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Recruiting NCT07030179

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

— Observational Postoperative Acute Kidney Injury Frailty

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Frailty status.
Who it may be relevant to
Registry conditions: Postoperative Acute Kidney Injury, Frailty. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

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

Primary outcome measures

  • Postoperative acute kidney injury [Time frame: Within one week after the operation]
Secondary outcome measures (5)
  • 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]

Eligibility criteria

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 surgical procedure is renal surgery
  • The operation time is less than 2 hours

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Zhongda Hospital Southeast University — Nanjing

Identifiers

NCT: NCT07030179 · 2025ZDSYLL201-P01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗