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

NCT07030179 | Recruiting

• 1 other identifier: 2025ZDSYLL201-P01
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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, 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.

Conditions

Postoperative Acute Kidney Injury; Frailty

Outcome Measures

Primary Outcomes (1)

• Postoperative acute kidney injury

  Within one week after the operation

Secondary Outcomes (5)

• Intraoperative blood pressure

  During the operation

• Postoperative extubation time

  Perioperative period

• Postoperative complications

  Perioperative period

• Hospital stays

  Perioperative period

• Hospitalization costs

  Perioperative period

Study Arms (2)

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.

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.

Interventions

Frailty status OTHER

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

Frail group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent non-cardiac surgery at Zhongda Hospital Southeast University.

You may qualify if:

• years old or above
• Undergo non-cardiac surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Lanyue Zhu: lead

Study Sites (1)

Zhongda Hospital Southeast University

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yue Lan Zhu

CONTACT

+8618795969178; zhulanyue1993@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Doctor

Study Record Dates

• First Submitted: June 7, 2025
• First Posted: June 22, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

CN (1)