Citrate Pharmacokinetics and Regional Citrate Anticoagulation in CRRT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Shanghai Scientific and technology committe
Information provided by:
Huashan Hospital

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 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

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.

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

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 identifier (NCT number): NCT00948558

Contact: Feng Ding, Professor 86-02152888135

Huashan hospital Recruiting
Shanghai, China, 200040
Contact: Feng Ding, doctor    81-02152888135   
Sponsors and Collaborators
Huashan Hospital
Shanghai Scientific and technology committe

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Feng Ding, Huashan Hospital 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
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
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action