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

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01039753
• Other study ID #: 200912015R
• Status: Recruiting
• Phase: N/A
• First received: December 24, 2009
• Last updated: January 28, 2010
• Start date: January 2010
• Est. completion date: July 2011

Study information

• Verified date: January 2010
• Source: National Taiwan University Hospital
• Contact: Yung-Ming Chen, Ph.D
• Phone: 886-23123456
• Email: chenym[@]ntuh.gov.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Kidney Injury

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan,