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Analysis of Clinical Outcomes in Patients Undergoing Acute Dialysis Therapy at Intensive Care Units

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01039753
First received: December 24, 2009
Last updated: January 28, 2010
Last verified: January 2010
History of Changes
  Purpose

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:

  1. To find the predictors of outcome for the acute kidney injury with renal replacement therapy and determine the appropriate method.
  2. 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.

Condition
Acute Kidney Injury

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Analysis of Clinical Outcomes in Patients Undergoing Acute Dialysis Therapy at Intensive Care Units

Resource links provided by NLM:

MedlinePlus related topics: Dialysis
U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Biospecimen Retention:   Samples Without DNA

Collect serum and urine sample for biomarkers at the following timing: start date of renal replacement therapy, discontinuation date of renal replacement therapy, 7 days after discontinuation date of renal replacement therapy. 10ml blood and 10ml urine will be collected at each sampling


Estimated Enrollment: 300
Study Start Date: January 2010
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
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:

  1. 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
  2. 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:

  1. Study duration: 2010/01/01 to 2011/6/30
  2. Patient eligibility : over 18 years-old and admitted to medical intensive care units of National Taiwan University Hospital
  3. 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
  4. 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients older than 18 years-old and admitted to intensive care units of National Taiwan University Hospital

Criteria

Inclusion Criteria:

  • Patients older than 18 years-old and admitted to intensive care units of National Taiwan University Hospital

Exclusion Criteria:

  • End stage renal disease
  • Terminal disease with estimated life span shorter than 28 days
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01039753

Contacts
Contact: Yung-Ming Chen, Ph.D 886-23123456 ext 65993 chenym@ntuh.gov.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10002
Contact: Yung-Ming Chen, Ph.D     886-23123456 ext 65993     chenym@ntuh.gov.tw    
Sponsors and Collaborators
National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: Yung-Ming Chen, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01039753     History of Changes
Other Study ID Numbers: 200912015R
Study First Received: December 24, 2009
Last Updated: January 28, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
acute kidney injury
renal replacement therapy
biomarkers

Additional relevant MeSH terms:
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 22, 2013