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Acute Kidney InjuryNCT07328620

Is Permissive Hypotension Truly Harmless? Early Biomarker Evidence of Subclinical Kidney Injury in Rhinologic Surgery

An observational study of Acute Kidney Injury and Hypotension, run by Gazi University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to investigate the effects of permissive hypotension, which is routinely used in rhinologic surgeries such as rhinoplasty, septoplasty, and functional endoscopic sinus surgery (FESS), on renal function. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Acute Kidney Injury, Hypotension
How many people
35 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Mar 2025to 30 Jul 2025
How long will I take part?
2 Days
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Adult patients aged 18-65 years undergoing elective rhinologic surgery under controlled hypotension anesthesia at a single tertiary care center will be enrolled. The study population consists of otherwise healthy individuals (ASA I-II) without known kidney disease and without major comorbidities that could independently affect renal function.

Who may be able to join

  • Adults aged 18-65 years
  • Scheduled for elective rhinologic surgery (rhinoplasty, septoplasty, or functional endoscopic sinus surgery)
  • ASA physical status I-II
  • Able to provide written informed consent
  • Undergoing controlled hypotension anesthesia as part of routine clinical management

Who cannot join

  • Known chronic kidney disease (baseline creatinine above normal range or documented CKD)
  • Uncontrolled hypertension or uncontrolled diabetes mellitus
  • Contraindications to controlled hypotensive anesthesia
  • Pregnant or breastfeeding women
  • History of major cardiovascular disease affecting renal perfusion (e.g., severe heart failure)
  • Use of nephrotoxic medications preoperatively that may interfere with renal biomarker interpretation
  • Perioperative complications requiring deviation from routine anesthetic management (e.g., major bleeding or hemodynamic instability)

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Gazi University Faculty of Medicine

    Ankara, Yenimahalle, 06500

Other trials in Turkey (Türkiye)

About this study

Official title: Relationship Between Permissive Hypotension and Acute Kidney Injury in Rhinologic Surgeries: Evaluation With Serum NGAL and Cystatin C Levels

This study aims to investigate the effects of permissive hypotension, which is routinely used in rhinologic surgeries such as rhinoplasty, septoplasty, and functional endoscopic sinus surgery (FESS), on renal function. Although permissive hypotension has been widely practiced to improve surgical field visibility and reduce intraoperative blood loss, its specific definition is not standardized in the literature. In most studies, maintaining mean arterial pressure (MAP) within the range of 50-65 mmHg is considered permissive hypotension. MAP values below 60 mmHg have been associated with increased risk of cardiac and renal complications. However, in otherwise healthy patients, such episodes are frequently tolerated without clinically apparent renal dysfunction.

The kidneys have a strong compensatory reserve capacity, and early tubular injury may not be detected by conventional renal function tests such as serum creatinine. Therefore, the use of more sensitive biomarkers is necessary to detect potential subclinical injury.

Read more

In this prospective observational study, serum NGAL and cystatin C levels will be measured from routine preoperative and postoperative (12-24 hours) blood samples obtained from adult patients undergoing rhinologic procedures. A ≥25% increase in these biomarkers from baseline will be considered indicative of subclinical acute kidney injury.

Additionally, intraoperative hemodynamic data will be monitored, and the duration of MAP <60 mmHg and MAP <65 mmHg will be recorded. At the end of the procedure, surgical field conditions will be evaluated using the Boezaart Surgical Field Score. The relationship between these parameters and biomarker changes will be analyzed.

The goal of this study is to determine whether early, clinically silent renal injury may occur during permissive hypotension and to provide insight into its potential implications for future renal function. All interventions and blood samplings are part of routine care, and no additional procedures will be performed for research purposes.

Read the detailed description

Permissive hypotension is a commonly used anesthetic technique in rhinologic surgeries to optimize surgical conditions by reducing bleeding and improving visualization. Although widely applied, a standardized definition is lacking in the literature. Many studies define permissive hypotension as maintaining mean arterial pressure (MAP) between 50-65 mmHg. MAP values lower than 60 mmHg may compromise tissue perfusion and oxygenation, particularly in the renal medulla, possibly predisposing patients to ischemic stress. Despite this, in patients without significant comorbidities, these controlled reductions typically do not result in clinically evident kidney dysfunction, which supports the continued use of this technique in suitable cases.

However, due to the high renal reserve, subclinical kidney injury may still occur without notable changes in serum creatinine or urine output. The early detection of renal injury may be possible through biomarkers such as neutrophil gelatinase-associated lipocalin (NGAL) and cystatin C, which are more sensitive to structural renal injury. This study is designed to evaluate such potential biomarker changes during permissive hypotension applied for rhinologic surgery.

Study Design and Methods: This is a prospective observational, single-center study including 35 adult patients aged 18-65 years who are scheduled to undergo elective rhinoplasty, septoplasty, or FESS. Patients with a history of chronic kidney disease, uncontrolled hypertension or diabetes mellitus, or contraindications to hypotensive anesthesia will be excluded. Informed consent will be obtained preoperatively. All blood sampling and hemodynamic monitoring will be performed as part of routine clinical care, and no additional intervention will be introduced.

Data Collection and Measurements: Preoperative routine blood samples will be analyzed for renal biomarkers including serum NGAL and cystatin C, in addition to standard biochemistry profiles. Serum NGAL levels will be measured using a validated ELISA method (Elabscience, USA), and serum cystatin C levels will be analyzed using the Siemens Atellica Neph 630 analyzer with a nephelometric method.

Intraoperative hemodynamic variables will be recorded every 5 minutes throughout anesthesia, and total durations of MAP <60 mmHg and MAP <65 mmHg will be calculated. Postoperatively, between 12 and 24 hours, routine blood sampling will again be performed, and NGAL and cystatin C levels will be re-evaluated. At the end of surgery, surgical field visibility will be assessed by the otorhinolaryngology surgical team using the Boezaart Surgical Field Score.

Outcome Measures: The primary outcome of this study is the presence of subclinical renal injury, defined as a ≥25% increase in plasma NGAL and/or cystatin C from preoperative baseline to the postoperative 12-24-hour measurement. Secondary outcomes include the association between biomarker changes and intraoperative hypotension exposure (duration of MAP <60 mmHg and MAP <65 mmHg), as well as the relationship between hypotension and surgical field quality assessed with the Boezaart Score.

Safety and Adverse Event Monitoring: All procedures are routine clinical practices and carry no additional risk to participants. In the event of postoperative impairment of renal function, standard clinical management will be followed, including fluid optimization and nephrology consultation when appropriate.

Data Confidentiality: All collected data will be de-identified and stored securely with restricted access limited to the research team.

Keywords
Permissive Hypotension, Subclinical Kidney Injury, NGAL, Cystatin C, Rhinologic Surgery, Surgical Field Visibility, Boezaart Score
Medical subject headings
Acute Kidney Injury, Hypotension

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in serum NGAL and cystatin C concentrations indicating biomarker-defined subclinical renal stress

    Serum NGAL concentration (ng/mL) measured by ELISA assay and serum cystatin C concentration (mg/L) measured by automated nephelometric assay will be assessed preoperatively and at postoperative 12-24 hours. A relative increase of ≥25% from baseline will be used as an interpretive biomarker threshold, primarily for NGAL and more cautiously for cystatin C.

    Measured: Preoperative baseline to postoperative 12-24 hours

Secondary outcomes (4)
  1. Duration of mean arterial pressure below 60 mmHg during anesthesia

    The total duration (minutes) of intraoperative mean arterial pressure (MAP) <60 mmHg recorded at 5-minute intervals from standard anesthesia monitoring.

    Measured: Intraoperative period

  2. Duration of mean arterial pressure below 65 mmHg during anesthesia

    The total duration (minutes) of intraoperative mean arterial pressure (MAP) <65 mmHg recorded at 5-minute intervals from standard anesthesia monitoring.

    Measured: Intraoperative period

  3. Correlation between intraoperative hypotension duration and renal biomarker changes

    Correlation between cumulative duration of MAP <60 mmHg and <65 mmHg (minutes) and percentage change in serum NGAL (ng/mL) and cystatin C (mg/L) concentrations from baseline.

    Measured: Intraoperative period to postoperative 12-24 hours

  4. Correlation between surgical field quality and intraoperative hypotension

    Correlation between Boezaart Surgical Field Score (0-5 scale) and cumulative duration of MAP <60 mmHg and <65 mmHg (minutes).

    Measured: End of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2026
  2. Study start1 Mar 2025
  3. Primary completion30 May 2025
  4. Study completion30 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
35 participants (actual)
Target duration
2 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT07328620
Sponsor's protocol ID
PerHypGU0820125
Status last verified
Jun 2026
First submitted
25 Dec 2025
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared. Only de-identified, aggregated study results will be made available through scientific publications and presentations.

Publications

  • Salmasi V, Maheshwari K, Yang D, Mascha EJ, Singh A, Sessler DI, Kurz A. Relationship between Intraoperative Hypotension, Defined by Either Reduction from Baseline or Absolute Thresholds, and Acute Kidney and Myocardial Injury after Noncardiac Surgery: A Retrospective Cohort Analysis. Anesthesiology. 2017 Jan;126(1):47-65. doi: 10.1097/ALN.0000000000001432.

    PubMed 27792044
  • Petrova I, Alexandrov A, Vladimirov G, Mateev H, Bogov I, Paskaleva I, Gotcheva N. NGAL as Biomarker of Clinical and Subclinical Damage of Kidney Function after Coronary Angiography. Diagnostics (Basel). 2023 Mar 20;13(6):1180. doi: 10.3390/diagnostics13061180.

    PubMed 36980488
  • Sessler DI, Bloomstone JA, Aronson S, Berry C, Gan TJ, Kellum JA, Plumb J, Mythen MG, Grocott MPW, Edwards MR, Miller TE; Perioperative Quality Initiative-3 workgroup; POQI chairs; Miller TE, Mythen MG, Grocott MP, Edwards MR; Physiology group; Preoperative blood pressure group; Intraoperative blood pressure group; Postoperative blood pressure group. Perioperative Quality Initiative consensus statement on intraoperative blood pressure, risk and outcomes for elective surgery. Br J Anaesth. 2019 May;122(5):563-574. doi: 10.1016/j.bja.2019.01.013. Epub 2019 Feb 27.

    PubMed 30916004
  • Ostermann M, Legrand M, Meersch M, Srisawat N, Zarbock A, Kellum JA. Biomarkers in acute kidney injury. Ann Intensive Care. 2024 Sep 15;14(1):145. doi: 10.1186/s13613-024-01360-9.

    PubMed 39279017
  • Khetpal S, Elias A, Alford J, et al. Anesthesia for rhinoplasty: a summary of clinical considerations, therapeutic modalities, outcomes, and future directions. JCA Adv. 2024;1:100040. doi:10.1016/j.jcadva.2024.100040.

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Kidney Injury and Hypotension, run by Gazi University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in serum NGAL and cystatin C concentrations indicating biomarker-defined subclinical renal stress (time frame: Preoperative baseline to postoperative 12-24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07328620, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.

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