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Renal Functions in Preeclamptic Pregnant Women Using Neutrophil Gelatinase-associated Lipocalin (NGAL) and Standard Renal Function Tests

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07015359
Enrollment
46
Registered
2025-06-11
Start date
2025-06-08
Completion date
2025-10-20
Last updated
2025-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Failure, Anesthesia, Preeclampsia (PE), Spinal Aneshtesia, Spinal Anesthesia Induced Hypotension

Keywords

Preeclampsia, Hypotension, NGAL, Creatinine, AKI

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.

Interventions

None listed

Sponsors

Ankara City Hospital Bilkent
CollaboratorOTHER
Nihan Aydin Guzey
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
ID: TABED 2/170/2024 Change in Plasma NGAL Levels Before and After Spinal AnesthesiaBefore spinal anesthesia and at postoperative 4th hourTo 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.

Secondary

MeasureTime frameDescription
Renal Function Parameters Post-Spinal AnesthesiaPostoperative 4th hourEvaluation of postoperative serum urea levels to assess renal function in the early postoperative period.
Comparative Timing of NGAL and Creatinine in Detecting AKINGAL measured before and 4 hours after anesthesia; creatinine at 4 hoursTo compare the timing of elevation between plasma NGAL and serum creatinine for early detection of acute kidney injury in preeclamptic patients.
Intraoperative Hemodynamic MonitoringMeasurements recorded at 2, 4, 6, 8, 10, 12, 14, 20, 25, 30, 35, 40, 50, and 55 minutes after spinal anesthesia initiation.Measurement of hemodynamic parameter systolic arterial pressure \[SAP\] at specified time points during the operation to evaluate the cardiovascular effects of spinal anesthesia in preeclamptic patients.

Other

MeasureTime frameDescription
Incidence of Spinal Anesthesia-Related HypotensionWithin the first 30 minutes after spinal anesthesiaNumber and percentage of patients who experience hypotension (defined as a \>20% decrease from baseline systolic blood pressure) following spinal anesthesia.
Total Intraoperative Vasopressor RequirementIntraoperative periodotal dose of vasopressors (e.g., ephedrine or phenylephrine) administered to treat spinal-induced hypotension.

Countries

Turkey (Türkiye)

Contacts

Primary ContactCahide Çağlayan, Dr
cahide.gulsen@hotmail.com+905547542106
Backup ContactNihan Aydın Güzey
nihanaydinguzey@gmail.com+905056496231

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026