NCT04317196

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,206

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 23, 2020

Completed
9 days until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

May 12, 2020

Status Verified

July 1, 2019

Enrollment Period

1.7 years

First QC Date

November 26, 2019

Last Update Submit

May 9, 2020

Conditions

Acute Kidney Injury

Outcome Measures

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

    48 hours

Secondary Outcomes (2)

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

    3 months

  • Glomerular Filtration Rate(GFR)

    90 days

Eligibility Criteria

Age1 Month - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2019

First Posted

March 23, 2020

Study Start

April 1, 2020

Primary Completion

December 1, 2021

Study Completion

September 1, 2022

Last Updated

May 12, 2020

Record last verified: 2019-07

Locations

CN(1)