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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low MAP Group | Experimental | Participants underwent controlled hypotension during septoplasty with a target mean arterial blood (MAP) range 50-57mmHg. |
|
| High MAP Group | Experimental | Participants underwent controlled hypotension during septoplasty with a target MAP range of 58-65 mmHg according to the study protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | After anesthesia induction as a baseline, 6 hours and 24 hours post-induction |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Creatinine Concentration | Serum Creatinine levels were measured to evaluate postoperatinve renal function. | After anesthesia induction as a baseline, 6 hours and 24 hours post-induction |
| Acute Kidney Injury Network (AKIN) Classification |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FSMTRH | Istanbul | Ataşehir | 34752 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30985388 | Background | 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. | |
| 16801870 |
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| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D007023 | Hypotension, Controlled |
| ID | Term |
|---|---|
| D000760 | Anesthesia and Analgesia |
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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.
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| 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. |
|
AKIN scores were determined using serum creatinine measurements and calculated urine output values obtained during the first 24 postoperative hours.
| 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. | 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. | Throughout surgery and at predefined intraoperative measurement time points |
| 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. |
| 20007987 | Background | 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. |
| 19582588 | Background | 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. |
| 19850388 | Background | 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. |
| 21511111 | Background | 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. |
| 27792044 | Background | 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. |