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

January 30, 2024 updated by: Nanjing First Hospital, Nanjing Medical University
The goal of this observational study is to learn about serum and urine metabolome in patients after cardiac surgery.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The main objective of this study is to collect blood and urine samples from patients after cardiac surgery, and to perform metabolomic analysis to find the differential metabolites and their enrichment pathways in AKI patients and non-AKI patients.The secondary objective is to intervene in its enrichment pathway to find ways to improve CSA-AKI.

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Nanjing, China
        • Nanjing First Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

Inclusion Criteria:

  1. Age> 18 years old;
  2. after cardiopulmonary bypass;

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum and urine metabolome studies
Time Frame: January 2025 - December 2025
The preoperative and postoperative metabolomic differences in blood and urine between AKI group and non-AKI group were compared.
January 2025 - December 2025

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing First Hospital, Nanjing Medical University

Investigators

  • Principal Investigator: Chen Wenxiu, Nanjing First Hospital, Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

January 30, 2024

First Submitted That Met QC Criteria

January 30, 2024

First Posted (Estimated)

February 7, 2024

Study Record Updates

Last Update Posted (Estimated)

February 7, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20240123-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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