Predicting Adverse Kidney Events of Cardiac Surgery-Associated Acute Kidney Injury Using Novel Biomarkers

NCT06351813 | Not Yet Recruiting DMC

• 1 other identifier: B2024-029R
• Study Type: observational
• Target: 358
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to identify and validate novel biomarkers for predict acute kidney injury (AKI) subphenotype, major adverse kidney events and other poor outcomes.

Conditions

Acute Kidney Injury; Critical Illness; Kidney Failure

Outcome Measures

Primary Outcomes (1)

• AKI nonresolving subphenotype

  The resolving subphenotype was defined by a decrease of 0.3 mg/dl or 25% in SCr from its maximum during the first 3 days of study enrollment. All subjects with AKI who did not meet this criterion were classified as having a nonresolving subphenotype

  7 days

Secondary Outcomes (8)

• Major adverse kidney events at 30 days

  30 days

• Major adverse kidney events at 90 days

  90 days

• Major adverse kidney events at 365 days

  365 days

• Mortality

  365 days

• Receipt of renal replacement treatment

  365 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients with age ≥ 18 years who experienced AKI within 48 hours of cardiac surgery were included in this study.

You may qualify if:

• Patients undergoing cardiac surgery who experienced AKI within 48 hours of cardiac surgery were screened.

You may not qualify if:

• History of End Stage Renal Disease or on Dialysis;
• prior kidney transplantation;
• patients with a DNR order;
• patients without written informed consent;
• pregnancy;
• moribund patients with expected death within 24 h or whose survival to 28 days was unlikely due to an uncontrollable comorbidity (i.e., end-stage liver or heart disease, untreatable malignancy)

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• Zhongshan Hospital (Xiamen), Fudan University: collaborator
• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: collaborator

Study Sites (1)

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serial blood and urine samples for biomarker analysis were collected after surgery and then every 6 h in day 1 and then daily until discharge from ICU or for a maximum of 7 days, respectively. Plasma (EDTA), serum, and urine supernatants were frozen within 2 h of sample collection, stored at -80℃, and thawed immediately before analysis.

MeSH Terms

Conditions

Acute Kidney Injury; Critical Illness; Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhe Luo, Professor

  Fudan University

  STUDY DIRECTOR

Central Study Contacts

Ying Su, Dr.

CONTACT

+86-021-64041990; su.ying@zs-hospital.sh.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 8, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 10, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)