Acute Kidney Injury in Patients Hospitalized With COVID-19 | NCT04316299

Studies
Acute Kidney Injury in Patients Hospitalized With COVID-19

NCT04316299

Sponsor

Zhenhua Zen

Status

Completed

Last Update Posted

Mar 30, 2020Actual

Enrollment

287Actual

Phase

Not provided

Conditions

COVID-19
Acute Kidney Injury
Kidney Function

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 26, 2020Actual

Primary Completion Date

Feb 28, 2020Actual

Completion Date

Mar 8, 2020Actual

First Submitted Date

Mar 17, 2020

First Submission Date that Met QC Criteria

Mar 19, 2020

First Posted Date

Mar 20, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2020

Last Update Posted Date

Mar 30, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The kidney may be affected in coronavirus-2019 disease (COVID-19). This study assessed the predictors and outcomes of acute kidney injury (AKI) among individuals with COVID-19.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

287Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AKI		COVID-19 patients with acute kidney injury
non-AKI		COVID-19 patients without acute kidney injury

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of Acute Kidney Injury	the incidence of Acute Kidney Injury	From date of admission until the date of discharge or death from any cause, up to 60 days

Secondary Outcomes

Measure	Description	Time Frame
Rate of Death	death from any cause in the hospital	From date of admission until the date of death from any cause, up to 60 days
the length of hospital stay	days from admission to discharge or death

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

COVID-19 pneumonia patients diagnosed by WHO criteria

Exclusion Criteria:

Patients who were younger than 18 years,
Patients who had undergone renal replacement therapy (RRT) before admission,
Patients whose entire stay lasted for less than 48 hours.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients admitted to Hankou Hospital in Wuhan with confirmed COVID-19 pneumonia from 5th Jan to 28th Feb.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hankou Hospital		Wuhan	Hubei	430000	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D058186	Acute Kidney Injury

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided