Serum and Urine Metabolome Studies in Patients With Acute Kidney Injury After Cardiac Surgery

NCT06245720 | Unknown

• 1 other identifier: KY20240123-01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn about serum and urine metabolome in patients after cardiac surgery.

Conditions

Cardiac Surgery Associated Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• serum and urine metabolome studies

  The preoperative and postoperative metabolomic differences in blood and urine between AKI group and non-AKI group were compared.

  January 2025 - December 2025

Study Arms (2)

AKI group

AKI is then defined as an increase in serum creatinine (SCr) of at least 26.4 μmol/L over 48 hours, or an increase in SCr greater than 1.5 times baseline over 7 days, or a urine output of less than 0.5 mL/kg per hour for more than 6 hours, according to the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines.

Non-AKI group

According to the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines, patients do not develop acute kidney injury.

Eligibility Criteria

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

Study Population

Patients with cardiac surgery who have undergone cardiopulmonary bypass. Acute kidney injury is defined according to the KIDIGO guidelines.

You may qualify if:

• Age\> 18 years old;
• after cardiopulmonary bypass;

You may not qualify if:

• Under the age of 18;
• Previous chronic kidney disease or receiving renal replacement therapy;
• Have a history of kidney transplantation or nephrectomy.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

The serum sample was obtained by collecting blood samples with a serum separation hose containing serum procoagulant, allowing it to coagulate after standing at room temperature for 60min, centrifuging at 3000rmb at 4 °C for 10 min, aspirating the supernatant (i.e., serum 200ul) and dividing it into a suitable numbered 2ml centrifuge tube, liquid nitrogen quick-freezing for 5-10 min, and storage in a -80 °C freezer to avoid repeated freezing and thawing. Urine specimen collection is to use urine in a urine bag, centrifuge at 10000rmb at 4 °C for 10min, aspirate 500ul of supernatant in a numbered 2ml sterile centrifuge tube, liquid nitrogen quick-freeze for 5-10min, and store in a freezer at -80 °C to avoid repeated freezing and thawing.

Study Officials

• Chen Wenxiu

  Nanjing First Hospital, Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 7, 2024
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: February 7, 2024

Record last verified: 2024-01

Locations

CN (1)