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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorNihan Aydin Guzey

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

46 Participants
are grouped into 2 trial groups
Group A: CASE GROUP
Group B: CONTROL GROUP

Trial outcomes

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.

Time frame
Before spinal anesthesia and at postoperative 4th hour

Secondary outcomes

1

Renal Function Parameters Post-Spinal Anesthesia

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

Time frame
Postoperative 4th hour
2

Comparative Timing of NGAL and Creatinine in Detecting AKI

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

Time frame
NGAL measured before and 4 hours after anesthesia; creatinine at 4 hours
3

Intraoperative Hemodynamic Monitoring

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.

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.
4

Intraoperative Hemodynamic Monitoring

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.

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.

Other outcomes

1

Incidence of Spinal Anesthesia-Related Hypotension

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

Time frame
Within the first 30 minutes after spinal anesthesia
2

Total Intraoperative Vasopressor Requirement

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

Time frame
Intraoperative period

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nihan Aydin Guzey

Lead sponsor

Ankara City Hospital Bilkent

Sponsor institution

Ankara City Hospital Bilkent

Collaborator

This trial is not recruiting at the moment. You can still explore other options: