)]

      blood serum creatinine level at admission to the hospital

    2. serum creatinine [postoperative day 1]

      blood serum creatinine level on postoperative day one

    3. serum creatinine [postoperative day 2]

      blood serum creatinine level on postoperative day two

    4. postoperative urine output [every 6 hours for 48 hours]

      postoperative urine output measurement

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dıskapı Training and Research Hospital Ankara Altındağ Turkey 06110

    Sponsors and Collaborators

    • Ankara Diskapi Training and Research Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Fatma Özkan Sipahioğlu, MD, Specialist, Principal Investigator, Ankara Diskapi Training and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT05945706
    Other Study ID Numbers:
    • Renal Rezistif Index
    First Posted:
    Jul 14, 2023
    Last Update Posted:
    Jul 14, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Fatma Özkan Sipahioğlu, MD, Specialist, Principal Investigator, Ankara Diskapi Training and Research Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 14, 2023