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Hypotension During SurgeryNCT07662577

Controlled Hypotension and Renal Injury During Septoplasty

A study of Hypotension During Surgery and NGAL, run by Fatih Sultan Mehmet Training and Research Hospital 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 prospective randomized single-blind study investigated the effects of two different mean arterial pressure (MAP) targets during controlled hypotension on renal injury in patients undergoing septoplasty. Participants were randomized to a low MAP target group (50-57 mmHg) or a higher MAP target group (58-65 mmHg). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Hypotension During Surgery, NGAL, Kidney Injury
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 May 2019to 1 Aug 2020
Phase
Interventional
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults aged 18 to 65 years
  • Scheduled for elective septoplasty under general anesthesia
  • American Society of Anesthesiologists (ASA) physical status I-II
  • Planned controlled hypotension during surgery
  • Provided written informed consent

Who cannot join

  • Body mass index (BMI) > 35 kg/m²
  • History of hypertension
  • Diabetes mellitus
  • Coronary artery disease
  • Cerebrovascular disease
  • Carotid artery stenosis
Show all 11Show fewer
  • Vertebrobasilar insufficiency
  • Pre-existing renal dysfunction
  • Anemia
  • Hypovolemia
  • Refusal to participate in the study

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • FSMTRH

    Istanbul, Ataşehir, 34752

Other trials in Turkey (Türkiye)

About this study

Official title: Effects of Two Different Mean Arterial Pressure Targets During Controlled Hypotension on Renal Injury Assessed by NGAL Levels in Patients Undergoing Septoplasty

This prospective randomized single-blind study investigated the effects of two different mean arterial pressure (MAP) targets during controlled hypotension on renal injury in patients undergoing septoplasty. Participants were randomized to a low MAP target group (50-57 mmHg) or a higher MAP target group (58-65 mmHg). Renal injury was assessed using plasma neutrophil gelatinase-associated lipocalin (NGAL) levels measured at baseline, 6 hours, and 24 hours postoperatively.

Read the detailed description

Controlled hypotension is frequently used during septoplasty to reduce intraoperative bleeding and improve surgical field visibility. However, excessive reductions in mean arterial pressure (MAP) may impair renal perfusion and potentially contribute to postoperative kidney injury. Traditional markers of renal dysfunction, such as serum creatinine, may not detect early renal injury. Neutrophil gelatinase-associated lipocalin (NGAL) has emerged as a sensitive biomarker for the early detection of acute kidney injury.

This prospective randomized study was designed to evaluate the effects of two different MAP target ranges during controlled hypotension on renal injury in patients undergoing elective septoplasty under general anesthesia. Patients were randomly assigned to one of two groups: a lower MAP target group (50-57 mmHg) and a higher MAP target group (58-65 mmHg). Controlled hypotension was achieved according to standard anesthetic practice throughout surgery.

Renal injury was assessed by measuring plasma NGAL concentrations preoperatively and at predetermined postoperative time points. Additional renal function parameters, including serum creatinine levels, urine output, and acute kidney injury classifications, were evaluated. Intraoperative hemodynamic variables and renal regional oxygen saturation values were also recorded.

The primary objective of the study was to determine whether different levels of controlled hypotension influence early renal injury as assessed by NGAL measurements. Secondary objectives included evaluation of conventional renal function parameters, renal tissue oxygenation, and perioperative hemodynamic outcomes.

Being tested
Controlled Hypotension (MAP 50-57 mmHg), Controlled Hypotension (MAP 58-65 mmHg)
Keywords
NGAL, Kidney Injury, Hypotension, NIRS
Medical subject headings
Hypotension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Controlled Hypotension (MAP 50-57 mmHg)Procedure or surgery

    Controlled hypotension was maintained intraoperatively with a target MAP range of 50-57 mmHg according to the study protocol.

  • Controlled Hypotension (MAP 58-65 mmHg)Procedure or surgery

    Controlled hypotension was maintained intraoperatively with a target MAP range of 58-65 mmHg according to the study protocol.

Study groups in NCT07662577
Study groupRoleWhat they receive
Low MAP GroupExperimentalParticipants underwent controlled hypotension during septoplasty with a target mean arterial blood (MAP) range 50-57mmHg.
Receives: Procedure: Controlled Hypotension (MAP 50-57 mmHg)
High MAP GroupExperimentalParticipants underwent controlled hypotension during septoplasty with a target MAP range of 58-65 mmHg according to the study protocol.
Receives: Procedure: Controlled Hypotension (MAP 58-65 mmHg)

What is being measured

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

  1. Plasma Neutrophil Gelatinase-Associated Lipocalin (NGAL) concentration

    Plasma NGAL concentrations were measured to assess early renal injury associated with different target mean arterial pressure ranges during controlled hypotension.

    Measured: After anesthesia induction as a baseline, 6 hours and 24 hours post-induction

Secondary outcomes (4)

  1. Serum Creatinine Concentration

    Serum Creatinine levels were measured to evaluate postoperatinve renal function.

    Measured: After anesthesia induction as a baseline, 6 hours and 24 hours post-induction

  2. Acute Kidney Injury Network (AKIN) Classification

    AKIN scores were determined using serum creatinine measurements and calculated urine output values obtained during the first 24 postoperative hours.

    Measured: After anesthesia induction 6,12 and 24th hours

  3. Urine Output

    Urine volumes were collected in separate containers during the first 6 hours, the second 6 hours, and the subsequent 12 hours following anesthesia induction. Hourly urine output per kilogram body weight was calculated for the 0-6, 0-12, and 0-24 hour periods.

    Measured: 0-6 hours, 6-12 hours, and 12-24 hours after anesthesia induction

  4. Renal Regional Oxygen Saturation (rSO₂)

    Renal regional oxygen saturation (rSO₂) was measured using near-infrared spectroscopy (NIRS) to evaluate the effects of different controlled hypotension targets on renal tissue oxygenation during septoplasty.

    Measured: Throughout surgery and at predefined intraoperative measurement time points

Timeline

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

  1. First posted23 Jun 2026
  2. Study start1 May 2019
  3. Primary completion1 May 2020
  4. Study completion1 Aug 2020

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants were randomized to one of two parallel groups receiving controlled hypotension with different target MAP ranges (50-57 mmHg or 58-65 mmHg) during septoplasty.
Masking
Single blind
Who is masked
Participant
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07662577
Sponsor's protocol ID
FSMKAEK-2019/51
Status last verified
Jun 2026
First submitted
13 Jun 2026
Last updated
23 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Khanna AK, Maheshwari K, Mao G, Liu L, Perez-Protto SE, Chodavarapu P, Schacham YN, Sessler DI. Association Between Mean Arterial Pressure and Acute Kidney Injury and a Composite of Myocardial Injury and Mortality in Postoperative Critically Ill Patients: A Retrospective Cohort Analysis. Crit Care Med. 2019 Jul;47(7):910-917. doi: 10.1097/CCM.0000000000003763.

    PubMed 30985388

  • Hoste EA, Kellum JA. RIFLE criteria provide robust assessment of kidney dysfunction and correlate with hospital mortality. Crit Care Med. 2006 Jul;34(7):2016-7. doi: 10.1097/01.CCM.0000219374.43963.B5. No abstract available.

    PubMed 16801870

  • Murkin JM, Arango M. Near-infrared spectroscopy as an index of brain and tissue oxygenation. Br J Anaesth. 2009 Dec;103 Suppl 1:i3-13. doi: 10.1093/bja/aep299.

    PubMed 20007987

  • Soni SS, Cruz D, Bobek I, Chionh CY, Nalesso F, Lentini P, de Cal M, Corradi V, Virzi G, Ronco C. NGAL: a biomarker of acute kidney injury and other systemic conditions. Int Urol Nephrol. 2010 Mar;42(1):141-50. doi: 10.1007/s11255-009-9608-z. Epub 2009 Jul 7.

    PubMed 19582588

  • Haase M, Bellomo R, Devarajan P, Schlattmann P, Haase-Fielitz A; NGAL Meta-analysis Investigator Group. Accuracy of neutrophil gelatinase-associated lipocalin (NGAL) in diagnosis and prognosis in acute kidney injury: a systematic review and meta-analysis. Am J Kidney Dis. 2009 Dec;54(6):1012-24. doi: 10.1053/j.ajkd.2009.07.020. Epub 2009 Oct 21.

    PubMed 19850388

  • Haase M, Devarajan P, Haase-Fielitz A, Bellomo R, Cruz DN, Wagener G, Krawczeski CD, Koyner JL, Murray P, Zappitelli M, Goldstein SL, Makris K, Ronco C, Martensson J, Martling CR, Venge P, Siew E, Ware LB, Ikizler TA, Mertens PR. The outcome of neutrophil gelatinase-associated lipocalin-positive subclinical acute kidney injury: a multicenter pooled analysis of prospective studies. J Am Coll Cardiol. 2011 Apr 26;57(17):1752-61. doi: 10.1016/j.jacc.2010.11.051.

    PubMed 21511111

  • 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

Questions about this trial

What is this clinical trial studying?

A study of Hypotension During Surgery and NGAL, run by Fatih Sultan Mehmet Training and Research Hospital 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 11 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 23 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?

Plasma Neutrophil Gelatinase-Associated Lipocalin (NGAL) concentration (time frame: After anesthesia induction as a baseline, 6 hours and 24 hours post-induction). 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 NCT07662577, which also lists 7 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 23 Jun 2026.

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