Acute Kidney Failure With or Without:NCT00948558
Citrate Pharmacokinetics and Regional Citrate Anticoagulation in CRRT
An observational study of Acute Kidney Failure With or Without: and MODS, run by Huashan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Kidney Failure With or Without:, MODS, Sepsis
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Mar 2009to Sep 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: the subjects will be selected from a university teaching hospital in Shanghai, China.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Huashan hospital
Shanghai, 200040
Feng Ding, doctor, 81-02152888135, ding_feng@hotmail.com
About this study
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).
- 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.
- Keywords
- citrate anticoagulation, pharmacokinetic, critically ill, acute kidney failure
- Medical subject headings
- Multiple Organ Failure, Sepsis, Hepatic Insufficiency, Critical Illness, Acute Kidney Injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2009 (estimated)
- Study startMar 2009
- Primary completionDec 2010 (estimated)
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney Failure With or Without:Studies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Scientific and technology committe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00948558
- Sponsor's protocol ID
- KY2009-108
- Status last verified
- Aug 2009
- First submitted
- 28 Jul 2009
- Last updated
- 6 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23824037
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT00948558
- Acronym / sponsor ID
- KY2009-108
- Keywords
- citrate anticoagulation, pharmacokinetic, critically ill, acute kidney failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Collaborators
- Shanghai Scientific and technology committe
- Study start
- Mar 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 29 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- the subjects will be selected from a university teaching hospital in Shanghai, China.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2009.
- Derived from this study: PubMed 23824037Zheng 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Failure With or Without: and MODS, run by Huashan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Feng Ding, Professor (86-02152888135, ding_feng@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00948558, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2009.