Acute Kidney InjuryNCT06496802
Prognostic Significance of Preoperative Nutritional Status on Postoperative Acute Kidney Injury
An observational study of Acute Kidney Injury and Pneumonectomy, run by Wanmin Liao.
Trial summary
The incidence of postoperative acute kidney injury (AKI) is high in patients undergoing lung resection surgery, especially in the elderly. Early identification of high-risk postoperative AKI patients can help develop prevention and treatment management strategies. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Acute Kidney Injury, Pneumonectomy
- How many people
- 1,880 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to 15 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Older patients (aged ≥ 65 years) who underwent lung resection surgery under general anesthesia at our Hospital between January 2020 and June 2024 were included in our study. Lung resection surgery included pneumonectomy , bilobectomy , lobectomy, segmentectomy, wedge resection/bullectomy.
Who may be able to join
- aged ≥ 65 years
- lung resection surgery including：pneumonectomy , bilobectomy , lobectomy, segmentectomy, wedge resection/bullectomy.
Who cannot join
- patients with an American Society of Anesthesiologists (ASA) physical status V.
- those with end-stage renal disease (i.e. a glomerular filtration rate of 15 mL/min/1.73 m2 or receiving haemodialysis).
- those did not have sufficient data required for nutritional evaluation or AKI evaluation.
About this study
Official title: Prognostic Significance of Preoperative Nutritional Status for Postoperative Acute Kidney Injury in Elderly Patients Undergoing Lung Resection Surgery
The incidence of postoperative acute kidney injury (AKI) is high in patients undergoing lung resection surgery, especially in the elderly. Early identification of high-risk postoperative AKI patients can help develop prevention and treatment management strategies.
Read the detailed description
The goal of this retrospective study is to investigate the predictive value of preoperative nutritional status, as measured by three scoring systems - the geriatric nutritional risk index (GNRI), prognostic nutritional index (PNI), and controlling nutritional status (CONUT) score - on postoperative AKI in elderly patients under lung resection surgery.
- Conditions
- Acute Kidney Injury, Pneumonectomy
- Being tested
- no intervention
- Keywords
- Acute Kidney Injury, lung resection surgery, malnutrition, prediction model
- Medical subject headings
- Acute Kidney Injury, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative acute kidney injury
In accordance with the KDIGO creatinine criteria: a serum creatinine increases of 26.5 mmol/L within 48 hours or 1.5 times baseline within 7 days after surgery.
Measured: Within 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study startJul 2024 (estimated)
- Primary completion15 Sep 2024 (estimated)
- Study completion15 Sep 2024 (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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,880 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wanmin Liao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wanmin Liao, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06496802
- Sponsor's protocol ID
- 101662
- Status last verified
- Jul 2024
- First submitted
- 4 Jul 2024
- Last updated
- 11 Jul 2024
- 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 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Significance of Preoperative Nutritional Status for Postoperative Acute Kidney Injury in Elderly Patients Undergoing Lung Resection Surgery
- ClinicalTrials.gov ID
- NCT06496802
- Acronym / sponsor ID
- 101662
- Conditions
- Acute Kidney Injury, Pneumonectomy
- Keywords
- Acute Kidney Injury, lung resection surgery, malnutrition, prediction model
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,880 participants (estimated)
- Lead sponsor
- Wanmin LiaoUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- 15 Sep 2024 (estimated)
- Study completion
- 15 Sep 2024 (estimated)
- First posted
- 11 Jul 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.
The incidence of postoperative acute kidney injury (AKI) is high in patients undergoing lung resection surgery, especially in the elderly. Early identification of high-risk postoperative AKI patients can help develop prevention and treatment management strategies.
Detailed description
The goal of this retrospective study is to investigate the predictive value of preoperative nutritional status, as measured by three scoring systems - the geriatric nutritional risk index (GNRI), prognostic nutritional index (PNI), and controlling nutritional status (CONUT) score - on postoperative AKI in elderly patients under lung resection surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Older patients (aged ≥ 65 years) who underwent lung resection surgery under general anesthesia at our Hospital between January 2020 and June 2024 were included in our study. Lung resection surgery included pneumonectomy , bilobectomy , lobectomy, segmentectomy, wedge resection/bullectomy.
Key inclusion criteria (2 listed)
- aged ≥ 65 years
- lung resection surgery including：pneumonectomy , bilobectomy , lobectomy, segmentectomy, wedge resection/bullectomy.
Key exclusion criteria (3 listed)
- patients with an American Society of Anesthesiologists (ASA) physical status V.
- those with end-stage renal disease (i.e. a glomerular filtration rate of 15 mL/min/1.73 m2 or receiving haemodialysis).
- those did not have sufficient data required for nutritional evaluation or AKI evaluation.
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 |
|---|---|---|
| no interventionno intervention | Other | – |
Primary outcome
Postoperative acute kidney injury
Time frame: Within 7 days after surgery
In accordance with the KDIGO creatinine criteria: a serum creatinine increases of 26.5 mmol/L within 48 hours or 1.5 times baseline within 7 days after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Pneumonectomy, run by Wanmin Liao.
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 3 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: status not confirmed, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative acute kidney injury (time frame: Within 7 days after surgery). 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 Jul 2024.