- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06341933
Risk Factors for AKI in Patients Undergoing VATS for Pulmonary Resection
Risk Factors for Acute Kidney Injury in Patients Undergoing Video-Assisted Thoracoscopic Surgery for Pulmonary Resection: A Prospective Observational Study
This study aims to investigate the potential factors contributing to the development of Acute Kidney Injury (AKI) in patients undergoing pulmonary resection with Video Assisted Thoracoscopic Surgery (VATS) for lung malignancy. The study will focus on demographic data, laboratory parameters, perioperative fluid management, and haemodynamics.
The research will be conducted at SBÜ Ankara Atatürk Sanatorium Training and Research Hospital. The study will involve patients who have given informed consent and will undergo VATS with standard anaesthesia monitoring. Anaesthesia management will follow our routine protocol in our clinic.
Patients will be divided into two groups based on whether they have a more than 25% decrease in estimated glomerular filtration rate (t-GFH) and/or a 1.5-fold increase in serum creatinine and/or a 6-hour urine volume of less than 0.5 ml/kg/h. The patients will be divided into two groups based on this definition, and the risk factors between these groups will be analysed.
The preoperative routine blood values, demographic data (age, gender, height, weight, and BMI), ASA physical status, smoking and alcohol habits, comorbidities, and regular medication use will be recorded. Intraoperative urine output and haemodynamic parameters will also be monitored. Routine blood gas analysis, blood urea nitrogen (BUN), glomerular filtration rate (GFR), albumin, haemoglobin, sodium, potassium, chlorine, and magnesium will be measured and recorded, along with urine output and t-GFH. Patients will be evaluated in the hospital on the day the surgeon calls for a postoperative check-up and on the 30th postoperative day to see if there are any complications.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ali ALAGÖZ, professor
- Phone Number: +9 5079193765
- Email: mdalagoz@gmail.com
Study Locations
-
-
Keçiören
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Ankara, Keçiören, Turkey, 06290
- Ankara Atatürk Sanatorium Training and Research Hospital
-
Contact:
- Ali ALAGÖZ, professor
- Phone Number: +9 5079193765
- Email: mdalagoz@gmail.com
-
Sub-Investigator:
- Onur KÜÇÜK, specialist
-
Sub-Investigator:
- Fatma ÖZTÜRK YALÇIN, specialist
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Over 18 years of age, under 65 years of age,
- American Society of Anesthesiologists (ASA) physical status 1-3,
- Data of patients who will undergo wedge resection, segmentectomy or lobectomy with elective VATS due to lung malignancy will be examined prospectively.
Exclusion Criteria:
- Patients with a body mass index (BMI) less than 18.5kg/m2 or greater than 35 kg/m2,
- Those with impaired renal function (the upper limit of the creatinine reference range is more than 50%; 1.3 mg/dL for men and 1.1 mg/dL for women),
- A radiological examination was performed using radiocontrast material in the preoperative period,
- Clinically and radiologically diagnosed with congestive heart failure and treatment has been started,
- Having a history of pulmonary edema,
- Those who have used steroids and non-steroidal anti-inflammatory drugs for a long time (exceeding 30 days),
- Intubated to intensive care unit,
- In need of massive peroperative blood transfusion,
- Patients with deficiencies in the parameters examined will be excluded from the study.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Acute Kidney Injury (NO)
In the postoperative period, patients with normal renal function.
|
Total surgery time in minutes
Fluid volume given during surgery in ml
Blood loss during surgery in ml
|
Acute Kidney Injury (YES)
There has been a decrease of more than 25% in the estimated glomerular filtration rate (t-GFH), and/or a 1.5-fold increase in serum creatinine, and/or a 6-hour urine volume of less than 0.5 ml/kg/h.
|
Total surgery time in minutes
Fluid volume given during surgery in ml
Blood loss during surgery in ml
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glomerular Filtration Rate
Time Frame: 1 day
|
Glomerular filtration rate (GFR) is the volume of fluid filtered from the renal (kidney) glomerular capillaries into the Bowman's capsule per unit time.
|
1 day
|
Serum Creatinine
Time Frame: 1 day
|
The creatinine blood test measures the level of creatinine in the blood.
This test is done to see how well your kidneys are working.
Creatinine in the urine can be measured with a urine test.
A measurement of the serum creatinine level is often used to evaluate kidney function.
|
1 day
|
Amount of Urine
Time Frame: 1 day
|
The amount of urine produced per hour according to the patient's weight
|
1 day
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ali ALAGÖZ, professor, Ankara Atatürk Sanatorium Training and Research Hospital
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-BÇEK/41
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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