Acute Kidney InjuryNCT06341933
Risk Factors for AKI in Patients Undergoing VATS for Pulmonary Resection
An observational study of Acute Kidney Injury and Surgery, run by Atatürk Chest Diseases and Chest Surgery Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Kidney Injury, Surgery, Lung Cancer
- What is being tested?
- Duration of Surgery, Volume of Fluid in Surgery and Blood Loss
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2024to 15 Dec 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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),
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- 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.
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, 1 recruiting
- Recruiting
Ankara Atatürk Sanatorium Training and Research Hospital
Ankara, Keçiören, 06290
Ali ALAGÖZ, professor, 5079193765 ext. +9, mdalagoz@gmail.com
Fatma ÖZTÜRK YALÇIN, specialist
About this study
Official title: 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.
Read more
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.
- Conditions
- Acute Kidney Injury, Surgery, Lung Cancer
- Being tested
- Duration of Surgery, Volume of Fluid in Surgery, Blood Loss
- Keywords
- Acute Kidney Injury, Lung Cancer, Video Assisted Thoracoscopic Surgery
- Medical subject headings
- Acute Kidney Injury, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duration of SurgeryOther
Total surgery time in minutes
Volume of Fluid in SurgeryOther
Fluid volume given during surgery in ml
Blood LossOther
Blood loss during surgery in ml
| Study group | Role | What they receive |
|---|---|---|
| Acute Kidney Injury (NO) | In the postoperative period, patients with normal renal function. Receives: Other: Duration of Surgery; Other: Volume of Fluid in Surgery; Other: Blood Loss | |
| 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. Receives: Other: Duration of Surgery; Other: Volume of Fluid in Surgery; Other: Blood Loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
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.
Measured: 1 day
Amount of Urine
The amount of urine produced per hour according to the patient's weight
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start15 Apr 2024
- Primary completion15 Jul 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Alagoz, Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
- Investigators
- Ali ALAGÖZ, professor, Principal investigator, Ankara Ataturk Sanatorium Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06341933
- Sponsor's protocol ID
- 2024-BÇEK/41
- Status last verified
- Jan 2025
- First submitted
- 26 Mar 2024
- Last updated
- 30 Jan 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 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Acute Kidney Injury in Patients Undergoing Video-Assisted Thoracoscopic Surgery for Pulmonary Resection: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06341933
- Acronym / sponsor ID
- 2024-BÇEK/41
- Conditions
- Acute Kidney Injury, Surgery, Lung Cancer
- Keywords
- Acute Kidney Injury, Lung Cancer, Video Assisted Thoracoscopic Surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Atatürk Chest Diseases and Chest Surgery Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 2 Apr 2024 (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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute Kidney Injury (NO) | – | Other: Duration of Surgery, Other: Volume of Fluid in Surgery, Other: Blood LossIn the postoperative period, patients with normal renal function. |
| Acute Kidney Injury (YES) | – | Other: Duration of Surgery, Other: Volume of Fluid in Surgery, Other: Blood LossThere 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Duration of SurgeryTotal surgery time in minutes | Other | Acute Kidney Injury (NO), Acute Kidney Injury (YES) |
| Volume of Fluid in SurgeryFluid volume given during surgery in ml | Other | Acute Kidney Injury (NO), Acute Kidney Injury (YES) |
| Blood LossBlood loss during surgery in ml | Other | Acute Kidney Injury (NO), Acute Kidney Injury (YES) |
Primary outcome
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.
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.
Amount of Urine
Time frame: 1 day
The amount of urine produced per hour according to the patient's weight
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 30 Jan 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.
Ali ALAGÖZ, professor principal investigator
Ankara Ataturk Sanatorium Training and Research Hospital
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 Acute Kidney Injury and Surgery, run by Atatürk Chest Diseases and Chest Surgery Training and Research Hospital 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 3 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 30 Jan 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 Ali ALAGÖZ, professor (5079193765 ext. +9, mdalagoz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glomerular Filtration Rate (time frame: 1 day). The study lists 3 primary outcomes in all. 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 30 Jan 2025.