Postoperative Acute Kidney InjuryNCT05945940
Preoperative Nutritional 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
There is a high prevalence of postoperative acute kidney injury (AKI) in patients who undergo intra-abdominal surgery, and it is particularly common in the elderly. Identifying high-risk patients for postoperative AKI early can facilitate the development of preventive and therapeutic management strategies. 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
- 2,977 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2023to 30 Jul 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 major abdominal surgery under general anesthesia at Tongji Hospital between July 2018 and December 2021 were included in our study.
Who may be able to join
- aged ≥ 65 years
- intra-abdominal procedures including gastric, colorectal, pancreatic, prostate, and urinary bladder surgeries, as well as abdominal exploration.
- surgery duration lasting longer than 2 hours.
Who cannot join
- patients with an American Society of Anesthesiologists (ASA) physical status V.
- those with concurrent cardiac or renal surgeries.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognostic Significance of Preoperative Nutritional Status for Postoperative Acute Kidney Injury in Elderly Patients Undergoing Major Abdominal Surgery
There is a high prevalence of postoperative acute kidney injury (AKI) in patients who undergo intra-abdominal surgery, and it is particularly common in the elderly. Identifying high-risk patients for postoperative AKI early can facilitate the development of preventive and therapeutic management strategies.
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 undergoing major abdominal surgery.
- Conditions
- Postoperative Acute Kidney Injury
- Being tested
- no intervention
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 posted14 Jul 2023
- Study start20 Jul 2023
- Primary completion30 Jul 2023
- Study completion30 Jul 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
- 2,977 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rao Sun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rao Sun, Tongji Hospital
- Investigators
- Rao Sun, Dr., Principal investigator, Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05945940
- Sponsor's protocol ID
- TJH-20230608A
- Status last verified
- Oct 2023
- First submitted
- 7 Jul 2023
- Last updated
- 6 Oct 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 6 Oct 2023. 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 Major Abdominal Surgery
- ClinicalTrials.gov ID
- NCT05945940
- Acronym / sponsor ID
- TJH-20230608A
- Conditions
- Postoperative Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,977 participants (actual)
- Lead sponsor
- Rao SunUniversity, hospital or other
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 14 Jul 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.
There is a high prevalence of postoperative acute kidney injury (AKI) in patients who undergo intra-abdominal surgery, and it is particularly common in the elderly. Identifying high-risk patients for postoperative AKI early can facilitate the development of preventive and therapeutic management strategies.
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 undergoing major abdominal 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 major abdominal surgery under general anesthesia at Tongji Hospital between July 2018 and December 2021 were included in our study.
Key inclusion criteria (3 listed)
- aged ≥ 65 years
- intra-abdominal procedures including gastric, colorectal, pancreatic, prostate, and urinary bladder surgeries, as well as abdominal exploration.
- surgery duration lasting longer than 2 hours.
Key exclusion criteria (4 listed)
- patients with an American Society of Anesthesiologists (ASA) physical status V.
- those with concurrent cardiac or renal surgeries.
- 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
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 6 Oct 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.
Rao Sun, Dr. principal investigator
Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
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 6 Oct 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?
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 6 Oct 2023.