NCT03061786

Brief Summary

Acute kidney injury (AKI) is a common clinical syndrome, especially in the hospital patients. AKI is recognized as an important risk factor for incident chronic kidney disease, accelerated progression to end-stage renal disease,and increased risk of short-term and long-term mortality.This study is to observe the prognosis of hospitalized patients with AKI in China.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,000,000

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Jan 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Jan 2017Dec 2027

Study Start

First participant enrolled

January 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
10.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

December 13, 2022

Status Verified

December 1, 2022

Enrollment Period

10.9 years

First QC Date

February 15, 2017

Last Update Submit

December 10, 2022

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (4)

  • estimated glomerular filtration rate decline

    \>50% baseline

    2 years

  • Chronic kidney disease classification upgrade

    5 years

  • New cardiovascular events

    5 years

  • All-cause mortality

    5 years

Secondary Outcomes (2)

  • AKI recovery

    5 years

  • Rehospitalization

    5 years

Study Arms (2)

AKI

non-AKI

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Hospitalized patients

You may qualify if:

  • clinically diagnosed with acute kidney injury, according to KDIGO criteria

You may not qualify if:

  • Nephrectomy
  • Kidney transplantation
  • Peak serum creatinine of less than 53µ mol/L
  • Serum creatinine decrease after amputation
  • Patients died during hospitalization
  • End-stage kidney disease(chronic kidney disease stage 5)
  • malnutrition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong General Hospital

Guangzhou, Guangdong, 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

Central Study Contacts

Liang Xinling, MD,PhD

CONTACT

86-13808819770xinlingliang@139.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Division of Nephrology and Blood Purification Center of Guangdong General Hospital

Study Record Dates

First Submitted

February 15, 2017

First Posted

February 23, 2017

Study Start

January 1, 2017

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

December 13, 2022

Record last verified: 2022-12

Locations

CN(1)