Postoperative Acute Kidney InjuryNCT07030179
The Relationship Between Preoperative Frailty and Postoperative AKI and the Mediating Effect of Intraoperative BP
An observational study of Postoperative Acute Kidney Injury and Frailty, run by Lanyue Zhu at 1 site in China.
Trial summary
The primary objectives of study is to compare the difference in the incidence of postoperative AKI between frail and non-frail patients. The secondary objectives of study was to compare the differences in intraoperative blood pressure fluctuations, the incidence and duration of intraoperative hypotension… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Acute Kidney Injury, Frailty
- What is being tested?
- Frailty status
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 31 Dec 2026
- How long will I take part?
- 1 Year
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent non-cardiac surgery at Zhongda Hospital Southeast University.
Who may be able to join
- 18 years old or above
- Undergo non-cardiac surgery
Who cannot join
- At least one measurement of serum creatinine (SCr) was not conducted before and after the operation
- End-stage renal disease (ESRD) that has received dialysis within the past year
- Baseline SCr ≥ 4.5 mg/dl (because the clinical criteria for AKI based on elevated SCr may not be applicable to these patients)
- Acute kidney injury occurred within 7 days before the operation
- No frailty assessment was conducted
- The surgical procedure is renal surgery
- The operation time is less than 2 hours
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210000
Yue Lan Zhu, +8618795969178, zhulanyue1993@126.com
About this study
Official title: The Relationship Between Preoperative Frailty and Postoperative Acute Kidney Injury in Patients Undergoing Non-cardiac Surgery and the Mediating Effect of Intraoperative Blood Pressure: A Prospective Cohort Study
The primary objectives of study is to compare the difference in the incidence of postoperative AKI between frail and non-frail patients. The secondary objectives of study was to compare the differences in intraoperative blood pressure fluctuations, the incidence and duration of intraoperative hypotension, postoperative extubation time, postoperative complications, length of hospital stay and hospitalization expenses between frail and non-frail patients, and use mediating effect analysis to examine the magnitude of the effect of intraoperative blood pressure on postoperative acute kidney injury caused by frailty.
Read the detailed description
This study is a single-center prospective cohort study. It is expected to include patients who meet the inclusion and exclusion criteria from July 2025 to February 2026. The demographic characteristics, laboratory indicators, preoperative comorbidities of the patients will be recorded and frailty assessment will be conducted within one week before the operation. The patients were divided into the frail group and the non-frail group. Record the surgery-related information of the patient on the day of the operation. During the operation, vital signs such as the patient's blood pressure and heart rate were routinely detected. The anesthesiologist adopted an experience-guided anesthesia management approach, and the doctor in charge of anesthesia management was also unaware of the patient's frailty status. Record the indicators such as the dosage of anesthetic drugs during the operation, the duration of surgical anesthesia, the use of vasoactive drugs and the fluid intake and output of the patients. The incidence of AKI, postoperative extubation time, the incidence of in-hospital complications, the length of hospital stay and the hospitalization costs of the patients were recorded after the operation.
- Conditions
- Postoperative Acute Kidney Injury, Frailty
- Being tested
- Frailty status
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frailty statusOther
This was an observational study with no intervention measures. The exposure factor was the frailty status of the patients.
| Study group | Role | What they receive |
|---|---|---|
| Frail group | We chose the Fried Phenotypic Assessment Scale to evaluate the frailty status of the patients. The Fried Frailty Assessment Scale holds that frailty is a syndrome composed of five phenotypes: shrinking, weakness, exhaustion, low physical activity, and slowness. Meeting three or more of these phenotypes indicates a frailty status. Receives: Other: Frailty status | |
| Non-frail group | We used the Fried assessment scale to evaluate the frailty status of patients. Patients who met two or fewer indicators were evaluated as having a non-frailty status. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative acute kidney injury
Measured: Within one week after the operation
Secondary outcomes (5)
Intraoperative blood pressure
Measured: During the operation
Postoperative extubation time
Measured: Perioperative period
Postoperative complications
Measured: Perioperative period
Hospital stays
Measured: Perioperative period
Hospitalization costs
Measured: Perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start1 Jul 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
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
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Lanyue Zhu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lanyue Zhu, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07030179
- Sponsor's protocol ID
- 2025ZDSYLL201-P01
- Status last verified
- Mar 2026
- First submitted
- 7 Jun 2025
- Last updated
- 2 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Preoperative Frailty and Postoperative Acute Kidney Injury in Patients Undergoing Non-cardiac Surgery and the Mediating Effect of Intraoperative Blood Pressure: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07030179
- Acronym / sponsor ID
- 2025ZDSYLL201-P01
- Conditions
- Postoperative Acute Kidney Injury, Frailty
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Lanyue ZhuUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Jun 2025 (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 primary objectives of study is to compare the difference in the incidence of postoperative AKI between frail and non-frail patients. The secondary objectives of study was to compare the differences in intraoperative blood pressure fluctuations, the incidence and duration of intraoperative hypotension, postoperative extubation time, postoperative complications, length of hospital stay and hospitalization expenses between frail and non-frail patients, and use mediating effect analysis to examine the magnitude of the effect of intraoperative blood pressure on postoperative acute kidney injury caused by frailty.
Detailed description
This study is a single-center prospective cohort study. It is expected to include patients who meet the inclusion and exclusion criteria from July 2025 to February 2026. The demographic characteristics, laboratory indicators, preoperative comorbidities of the patients will be recorded and frailty assessment will be conducted within one week before the operation. The patients were divided into the frail group and the non-frail group. Record the surgery-related information of the patient on the day of the operation. During the operation, vital signs such as the patient's blood pressure and heart rate were routinely detected. The anesthesiologist adopted an experience-guided anesthesia management approach, and the doctor in charge of anesthesia management was also unaware of the patient's frailty status. Record the indicators such as the dosage of anesthetic drugs during the operation, the duration of surgical anesthesia, the use of vasoactive drugs and the fluid intake and output of the patients. The incidence of AKI, postoperative extubation time, the incidence of in-hospital complications, the length of hospital stay and the hospitalization costs of the patients were recorded after the operation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Frail group | – | Other: Frailty statusWe chose the Fried Phenotypic Assessment Scale to evaluate the frailty status of the patients. The Fried Frailty Assessment Scale holds that frailty is a syndrome composed of five phenotypes: shrinking, weakness, exhaustion, low physical activity, and slowness. Meeting three or more of these phenotypes indicates a frailty status. |
| Non-frail group | – | –We used the Fried assessment scale to evaluate the frailty status of patients. Patients who met two or fewer indicators were evaluated as having a non-frailty status. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent non-cardiac surgery at Zhongda Hospital Southeast University.
Key inclusion criteria (2 listed)
- 18 years old or above
- Undergo non-cardiac surgery
Key exclusion criteria (7 listed)
- At least one measurement of serum creatinine (SCr) was not conducted before and after the operation
- End-stage renal disease (ESRD) that has received dialysis within the past year
- Baseline SCr ≥ 4.5 mg/dl (because the clinical criteria for AKI based on elevated SCr may not be applicable to these patients)
- Acute kidney injury occurred within 7 days before the operation
- No frailty assessment was conducted
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 |
|---|---|---|
| Frailty statusThis was an observational study with no intervention measures. The exposure factor was the frailty status of the patients. | Other | Frail group |
Primary outcome
Postoperative acute kidney injury
Time frame: Within one week after the operation
5 secondary outcomes
Intraoperative blood pressure
Time frame: During the operation
Postoperative extubation time
Time frame: Perioperative period
Postoperative complications
Time frame: Perioperative period
Hospital stays
Time frame: Perioperative period
Hospitalization costs
Time frame: Perioperative period
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 2 Apr 2026.
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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.
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 and Frailty, run by Lanyue Zhu 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 2 inclusion and 7 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 2 Apr 2026. 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?
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 Yue Lan Zhu (+8618795969178, zhulanyue1993@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative acute kidney injury (time frame: Within one week after the operation). 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 2 Apr 2026.