Different Crystalloids on AKI in Shock | NCT03155126

Studies
Different Crystalloids on AKI in Shock

NCT03155126

Sponsor

Southeast University, China

Status

Unknown status

Last Update Posted

Jun 14, 2017Actual

Enrollment

600Estimated

Phase

Not provided

Conditions

Shock

Interventions

Fluid resuscitation

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

Jun 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2017Estimated

Primary Completion Date

Jun 2018Estimated

Completion Date

Jul 2018Estimated

First Submitted Date

May 11, 2017

First Submission Date that Met QC Criteria

May 15, 2017

First Posted Date

May 16, 2017Actual

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

Jun 13, 2017

Last Update Posted Date

Jun 14, 2017Actual

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

The goal is to observe that the incidence of acute kidney injury in patients who need fluid resuscitation when resuscitated with saline or acetated Ringer's sodium.

Detailed Description

Fluid resuscitation is important to shock patients. Saline is the classical fluids for resuscitation. However, studies showed that resuscitation with saline could increase the incidence of hyperchloremia and acute kidney injury. Thus, the goal is to observe that the incidence of acute kidney injury in patients who need fluid resuscitation when resuscitated with saline or acetated Ringer's sodium.

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

600Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Saline group		Patients resuscitated with saline	Other: Fluid resuscitation
Acetated Ringer's sodium group		Patients resuscitated with Acetated Ringer's sodium	Other: Fluid resuscitation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fluid resuscitation	Other	Patients in the saline group were resuscitated with saline, patients in the other group were resuscitated with acetated Ringer's sodium	Acetated Ringer's sodium group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of acute kidney injury	Incidence of acute kidney injury	28 day

Secondary Outcomes

Measure	Description	Time Frame
Application of renal replacement	Application of renal replacement	28 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Shock patients who need fluid resuscitation with risk factors of acute kidney injury

Exclusion Criteria:

Patients with a history of chronic kidney injury and hemodialysis therapy

Accepts Healthy Volunteers

Not provided

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

Shock patients who need fluid resuscitation with risk factors of acute kidney injury

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhongda Hospital Southeast University		Nanjing	Jiangsu	210000	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
D012769	Shock
D058186	Acute Kidney Injury

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D051437	Renal Insufficiency
D007674	Kidney Diseases

Browse Leaves

Not provided

Browse Branches

Not provided