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

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04317196
• Other study ID #: XHEC-C-2019-111
• Status: Recruiting
• Start date: April 1, 2020
• Est. completion date: September 1, 2022

Study information

• Verified date: July 2019
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1206
• Est. completion date: September 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Wounds and Injuries

Locations

Country	Name	City	State
China	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	48 hours
Secondary	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	3 months
Secondary	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.	90 days