Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01039753
Recruitment Status : Unknown
Verified January 2010 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : December 25, 2009
Last Update Posted : January 29, 2010
Sponsor:
Information provided by:
National Taiwan University Hospital

Tracking Information
First Submitted Date December 24, 2009
First Posted Date December 25, 2009
Last Update Posted Date January 29, 2010
Study Start Date January 2010
Estimated Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Analysis of Clinical Outcomes in Patients Undergoing Acute Dialysis Therapy at Intensive Care Units
Official Title Analysis of Clinical Outcomes in Patients Undergoing Acute Dialysis Therapy at Intensive Care Units
Brief 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. 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.
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

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
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
Sampling Method Probability Sample
Study Population Patients older than 18 years-old and admitted to intensive care units of National Taiwan University Hospital
Condition Acute Kidney Injury
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: December¬†24,¬†2009)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2011
Estimated Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT01039753
Other Study ID Numbers 200912015R
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Yung-Ming Chen, National Taiwan University Hospital
Study Sponsor National Taiwan University Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account National Taiwan University Hospital
Verification Date January 2010