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NCT Number: NCT07030179

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongda Hospital Southeast University

Nanjing, Jiangsu, 210000, China

Location status: Recruiting

Location contact

Yue Lan Zhu

CONTACT

[email protected]

+8618795969178

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Frailty status

Other

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

Primary outcomes

  1. Postoperative acute kidney injury

    Time frame: Within one week after the operation

Secondary outcomes

  1. Intraoperative blood pressure

    Time frame: During the operation

  2. Postoperative extubation time

    Time frame: Perioperative period

  3. Postoperative complications

    Time frame: Perioperative period

  4. Hospital stays

    Time frame: Perioperative period

  5. Hospitalization costs

    Time frame: Perioperative period

Study contacts

Contact information is provided by the study sponsor or research team.

Yue Lan Zhu

CONTACT

[email protected]

+8618795969178

Sponsors and collaborators

Lead sponsor

Lanyue Zhu

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 22, 2025
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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