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Citrate Pharmacokinetics and Regional Citrate Anticoagulation in CRRT

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ClinicalTrials.gov Identifier: NCT00948558
Recruitment Status : Unknown
Verified August 2009 by Huashan Hospital.
Recruitment status was:  Recruiting
First Posted : July 29, 2009
Last Update Posted : August 6, 2009
Sponsor:
Collaborator:
Information provided by:

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

Condition or disease
Acute Kidney Failure With or Without: MODS Sepsis Hepatic Insufficiency

Study Design

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Citrate Pharmacokinetics in Healthy Individuals and Critically Ill Patients and the Application of Regional Citrate Anticoagulation in Continuous Renal Replacement Therapy(RCA-CRRT).
Study Start Date : March 2009
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
the subjects will be selected from a university teaching hospital in Shanghai, China.
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00948558


Contacts
Contact: Feng Ding, Professor 86-02152888135 ding_feng@hotmail.com

Locations
China
Huashan hospital Recruiting
Shanghai, China, 200040
Contact: Feng Ding, doctor    81-02152888135    ding_feng@hotmail.com   
Sponsors and Collaborators
Huashan Hospital
Shanghai Scientific and technology committe
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Feng Ding, Huashan Hospital
ClinicalTrials.gov Identifier: NCT00948558     History of Changes
Other Study ID Numbers: KY2009-108
First Posted: July 29, 2009    Key Record Dates
Last Update Posted: August 6, 2009
Last Verified: August 2009

Keywords provided by Huashan Hospital:
citrate anticoagulation
pharmacokinetic
critically ill
acute kidney failure

Additional relevant MeSH terms:
Renal Insufficiency
Hepatic Insufficiency
Acute Kidney Injury
Kidney Diseases
Urologic Diseases
Liver Diseases
Digestive System Diseases
Citric Acid
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action