Clinical trial NCT06341933: Risk Factors for AKI in Patients Undergoing VATS for Pulmonary Resection
Official title: Risk Factors for Acute Kidney Injury in Patients Undergoing Video-Assisted Thoracoscopic Surgery for Pulmonary Resection: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Kidney Injury
Surgery
Lung Cancer
Keywords: Acute Kidney Injury
Lung Cancer
Video Assisted Thoracoscopic Surgery
Lead sponsor: Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Based on the given parameters of a 1/3 patient ratio, two-sided (two-tailed) type I error of 0.05, power of 95%, effect size of 0.86, and group distribution ratio of 3, it was determined that the group with acute kidney injury should include 24 patients and the group without acute kidney injury should include 72 patients. Our study was designed to include an average of 100 patients.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Glomerular Filtration Rate
timeFrame: 1 day
measure: Serum Creatinine
timeFrame: 1 day
measure: Amount of Urine
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Atatürk Sanatorium Training and Research Hospital
state: Keçiören
Study officials:
affiliation: Ankara Ataturk Sanatorium Training and Research Hospital
name: Ali ALAGÖZ, professor
role: PRINCIPAL_INVESTIGATOR
References: