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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Postoperative acute kidney injury [Срок оценки: Within one week after the operation]

Вторичные конечные точки (5)

• Intraoperative blood pressure [Срок оценки: During the operation]
• Postoperative extubation time [Срок оценки: Perioperative period]
• Postoperative complications [Срок оценки: Perioperative period]
• Hospital stays [Срок оценки: Perioperative period]
• Hospitalization costs [Срок оценки: Perioperative period]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Zhongda Hospital Southeast University — Нанкин

Идентификаторы

NCT: NCT07030179 · 2025ZDSYLL201-P01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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