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Status unknownNCT04317196Updated May 12, 2020

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

An observational study in Acute Kidney Injury, sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine. Status unknown at 1 site in China. Open to participants aged 1 Month to 80 Years. Per ClinicalTrials.gov, last updated 2020-05-12.

Sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Observational

The sponsor has not verified this record recently (last verified Jul 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,206
Ages
1 Month to 80 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Acute Kidney Injury
03

In context

Acute Kidney Injury

1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.

This study's planned enrollment of 1,206 is above the median of 150 across 773 observational studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine is the lead sponsor of 222 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Month to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,206 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

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

    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

    Time frame: 48 hours

Secondary outcomes

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

    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

    Time frame: 3 months

  2. Glomerular Filtration Rate(GFR)

    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.

    Time frame: 90 days

07

Study locations

1 of 1 sites recruiting
  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
    Shanghai, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04317196
Lead sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Responsible party
Sponsor
First posted
Mar 23, 2020
Start date
Apr 1, 2020
Primary completion
Dec 1, 2021 (estimated)
Completion
Sep 1, 2022 (estimated)
Last update
May 12, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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