Citrate Pharmacokinetics and Regional Citrate Anticoagulation in CRRT

Sponsor

Huashan Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT00948558

Collaborator

Shanghai Scientific and technology committe (Other)

Enrollment

Location

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Failure With or Without: MODS Sepsis Hepatic Insufficiency

Study Design

Study Type:

Observational

Anticipated 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 :

Mar 1, 2009

Anticipated Primary Completion Date :

Dec 1, 2010

Anticipated Study Completion Date :

Sep 1, 2011

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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