The Relationship Between Preoperative Frailty and Postoperative AKI and the Mediating Effect of Intraoperative BP

NCT ID: NCT07030179

Last Updated: 2025-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

515 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-01

Study Completion Date

2026-12-31

Brief Summary

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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 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

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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, the incidence of in-hospital complications, the length of hospital stay and the hospitalization costs of the patients were recorded after the operation.

Conditions

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Postoperative Acute Kidney Injury Frailty

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Frailty status

Intervention Type OTHER

This was an observational study with no intervention measures. The exposure factor was the frailty status of the patients.

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.

No interventions assigned to this group

Interventions

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Frailty status

This was an observational study with no intervention measures. The exposure factor was the frailty status of the patients.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 18 years old or above
* Undergo non-cardiac surgery

Exclusion Criteria

* 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 operation time is less than 2 hours
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lanyue Zhu

OTHER

Sponsor Role lead

Responsible Party

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Lanyue Zhu

Attending Doctor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Zhongda Hospital Southeast University

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yue Lan Zhu

Role: CONTACT

+8618795969178

Facility Contacts

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Yue Lan Zhu

Role: primary

+8618795969178

Other Identifiers

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2025ZDSYLL201-P01

Identifier Type: -

Identifier Source: org_study_id

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