AnesthesiaNCT07015359
Renal Functions in Preeclamptic Pregnant Women Using Neutrophil Gelatinase-associated Lipocalin (NGAL) and Standard Renal Function Tests
An observational study of Anesthesia and Spinal Aneshtesia, run by Nihan Aydin Guzey at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Anesthesia, Spinal Aneshtesia, Acute Kidney Failure
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Jun 2025to 20 Oct 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ankara City Hospital
Ankara, Ankara, 06800
Ankara City Hospital, +905549542106, cahide.gulsen@hotmail.com
About this study
Official 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
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.
Read the 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.
- Conditions
- Anesthesia, Spinal Aneshtesia, Acute Kidney Failure, Spinal Anesthesia Induced Hypotension, Preeclampsia (PE)
- Keywords
- Preeclampsia, Hypotension, NGAL, Creatinine, AKI
- Medical subject headings
- Acute Kidney Injury, Pre-Eclampsia, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before spinal anesthesia and at postoperative 4th hour
Secondary outcomes (9)
Renal Function Parameters Post-Spinal Anesthesia
Evaluation of postoperative serum urea levels to assess renal function in the early postoperative period.
Measured: Postoperative 4th hour
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.
Measured: NGAL measured before and 4 hours after anesthesia; creatinine at 4 hours
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Measurements recorded at 2, 4, 6, 8, 10, 12, 14, 20, 25, 30, 35, 40, 50, and 55 minutes after spinal anesthesia initiation.
Renal Function Parameters Post-Spinal Anesthesia
Evaluation of postoperative serum creatinine levels to assess renal function in the early postoperative period.
Measured: Postoperative 4th hour
Renal Function Parameters Post-Spinal Anesthesia
Evaluation of postoperative eGFR levels to assess renal function in the early postoperative period.
Measured: Postoperative 4th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start8 Jun 2025 (estimated)
- Primary completion22 Sep 2025 (estimated)
- Study completion20 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 46 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Nihan Aydin Guzey
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara City Hospital Bilkent
- Responsible party
- Sponsor-investigator, Nihan Aydin Guzey, Ankara City Hospital Bilkent
- Investigators
- Nihan Aydın Güzey, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07015359
- Sponsor's protocol ID
- TABED 2/170/2024
- Status last verified
- Jun 2025
- First submitted
- 26 May 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07015359
- Acronym / sponsor ID
- TABED 2/170/2024
- Conditions
- Anesthesia, Spinal Aneshtesia, Acute Kidney Failure, Spinal Anesthesia Induced Hypotension, Preeclampsia (PE)
- Keywords
- Preeclampsia, Hypotension, NGAL, Creatinine, AKI
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Nihan Aydin GuzeyUniversity, hospital or other
- Collaborators
- Ankara City Hospital Bilkent
- Study start
- 8 Jun 2025 (estimated)
- Primary completion
- 22 Sep 2025 (estimated)
- Study completion
- 20 Oct 2025 (estimated)
- First posted
- 11 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
9 secondary outcomes
Renal Function Parameters Post-Spinal Anesthesia
Time frame: Postoperative 4th hour
Comparative Timing of NGAL and Creatinine in Detecting AKI
Time frame: NGAL measured before and 4 hours after anesthesia; creatinine at 4 hours
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.
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.
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.
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.
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.
Renal Function Parameters Post-Spinal Anesthesia
Time frame: Postoperative 4th hour
Renal Function Parameters Post-Spinal Anesthesia
Time frame: Postoperative 4th hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nihan Aydın Güzey principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Spinal Aneshtesia, run by Nihan Aydin Guzey at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cahide Çağlayan, Dr (+905547542106, cahide.gulsen@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.