Clinical trial NCT07015359: Renal Functions in Preeclamptic Pregnant Women Using Neutrophil Gelatinase-associated Lipocalin (NGAL) and Standard Renal Function Tests
Official title: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Anesthesia
Spinal Aneshtesia
Acute Kidney Failure
Spinal Anesthesia Induced Hypotension
Preeclampsia (PE)
Keywords: Preeclampsia
Hypotension
NGAL
Creatinine
AKI
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
Collaborators: name: Ankara City Hospital Bilkent
First posted: 2025-06-11
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preeclamptic pregnant women aged 18 to 45 years, classified as ASA II-III, who volunteered to participate, were scheduled for cesarean section, and received spinal anesthesia were included in the study.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: ID: TABED 2/170/2024 Change in Plasma NGAL Levels Before and After Spinal Anesthesia
timeFrame: Before spinal anesthesia and at postoperative 4th hour
Secondary outcomes:
measure: Renal Function Parameters Post-Spinal Anesthesia
timeFrame: Postoperative 4th hour
measure: Comparative Timing of NGAL and Creatinine in Detecting AKI
timeFrame: NGAL measured before and 4 hours after anesthesia; creatinine at 4 hours
measure: Intraoperative Hemodynamic Monitoring
timeFrame: Measurements recorded at 2, 4, 6, 8, 10, 12, 14, 20, 25, 30, 35, 40, 50, and 55 minutes after spinal anesthesia initiation.
measure: Intraoperative Hemodynamic Monitoring
timeFrame: Measurements recorded at 2, 4, 6, 8, 10, 12, 14, 20, 25, 30, 35, 40, 50, and 55 minutes after spinal anesthesia initiation.
measure: Intraoperative Hemodynamic Monitoring
timeFrame: Measurements recorded at 2, 4, 6, 8, 10, 12, 14, 20, 25, 30, 35, 40, 50, and 55 minutes after spinal anesthesia initiation.
measure: Intraoperative Hemodynamic Monitoring
timeFrame: Measurements recorded at 2, 4, 6, 8, 10, 12, 14, 20, 25, 30, 35, 40, 50, and 55 minutes after spinal anesthesia initiation.
measure: Intraoperative Hemodynamic Monitoring
timeFrame: Measurements recorded at 2, 4, 6, 8, 10, 12, 14, 20, 25, 30, 35, 40, 50, and 55 minutes after spinal anesthesia initiation.
measure: Renal Function Parameters Post-Spinal Anesthesia
timeFrame: Postoperative 4th hour
measure: Renal Function Parameters Post-Spinal Anesthesia
timeFrame: Postoperative 4th hour
Other outcomes:
measure: Incidence of Spinal Anesthesia-Related Hypotension
timeFrame: Within the first 30 minutes after spinal anesthesia
measure: Total Intraoperative Vasopressor Requirement
timeFrame: Intraoperative period
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
Study officials:
affiliation: Ankara City Hospital Bilkent
name: Nihan Aydın Güzey
role: PRINCIPAL_INVESTIGATOR
References: