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Citrate Pharmacokinetics and Regional Citrate Anticoagulation in CRRT

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Huashan Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Shanghai Scientific and technology committe
Information provided by:
Huashan Hospital
ClinicalTrials.gov Identifier:
NCT00948558
First received: July 28, 2009
Last updated: August 4, 2009
Last verified: August 2009
History of Changes
  Purpose
  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
Acute Kidney Failure With or Without:
MODS
Sepsis
Hepatic Insufficiency

Study Type: Observational
Study Design: 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).

Resource links provided by NLM:

MedlinePlus related topics: Sepsis
U.S. FDA Resources

Further study details as provided by Huashan Hospital:

Estimated Enrollment: 40
Study Start Date: March 2009
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Feng Ding, Huashan Hospital
ClinicalTrials.gov Identifier: NCT00948558     History of Changes
Other Study ID Numbers: KY2009-108
Study First Received: July 28, 2009
Last Updated: August 4, 2009
Health Authority: China:Ehtics Committee

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

Additional relevant MeSH terms:
Critical Illness
Acute Kidney Injury
Renal Insufficiency
Sepsis
Hepatic Insufficiency
Disease Attributes
Pathologic Processes
Kidney Diseases
Urologic Diseases
Infection
Systemic Inflammatory Response Syndrome
 Inflammation
Liver Diseases
Digestive System Diseases
Citric Acid
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Chelating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013