An interventional study of Controlled Hypotension (MAP 50-57 mmHg) and Controlled Hypotension (MAP 58-65 mmHg) in Hypotension During Surgery, NGAL and Kidney Injury, sponsored by Fatih Sultan Mehmet Training and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-23.
Sponsored by Fatih Sultan Mehmet Training and Research Hospital · Not applicable, Interventional, and Basic science
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.
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.
1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.
This study's enrollment of 110 is above the median of 80 across 675 interventional studies indexed under Hypotension.
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Exclusion Criteria:
Participants underwent controlled hypotension during septoplasty with a target mean arterial blood (MAP) range 50-57mmHg.
Procedure: Controlled Hypotension (MAP 50-57 mmHg)
Participants underwent controlled hypotension during septoplasty with a target MAP range of 58-65 mmHg according to the study protocol.
Procedure: Controlled Hypotension (MAP 58-65 mmHg)
Controlled hypotension was maintained intraoperatively with a target MAP range of 50-57 mmHg according to the study protocol.
Controlled hypotension was maintained intraoperatively with a target MAP range of 58-65 mmHg according to the study protocol.
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.
Time frame: After anesthesia induction as a baseline, 6 hours and 24 hours post-induction
Serum Creatinine Concentration
Serum Creatinine levels were measured to evaluate postoperatinve renal function.
Time frame: After anesthesia induction as a baseline, 6 hours and 24 hours post-induction
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.
Time frame: After anesthesia induction 6,12 and 24th hours
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.
Time frame: 0-6 hours, 6-12 hours, and 12-24 hours after anesthesia induction
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.
Time frame: Throughout surgery and at predefined intraoperative measurement time points
Plan to share: No
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Fatih Sultan Mehmet Training and Research Hospital