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

May 9, 2020 updated by: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

1206

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
      • Shanghai, China
        • Recruiting
        • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
        • Contact:

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

1 month to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients from Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Description

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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with occurrence of acute kidney injury (AKI) after cardiac surgery
Time Frame: 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
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with occurrence of acute kidney disease (AKD) after cardiac surgery
Time Frame: 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
3 months
Glomerular Filtration Rate(GFR)
Time Frame: 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.
90 days

Collaborators and Investigators

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

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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)

April 1, 2020

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

November 26, 2019

First Submitted That Met QC Criteria

March 19, 2020

First Posted (Actual)

March 23, 2020

Study Record Updates

Last Update Posted (Actual)

May 12, 2020

Last Update Submitted That Met QC Criteria

May 9, 2020

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XHEC-C-2019-111

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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