跳至主要内容
临床试验/NCT07015359
NCT07015359尚未招募不适用

Evaluation of the Effect of Spinal Anesthesia-Induced Hypotension on Renal Functions in Preeclamptic Pregnant Women Using Neutrophil Gelatinase-associated Lipocalin (NGAL) and Standard Renal Function Tests

Nihan Aydin Guzey1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2025年6月8日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
46
试验地点
1
主要终点
ID: TABED 2/170/2024 Change in Plasma NGAL Levels Before and After Spinal Anesthesia

研究概览

简要总结

Acute kidney injury (AKI) is a significant postoperative complication. Risk factors for AKI include impaired renal perfusion, decreased functional renal reserve, as well as advanced age, peripheral arterial disease, diabetes mellitus, renovascular disease and congestive heart failure. Mean arterial pressure (MAP) below 55-60 mmHg has been associated with postoperative AKI. Traditional diagnostic criteria for AKI include increased serum creatinine levels and oliguria. However, creatinine levels do not rise until more than half of renal function is lost. Serum and urine NGAL levels rise earlier-within 24-48 hours-making it a promising early biomarker.

In our study, hypotension is defined as systolic blood pressure <100 mmHg or a >30% decrease in MAP. Patients requiring ephedrine under these conditions will be evaluated as the hypotension group and compared with non-hypotensive patients in terms of NGAL, BUN (blood urea nitrogen), creatinine, and GFR (Glomerular Filtration Rate) values at baseline and at the 4th postoperative hour.

详细描述

All patients were informed about the study in the preoperative period and written informed consent was obtained before the procedure. The following data were recorded: age, sex, weight, height, BMI (Body Mass Index), comorbidities, regular medications, ASA (American Society of Anesthesiologists) classification, gestational age, history of preeclampsia in previous pregnancies, hemodynamic values and laboratory results. After being admitted to the cesarean operating room, patients were monitored according to the ASA guidelines using standard monitoring methods (non-invasive arterial blood pressure measurements at 2-minute intervals, 3-lead ECG (Electrocardiogram) and pulse oximetry). A peripheral intravenous line was established via the dorsum of the hand and Ringer's lactate was infused at a rate of 10 mL/kg/h. All patients received oxygen via nasal cannula at a rate of 3-4 L/min.

Blood samples were collected from the patients before spinal anesthesia and at the 4th postoperative hour. The samples were centrifuged at 4000×g for 10 minutes in the biochemistry laboratory and then transferred into Eppendorf tubes and stored at -80°C in a deep freezer until the day of analysis. NGAL levels were measured using an ELISA (Enzyme-Linked ImmunoSorbent Assay) method with a commercial kit (USCN, China) at the Biochemistry Laboratory of Ankara Bilkent City Hospital. Each sample was measured in duplicate, and the mean values were used for evaluation. The intra-assay and inter-assay coefficients of variation (CV%) for the kit were determined to be <10% and <12%, respectively. At the 4th postoperative hour, blood samples were also analyzed for BUN, creatinine, and GFR levels, which were recorded accordingly.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients classified as ASA physical status II-III
  • Pregnant women aged 18-45 years, diagnosed with preeclampsia and scheduled for elective cesarean section, will be included in the study.

排除标准

  • Patients who are unable to read, understand, or sign the informed consent form
  • Patients with a diagnosed renal disease
  • Patients who do not wish to participate in the study
  • Patients with ASA physical status greater than III
  • Patients younger than 18 or older than 45 years
  • Patients requiring sedation or undergoing general anesthesia
  • Patients with cardiac instability
  • Patients with known arrhythmias

结局指标

主要结局

ID: TABED 2/170/2024 Change in Plasma NGAL Levels Before and After Spinal Anesthesia

时间窗: Before spinal anesthesia and at postoperative 4th hour

To assess whether spinal anesthesia-induced hypotension in preeclamptic patients leads to early kidney injury, based on changes in plasma NGAL (neutrophil gelatinase-associated lipocalin) levels.

次要结局

  • Renal Function Parameters Post-Spinal Anesthesia(Postoperative 4th hour)
  • Comparative Timing of NGAL and Creatinine in Detecting AKI(NGAL measured before and 4 hours after anesthesia; creatinine at 4 hours)
  • Intraoperative Hemodynamic Monitoring(Measurements recorded at 2, 4, 6, 8, 10, 12, 14, 20, 25, 30, 35, 40, 50, and 55 minutes after spinal anesthesia initiation.)

研究者

发起方
Nihan Aydin Guzey
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nihan Aydin Guzey

Assoc.Prof. MD

Ankara City Hospital Bilkent

研究点 (1)

Loading locations...

相似试验

Renal Functions in Preeclamptic Pregnant Women Using... | 临床试验