NCT05945706

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 5, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 14, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 14, 2025

Status Verified

March 1, 2025

Enrollment Period

3 months

First QC Date

July 5, 2023

Last Update Submit

March 12, 2025

Conditions

Acute Kidney InjuryHypotension, ControlledRenal FailureUltrasonography, Doppler

Keywords

acute kidney injuryblood flow velocityRenal Doppler ultrasoundRenal Resistive IndexControlled hypotension

Outcome Measures

Primary Outcomes (3)

  • Renal resistive index

    Renal resistive index measurement by Doppler ultrasonography before anesthesia induction

    baseline, pre-surgery

  • Renal resistive index

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

    immediately after the surgery under anesthesia

  • Renal resistive index

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

    within 30 minutes after surgery

Secondary Outcomes (4)

  • serum creatinine

    preoperative (baseline)

  • serum creatinine

    postoperative day 1

  • serum creatinine

    postoperative day 2

  • postoperative urine output

    every 6 hours for 48 hours

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dıskapı Training and Research Hospital

Ankara, Altındağ, 06110, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 36649357BACKGROUND

  • 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.

    PMID: 12646425BACKGROUND

  • 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.

    PMID: 27133237BACKGROUND

  • 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.

    PMID: 21940396BACKGROUND

  • 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.

    PMID: 24172238BACKGROUND

MeSH Terms

Conditions

Acute Kidney InjuryHypotensionRenal Insufficiency

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Fatma Ozkan Sipahioglu, MD

    Ankara Diskapi Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Specialist, Principal Investigator

Study Record Dates

First Submitted

July 5, 2023

First Posted

July 14, 2023

Study Start

July 1, 2023

Primary Completion

October 1, 2023

Study Completion

December 31, 2023

Last Updated

March 14, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)