NCT00948558

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

March 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 29, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

August 6, 2009

Status Verified

August 1, 2009

Enrollment Period

1.8 years

First QC Date

July 28, 2009

Last Update Submit

August 4, 2009

Conditions

Acute Kidney Failure With or Without:MODSSepsisHepatic Insufficiency

Keywords

citrate anticoagulationpharmacokineticcritically illacute kidney failure

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huashan hospital

Shanghai, 200040, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 23824037DERIVED

MeSH Terms

Conditions

Multiple Organ FailureSepsisHepatic InsufficiencyCritical IllnessAcute Kidney Injury

Condition Hierarchy (Ancestors)

ShockPathologic ProcessesPathological Conditions, Signs and SymptomsInfectionsSystemic Inflammatory Response SyndromeInflammationLiver DiseasesDigestive System DiseasesDisease AttributesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Central Study Contacts

Feng Ding, Professor

CONTACT

86-02152888135ding_feng@hotmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 28, 2009

First Posted

July 29, 2009

Study Start

March 1, 2009

Primary Completion

December 1, 2010

Study Completion

September 1, 2011

Last Updated

August 6, 2009

Record last verified: 2009-08

Locations

CN(1)