Outcome of Patients Treated With RRT | NCT04405830

Studies
Outcome of Patients Treated With RRT

NCT04405830

Sponsor

Nanjing Medical University

Status

Unknown status

Last Update Posted

Apr 18, 2022Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Acute Kidney Injury
Cardiac Surgery

Interventions

Renal replacement therapy

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

Apr 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2012Actual

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

May 26, 2020

First Submission Date that Met QC Criteria

May 26, 2020

First Posted Date

May 28, 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

Apr 15, 2022

Last Update Posted Date

Apr 18, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hong Liu, : Investigator of Department of Cardiac Surgery, Nanjing Medical UniversityPrincipal Investigator

Lead Sponsor

Nanjing Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

Acute Kidney Injury (AKI) is a common serious complication after cardiac surgery. AKI not only prolongs the hospitalization time of patients undergoing cardiac surgery and increases the cost of treatment, but also is an independent risk factor for postoperative death. The aim of this study is to investigate the outcome of patients treated with renal replacement therapy (RRT), and to evaluate the short-term and long-term outcomes of patients with RRT.

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

2,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Renal replacement therapy	Procedure	Renal replacement therapy (RRT) refers to modalities of treatment that are used to replace the waste filtering functions of a normal kidney.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
All-cause mortality		30 days after Renal replacement therapy

Secondary Outcomes

Measure	Description	Time Frame
ICU Length of Stay (LOS)		from ICU admission to ICU discharge, within 30 days of admission

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Critically ill patients undergoing cardiovascular surgery admitted to intensive care units.
Patients receiving RRT for renal support
Patients over 18 years of age

Exclusion Criteria:

Patients <18 years
Refusal of consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Patients receiving RRT for renal support

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hong Liu, MD	Contact	18801281613		DR.HONGLIU@FOXMAIL.COM
Yong-feng Shao, MD	Contact	02568303100		yfshaojph@sina.com

Overall Officials

Name	Affiliation	Role
Yong-feng Shao, MD	First Hospital Affiliated to Nanjing Medical University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The first affiliated hospital of nanjing medical university	Recruiting	Nanjing	Jiangsu	210029	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
D058186	Acute Kidney Injury

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017582	Renal Replacement Therapy

Ancestor Terms

ID	Term
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided