Acute Kidney InjuryNCT01039753
Analysis of Clinical Outcomes in Patients Undergoing Acute Dialysis Therapy at Intensive Care Units
An observational study of Acute Kidney Injury, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Acute kidney injury is more frequent and the mortality rate would be as high as 50-60% when the renal replacement therapy was needed. Many studies about the timing of start and discontinuation of dialysis, dialysis dose, dialyzer, anticoagulation and dialysates were initiated but the results were still controversial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2010to Jul 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients older than 18 years-old and admitted to intensive care units of National Taiwan University Hospital
Who may be able to join
- Patients older than 18 years-old and admitted to intensive care units of National Taiwan University Hospital
Who cannot join
- End stage renal disease
- Terminal disease with estimated life span shorter than 28 days
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 10002
Yung-Ming Chen, Ph.D, 886-23123456 ext. 65993, chenym@ntuh.gov.tw
About this study
Acute kidney injury is more frequent and the mortality rate would be as high as 50-60% when the renal replacement therapy was needed. Many studies about the timing of start and discontinuation of dialysis, dialysis dose, dialyzer, anticoagulation and dialysates were initiated but the results were still controversial. In addition, more new biomarkers were found to predict the outcome of acute kidney injury and these biomarkers may play an important role for the dilemma of aforementioned studies.
This observational prospective study has two objectives:
- To find the predictors of outcome for the acute kidney injury with renal replacement therapy and determine the appropriate method.
- To find the relationship between new biomarkers and acute kidney injury and determine whether it can be a factor for the monitor of the response of the renal replacement therapy.
Read the detailed description
Background:
Acute kidney injury is more frequent than before and the incidence rate was about 35-50% in hospital. The mortality rate would be as high as 50-60% when the renal replacement therapy was needed. Many studies about the timing of start and discontinuation of dialysis, dialysis dose, dialyzer, anticoagulation and dialysates were initiated but the results were still controversial. In addition, more new biomarkers were found to predict the outcome of acute kidney injury and these biomarkers may play an important role for the dilemma of aforementioned studies
Objectives:
- To find the predictors of outcome for the acute kidney injury with renal replacement therapy and determine the appropriate method of renal replacement therapy for acute kidney injury
- To find the relationship between new biomarkers and acute kidney injury and determine whether it can be a factor for the monitor of the response of the renal replacement therapy.
Methods:
- Study duration: 2010/01/01 to 2011/6/30
- Patient eligibility : over 18 years-old and admitted to medical intensive care units of National Taiwan University Hospital
- A prospective study to collect the parameters including underlying diseases, vital signs, biochemistry data, urine output, disease severity scores, dialysis timing, dialysis dose, dialyzer, anticoagulation agents
- Collect serum and urine sample for biomarkers if patient agree
Statistics:
Normally distributed variables are expressed as means ± SDs. Statistical significance is set at P<0.05. All statistical analyses are performed with SAS statistical software. Comparisons between two groups are assessed with the student's unpaired t test and Mann-Whitney test. Differences between more than two groups are analyzed by ANOVA (ANOVA) using one-way ANOVA. Survival analyses are made with the Kaplan-Meier survival curve and the Cox proportional hazard model.
Keywords : acute kidney injury, renal replacement therapy, biomarkers
- Conditions
- Acute Kidney Injury
- Keywords
- acute kidney injury, renal replacement therapy, biomarkers
- Medical subject headings
- 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 posted25 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionJun 2011 (estimated)
- Study completionJul 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01039753
- Sponsor's protocol ID
- 200912015R
- Status last verified
- Jan 2010
- First submitted
- 24 Dec 2009
- Last updated
- 29 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Clinical Outcomes in Patients Undergoing Acute Dialysis Therapy at Intensive Care Units
- ClinicalTrials.gov ID
- NCT01039753
- Acronym / sponsor ID
- 200912015R
- Conditions
- Acute Kidney Injury
- Keywords
- acute kidney injury, renal replacement therapy, biomarkers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jul 2011 (estimated)
- First posted
- 25 Dec 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.
Acute kidney injury is more frequent and the mortality rate would be as high as 50-60% when the renal replacement therapy was needed. Many studies about the timing of start and discontinuation of dialysis, dialysis dose, dialyzer, anticoagulation and dialysates were initiated but the results were still controversial. In addition, more new biomarkers were found to predict the outcome of acute kidney injury and these biomarkers may play an important role for the dilemma of aforementioned studies.
This observational prospective study has two objectives:
- To find the predictors of outcome for the acute kidney injury with renal replacement therapy and determine the appropriate method.
- To find the relationship between new biomarkers and acute kidney injury and determine whether it can be a factor for the monitor of the response of the renal replacement therapy.
Detailed description
Background:
Acute kidney injury is more frequent than before and the incidence rate was about 35-50% in hospital. The mortality rate would be as high as 50-60% when the renal replacement therapy was needed. Many studies about the timing of start and discontinuation of dialysis, dialysis dose, dialyzer, anticoagulation and dialysates were initiated but the results were still controversial. In addition, more new biomarkers were found to predict the outcome of acute kidney injury and these biomarkers may play an important role for the dilemma of aforementioned studies
Objectives:
- To find the predictors of outcome for the acute kidney injury with renal replacement therapy and determine the appropriate method of renal replacement therapy for acute kidney injury
- To find the relationship between new biomarkers and acute kidney injury and determine whether it can be a factor for the monitor of the response of the renal replacement therapy.
Methods:
- Study duration: 2010/01/01 to 2011/6/30
- Patient eligibility : over 18 years-old and admitted to medical intensive care units of National Taiwan University Hospital
- A prospective study to collect the parameters including underlying diseases, vital signs, biochemistry data, urine output, disease severity scores, dialysis timing, dialysis dose, dialyzer, anticoagulation agents
- Collect serum and urine sample for biomarkers if patient agree
Statistics:
Normally distributed variables are expressed as means ± SDs. Statistical significance is set at P<0.05. All statistical analyses are performed with SAS statistical software. Comparisons between two groups are assessed with the student's unpaired t test and Mann-Whitney test. Differences between more than two groups are analyzed by ANOVA (ANOVA) using one-way ANOVA. Survival analyses are made with the Kaplan-Meier survival curve and the Cox proportional hazard model.
Keywords : acute kidney injury, renal replacement therapy, biomarkers
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients older than 18 years-old and admitted to intensive care units of National Taiwan University Hospital
Key inclusion criteria (1 listed)
- Patients older than 18 years-old and admitted to intensive care units of National Taiwan University Hospital
Key exclusion criteria (2 listed)
- End stage renal disease
- Terminal disease with estimated life span shorter than 28 days
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 29 Jan 2010.
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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 Injury, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 inclusion and 2 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 29 Jan 2010. 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 Taiwan. 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 Yung-Ming Chen, Ph.D (886-23123456 ext. 65993, chenym@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 29 Jan 2010.