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

NCT07015359 | Not Yet Recruiting

• 1 other identifier: TABED 2/170/2024
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Preeclampsia; Hypotension; NGAL; Creatinine; AKI

Outcome Measures

Primary Outcomes (1)

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

  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.

  Before spinal anesthesia and at postoperative 4th hour

Secondary Outcomes (9)

• 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.

• 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.

• 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.

Other Outcomes (2)

• Incidence of Spinal Anesthesia-Related Hypotension

  Within the first 30 minutes after spinal anesthesia

• Total Intraoperative Vasopressor Requirement

  Intraoperative period

Study Arms (2)

CASE GROUP

During the operation, heart rate (HR) and peripheral oxygen saturation (SpO₂) were continuously monitored. Systolic arterial pressure (SAP), diastolic arterial pressure (DAP), and mean arterial pressure (MAP) were measured and recorded every 2 minutes for the first 15 minutes, then every 5 minutes thereafter. Hypotension was defined as a ≥30% decrease in MAP from baseline or systolic blood pressure \<100 mmHg. Patients who developed hypotension within the first four measurements were included in the hypotension group. Patients who developed hypotension in later measurements were excluded from the study to avoid confusion with bleeding-related hypotension. A 5 mg bolus of ephedrine was administered to raise the MAP to 80% or more of the baseline level within 60 seconds. Surgical duration, amount of fluids administered, duration and number of hypotensive episodes, total dose of ephedrine, estimated blood loss, use of additional uterotonics or tranexamic acid, neonatal weight, and Apgar.

CONTROL GROUP

During the operation, the patient's heart rate (HR) and peripheral oxygen saturation (SpO₂) were continuously monitored. Systolic arterial pressure (SAP), diastolic arterial pressure (DAP), and mean arterial pressure (MAP) were measured and recorded every 2 minutes for the first 15 minutes, and then every 5 minutes thereafter. Patients whose MAP did not decrease by 30% or more from the baseline value were considered the control group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nihan Aydin Guzey: lead
• Ankara City Hospital Bilkent: collaborator

Study Sites (1)

Ankara City Hospital

Ankara, Ankara, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Acute Kidney Injury; Pre-Eclampsia; Hypotension

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hypertension, Pregnancy-Induced; Pregnancy Complications; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Nihan Aydın Güzey

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cahide Çağlayan, Dr

CONTACT

+905547542106; cahide.gulsen@hotmail.com

Nihan Aydın Güzey

CONTACT

+905056496231; nihanaydinguzey@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assoc.Prof. MD

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 11, 2025
• Study Start: June 8, 2025
• Primary Completion: September 22, 2025
• Study Completion: October 20, 2025
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)