Risk Factors for AKI in Patients Undergoing VATS for Pulmonary Resection

Lung Cancer Clinical Trial

Official title:

Risk Factors for Acute Kidney Injury in Patients Undergoing Video-Assisted Thoracoscopic Surgery for Pulmonary Resection: A Prospective Observational Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06341933
• Other study ID #: 2024-BÇEK/41
• Status: Not yet recruiting
• Start date: April 15, 2024
• Est. completion date: April 15, 2025

Study information

• Verified date: March 2024
• Source: Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
• Contact: Ali ALAGÖZ, professor
• Phone: 5079193765
• Email: mdalagoz[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: April 15, 2025
• Est. primary completion date: December 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Lung Cancer
• Surgery

Intervention

Other:
• Duration of Surgery
Total surgery time in minutes
• Volume of Fluid in Surgery
Fluid volume given during surgery in ml
• Blood Loss
Blood loss during surgery in ml

Locations

Country	Name	City	State
Turkey	Ankara Atatürk Sanatorium Training and Research Hospital	Ankara	Keçiören

Sponsors (1)

Lead Sponsor	Collaborator
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glomerular Filtration Rate	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
Primary	Serum Creatinine	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
Primary	Amount of Urine	The amount of urine produced per hour according to the patient's weight	1 day