How frailty before surgery and blood pressure during the operation relate to kidney injury afterward
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
This will see if adults judged frail before non-cardiac surgery are more likely to get acute kidney injury after the operation and whether drops in blood pressure during surgery explain that link.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zhongda Hospital Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT07030179 on ClinicalTrials.gov |
What this trial studies
This is a single-center prospective cohort of adults undergoing non-cardiac surgery at Zhongda Hospital, enrolling patients between July 2025 and February 2026. Patients will have a frailty assessment within one week before surgery and be grouped as frail or non-frail, with routine recording of intraoperative vital signs, anesthetic drug doses, vasoactive drug use, and fluid balance. Pre- and post-operative serum creatinine and clinical outcomes including postoperative AKI, extubation time, complications, length of stay, and hospitalization costs will be captured. Investigators, including the anesthesiologist managing care, will be unaware of the patient’s frailty status, and mediating-effect analyses will be used to quantify how much intraoperative blood pressure contributes to any frailty–AKI relationship.
Who should consider this trial
Good fit: Adults (≥18) having non-cardiac surgery at Zhongda Hospital who complete pre- and post-op serum creatinine testing and a preoperative frailty assessment, with procedures lasting two hours or more, are eligible.
Not a fit: Patients with end-stage renal disease on recent dialysis, baseline serum creatinine ≥4.5 mg/dL, recent preoperative AKI, renal surgery, missing frailty assessment, or operations under two hours are unlikely to benefit from the study findings.
Why it matters
Potential benefit: If intraoperative blood pressure is shown to mediate the link between frailty and postoperative AKI, targeted blood pressure management during surgery could reduce AKI risk in frail patients.
How similar studies have performed: Previous observational work has linked frailty and intraoperative hypotension separately to higher postoperative AKI risk, but prospective mediation analyses combining these factors are less common.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nanjing, Jiangsu
- Zhongda Hospital Southeast University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Yue Lan Zhu
- Email: zhulanyue1993@126.com
- Phone: +8618795969178
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.