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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05507268
Other study ID # PLAGH-AOC-004
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2022
Est. completion date December 30, 2022

Study information

Verified date August 2022
Source Chinese PLA General Hospital
Contact Weidong Mi, PhD
Phone 8613381082966
Email wwdd1962@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Postoperative acute kidney injury is associated increased risk of morbidity and mortality. Older patients are at high risk of developing postoperative acute kidney injury. However, the incidence and associations of postoperative acute kidney injury in older patients are not well understood. This study aims to develop and validate a predictive nomogram for postoperative acute kidney injury in older patients undergoing noncardiac surgery.


Description:

Postoperative acute kidney injury (AKI) affects approximately 2% to 40% of patients undergoing cardiac and major noncardiac surgeries. Older patients are more susceptible to renal impairment than younger patients. However, the incidence and associations of AKI in older patients are rarely understood. Generally, in-depth knowledge of risk factors and thus able to identify patients at high risk to develop postoperative AKI is essential to optimize perioperative prevention and protection strategies. In this retrospective study, the investigators intend to develop and validate a predictive model for postoperative using the identified risk factors. The primary outcome is postoperative AKI, which according to the Kidney Disease: Improving Global Outcomes (KDIGO) criterion, is defined as an absolute increase in serum creatinine of 0.3 mg/dL within 48 hours or a 1.5-fold increase from preoperative baseline within 7 days after surgery.


Recruitment information / eligibility

Status Recruiting
Enrollment 50000
Est. completion date December 30, 2022
Est. primary completion date December 30, 2022
Accepts healthy volunteers No
Gender All
Age group 65 Years to 120 Years
Eligibility Inclusion Criteria: - Patients aged 65 years and older Exclusion Criteria: - Emergency operation - Cardiac surgery - Incomplete data - Incomplete data - Local anesthesia - Preoperative renal failure or requirement for dialysis

Study Design


Related Conditions & MeSH terms


Intervention

Other:
no intervention
no intervention

Locations

Country Name City State
China the First Medical Center of Chinese PLA General Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary acute kidney injury an absolute increase in serum creatinine of 0.3 mg/dl within 48 hours or a 1.5-fold increase from preoperative baseline within 7 days after surgery 7 days after surgery
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