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NCT Number: NCT07015359

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. Renal Function Parameters Post-Spinal Anesthesia

    Time frame: Postoperative 4th hour

    Evaluation of postoperative serum urea levels to assess renal function in the early postoperative period.

  2. Comparative Timing of NGAL and Creatinine in Detecting AKI

    Time frame: NGAL measured before and 4 hours after anesthesia; creatinine at 4 hours

    To compare the timing of elevation between plasma NGAL and serum creatinine for early detection of acute kidney injury in preeclamptic patients.

  3. Intraoperative Hemodynamic Monitoring

    Time frame: Measurements 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.

  4. Intraoperative Hemodynamic Monitoring

    Time frame: Measurements 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 diastolic arterial pressure [DAP] at specified time points during the operation to evaluate the cardiovascular effects of spinal anesthesia in preeclamptic patients.

  5. Intraoperative Hemodynamic Monitoring

    Time frame: Measurements 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 mean arterial pressure [MAP] at specified time points during the operation to evaluate the cardiovascular effects of spinal anesthesia in preeclamptic patients.

  6. Intraoperative Hemodynamic Monitoring

    Time frame: Measurements 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 heart rate [HR] at specified time points during the operation to evaluate the cardiovascular effects of spinal anesthesia in preeclamptic patients.

  7. Intraoperative Hemodynamic Monitoring

    Time frame: Measurements 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 oxygen saturation [SpO₂] at specified time points during the operation to evaluate the cardiovascular effects of spinal anesthesia in preeclamptic patients.

  8. Renal Function Parameters Post-Spinal Anesthesia

    Time frame: Postoperative 4th hour

    Evaluation of postoperative serum creatinine levels to assess renal function in the early postoperative period.

  9. Renal Function Parameters Post-Spinal Anesthesia

    Time frame: Postoperative 4th hour

    Evaluation of postoperative eGFR levels to assess renal function in the early postoperative period.

Other outcomes

  1. Incidence of Spinal Anesthesia-Related Hypotension

    Time frame: Within the first 30 minutes after spinal anesthesia

    Number and percentage of patients who experience hypotension (defined as a >20% decrease from baseline systolic blood pressure) following spinal anesthesia.

  2. Total Intraoperative Vasopressor Requirement

    Time frame: Intraoperative period

    otal dose of vasopressors (e.g., ephedrine or phenylephrine) administered to treat spinal-induced hypotension.

Study contacts

Contact information is provided by the study sponsor or research team.

Cahide Çağlayan, Dr

CONTACT

[email protected]

+905547542106

Nihan Aydın Güzey

CONTACT

[email protected]

+905056496231

Sponsors and collaborators

Lead sponsor

Nihan Aydin Guzey

Other

Collaborators

  • Ankara City Hospital Bilkent

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 11, 2025
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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