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 volunteersQualifiers
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
Case-control
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Renal Function Parameters Post-Spinal Anesthesia
Evaluation of postoperative serum urea levels to assess renal function in the early postoperative period.
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.
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.
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.
Other outcomes
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.
Total Intraoperative Vasopressor Requirement
otal dose of vasopressors (e.g., ephedrine or phenylephrine) administered to treat spinal-induced hypotension.
Sponsors and contacts
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Nihan Aydin Guzey
Lead sponsor
Ankara City Hospital Bilkent
Sponsor institution
Ankara City Hospital Bilkent
Collaborator
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