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Association of Copy Number Variations in the SMN Genes With Acute Kidney Injury After Heart Surgery

Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (Other)
Overall Status
Recruiting
CT.gov ID
NCT04317196
Collaborator
(none)
1,206
Enrollment
1
Location
29
Anticipated Duration (Months)
41.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This prospective cohort study aims to explore the susceptibility to acute kidney injury after heart surgery in SMN1+/- genotype population. This study also aims to analysis the effect of SMN1+/- genotype on postoperative AKI and the development of chronic kidney disease, as well as dose-compensating effect of different copy number of SMN2 gene on SMN1 +/- genotype.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This prospective cohort study aims to explore the susceptibility to acute kidney injury after heart surgery in SMN1+/- genotype population. Real-time PCR is used to detect copy number variations in the peripheral blood SMN gene on 1206 patients with heart surgery. This study also aims to analysis the effect of SMN1+/- genotype on postoperative AKI and the development of chronic kidney disease, as well as dose-compensating effect of different copy number of SMN2 gene on SMN1 +/- genotype.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1206 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Molecular Epidemiology Study of the Association of Copy Number Variations in the SMN Genes With Acute Kidney Injury After Heart Surgery
    Actual Study Start Date :
    Apr 1, 2020
    Anticipated Primary Completion Date :
    Dec 1, 2021
    Anticipated Study Completion Date :
    Sep 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants with occurrence of acute kidney injury (AKI) after cardiac surgery [48 hours]

      The definition of the occurrence of acute kidney injury is according to the acute kidney injury (AKI) definition and staging criteria released by Kidney Disease: Improving Global Outcomes (KDIGO) in the year 2012

    Secondary Outcome Measures

    1. Number of participants with occurrence of acute kidney disease (AKD) after cardiac surgery [3 months]

      The definition of the occurrence of acute kidney disease is according to the acute kidney disease (AKD) definition criteria released by Kidney Disease: Improving Global Outcomes (KDIGO) in the year 2012

    2. Glomerular Filtration Rate(GFR) [90 days]

      Glomerular filtration rate (GFR) is defined as the volume of plasma that is filtered by the glomeruli per unit of time, and is usually measured by estimating the rate of clearance of a substance from the plasma.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Month to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age: Children (1 month -17 years old) and adults (18-80 years old);

    • Sex: All;

    • Those who will receive selective cardiac surgery with cardiopulmonary bypass;

    • Those who signed the informed consent.

    Exclusion Criteria:

    • Those with glomerular filtration rate: eGFR<15ml/min/1.73m2, and those who have received the renal replacement therapy before surgery;

    • Those who have received nephrectomy and kidney transplantation;

    • Those who have suffered from AKI before;

    • Those with incomplete medical history or clinical data.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Xinhua Hospital, Shanghai Jiao Tong University School of Medicine Shanghai China

    Sponsors and Collaborators

    • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT04317196
    Other Study ID Numbers:
    • XHEC-C-2019-111
    First Posted:
    Mar 23, 2020
    Last Update Posted:
    May 12, 2020
    Last Verified:
    Jul 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Acute Kidney Injury
    Wounds and Injuries

    Study Results

    No Results Posted as of May 12, 2020