Citrate Pharmacokinetics and Regional Citrate Anticoagula... | NCT00948558

Studies
Citrate Pharmacokinetics and Regional Citrate Anticoagulation in CRRT

NCT00948558

Sponsor

Huashan Hospital

Status

Unknown status

Last Update Posted

Aug 6, 2009Estimated

Enrollment

40Estimated

Phase

Not provided

Conditions

Acute Kidney Failure With or Without:
MODS
Sepsis
Hepatic Insufficiency

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

Aug 2009

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

Mar 2009

Primary Completion Date

Dec 2010Estimated

Completion Date

Sep 2011Estimated

First Submitted Date

Jul 28, 2009

First Submission Date that Met QC Criteria

Jul 28, 2009

First Posted Date

Jul 29, 2009Estimated

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

Aug 4, 2009

Last Update Posted Date

Aug 6, 2009Estimated

Name	Class
Shanghai Scientific and technology committe	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

To compare the differences of citrate pharmacokinetics in healthy individuals and critically ill patients as well as the influential factors.
To validate a pharmacokinetic model which has been established in a formal paper.
To create a safe and effective RCA-CRRT protocol.

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

Not provided

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

40Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy individuals, none-pregnant
diagnosed with acute renal failure according to RIFLE criteria
ARF with hepatic insufficiency
ARF with MODS or sepsis
within informed consent

Exclusion Criteria:

used drugs with citrate within one week
infused with blood,plasma or platelet or undergone plasma exchange therapy within 48 hours
serious alkalosis with PH>7.55
serious lactic acidosis
not in resuscitation state

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

the subjects will be selected from a university teaching hospital in Shanghai, China.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Feng Ding, Professor	Contact	86-02152888135		ding_feng@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Huashan hospital	Recruiting	Shanghai		200040	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23824037	Derived	Zheng Y, Xu Z, Zhu Q, Liu J, Qian J, You H, Gu Y, Hao C, Jiao Z, Ding F. Citrate Pharmacokinetics in Critically Ill Patients with Acute Kidney Injury. PLoS One. 2013 Jun 18;8(6):e65992. doi: 10.1371/journal.pone.0065992. Print 2013.

ID	Term
D009102	Multiple Organ Failure
D018805	Sepsis
D048550	Hepatic Insufficiency
D016638	Critical Illness
D058186	Acute Kidney Injury

ID	Term
D012769	Shock
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D007239	Infections