Postoperative Acute Kidney InjuryNCT06027476
Preoperative Inflammatory Status and Postoperative Acute Kidney Injury
An observational study of Postoperative Acute Kidney Injury, run by Rao Sun at 1 site in China.
Trial summary
Acute kidney injury (AKI) is a common complication during the early postoperative period after noncardiac surgery. Patients with AKI are at an increased risk of developing chronic kidney disease, prolonging hospitalization, and experiencing higher rates of morbidity and mortality. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Postoperative Acute Kidney Injury
- How many people
- 8,472 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2023to 5 Oct 2023
- 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: Elderly patients (aged ≥ 65 years) who underwent a non-cardiac surgery at Tongji Hospital between July 2018 and December 2021 were included in our study.
Who may be able to join
- aged ≥ 65 years.
- general, gynaecological, neurosurgery, orthopaedic, or thoracic surgery.
- surgery duration lasting longer than one hour.
Who cannot join
- patients with an American Society of Anesthesiologists (ASA) physical status V.
- those with concurrent cardiac, vascular, transplant or urological surgeries.
- those with end-stage renal disease (i.e. a glomerular filtration rate of 15 mL/min/1.73 m2 or receiving haemodialysis) or a history of kidney transplantation..
- those did not have sufficient data required for calculation for inflammatory markers or AKI evaluation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognostic Significance of Preoperative Inflammatory Status for Postoperative Acute Kidney Injury in Elderly Patients Undergoing Non-cardiac Surgery
Acute kidney injury (AKI) is a common complication during the early postoperative period after noncardiac surgery. Patients with AKI are at an increased risk of developing chronic kidney disease, prolonging hospitalization, and experiencing higher rates of morbidity and mortality. Identifying preoperative risk factors for postoperative AKI can significantly contribute to the development of preventive strategies and improved perioperative care in this vulnerable patient population.
The goal of this retrospective study is to investigate the predictive value of preoperative inflammatory status, as measured by complete blood count-derived inflammatory markers, such as the neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), monocyte-to-lymphocyte ratio (MLR), derived neutrophil-to-lymphocyte ratio (dNLR), neutrophil-to-lymphocyte*platelet ratio (NLPR), systemic immune-inflammatory index (SII), systemic inflammatory response index (SIRI), and aggregate index of systemic inflammation (AISI), on postoperative AKI in elderly patients undergoing non-cardiac surgery.
- Conditions
- Postoperative Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with acute kidney injury 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.
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 posted7 Sep 2023
- Study start10 Sep 2023
- Primary completion1 Oct 2023
- Study completion5 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative 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
- 8,472 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rao Sun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rao Sun, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06027476
- Sponsor's protocol ID
- TJH-20230608B
- Status last verified
- Nov 2023
- First submitted
- 30 Aug 2023
- Last updated
- 22 Nov 2023
- Results posted
- 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 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Significance of Preoperative Inflammatory Status for Postoperative Acute Kidney Injury in Elderly Patients Undergoing Non-cardiac Surgery
- ClinicalTrials.gov ID
- NCT06027476
- Acronym / sponsor ID
- TJH-20230608B
- Conditions
- Postoperative Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,472 participants (actual)
- Lead sponsor
- Rao SunUniversity, hospital or other
- Study start
- 10 Sep 2023 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 5 Oct 2023 (actual)
- First posted
- 7 Sep 2023 (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.
Acute kidney injury (AKI) is a common complication during the early postoperative period after noncardiac surgery. Patients with AKI are at an increased risk of developing chronic kidney disease, prolonging hospitalization, and experiencing higher rates of morbidity and mortality. Identifying preoperative risk factors for postoperative AKI can significantly contribute to the development of preventive strategies and improved perioperative care in this vulnerable patient population.
The goal of this retrospective study is to investigate the predictive value of preoperative inflammatory status, as measured by complete blood count-derived inflammatory markers, such as the neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), monocyte-to-lymphocyte ratio (MLR), derived neutrophil-to-lymphocyte ratio (dNLR), neutrophil-to-lymphocyte*platelet ratio (NLPR), systemic immune-inflammatory index (SII), systemic inflammatory response index (SIRI), and aggregate index of systemic inflammation (AISI), on postoperative AKI in elderly patients undergoing non-cardiac 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
- Elderly patients (aged ≥ 65 years) who underwent a non-cardiac surgery at Tongji Hospital between July 2018 and December 2021 were included in our study.
Key inclusion criteria (3 listed)
- aged ≥ 65 years.
- general, gynaecological, neurosurgery, orthopaedic, or thoracic surgery.
- surgery duration lasting longer than one hour.
Key exclusion criteria (4 listed)
- patients with an American Society of Anesthesiologists (ASA) physical status V.
- those with concurrent cardiac, vascular, transplant or urological surgeries.
- those with end-stage renal disease (i.e. a glomerular filtration rate of 15 mL/min/1.73 m2 or receiving haemodialysis) or a history of kidney transplantation..
- those did not have sufficient data required for calculation for inflammatory markers 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.
Primary outcome
Number of participants with acute kidney injury after surgery
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- 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.
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 Postoperative Acute Kidney Injury, run by Rao Sun at 1 site in China.
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 4 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: finished, as of the sponsor's last update on 22 Nov 2023. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with acute kidney injury after surgery (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 22 Nov 2023.