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NCT Number: NCT07662577

Controlled Hypotension and Renal Injury During 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.

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Key information

Conditions

Hypotension During Surgery Cardiovascular Diseases Hypotension Kidney Injury NGAL Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

FSMTRH

Istanbul, Ataşehir, 34752, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Controlled Hypotension (MAP 50-57 mmHg)

Procedure

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

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

Primary outcomes

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

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

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

Secondary outcomes

  1. Serum Creatinine Concentration

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

    Serum Creatinine levels were measured to evaluate postoperatinve renal function.

  2. Acute Kidney Injury Network (AKIN) Classification

    Time frame: After anesthesia induction 6,12 and 24th hours

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

  3. Urine Output

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

    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.

  4. Renal Regional Oxygen Saturation (rSO₂)

    Time frame: Throughout surgery and at predefined intraoperative measurement time points

    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.

Sponsors and collaborators

Lead sponsor

Fatih Sultan Mehmet Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 23, 2026
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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