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

NCT ID: NCT01039753

Last Updated: 2010-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-07-31

Brief Summary

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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

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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

Conditions

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Acute Kidney Injury

Keywords

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acute kidney injury renal replacement therapy biomarkers

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yung-Ming Chen, Ph.D

Role: CONTACT

Phone: 886-23123456

Email: [email protected]

Facility Contacts

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Yung-Ming Chen, Ph.D

Role: primary

Other Identifiers

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200912015R

Identifier Type: -

Identifier Source: org_study_id