- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02200120
Evaluation of Catheter Placement for Renal Replacement Therapy in Patients With Acute Kidney Injury
July 20, 2015 updated by: Sushrut S Waikar, Brigham and Women's Hospital
Evaluation of Catheter Placement for Renal Replacement Therapy in Patients With Acute Kidney Injury- Assessment of Dialysis Adequacy and Infection Rates
The purpose of this study is to examine the placement, timing, associated complications, efficacy of temporary and tunneled catheters for renal replacement therapy in patient with acute kidney injury.
Study Overview
Status
Completed
Conditions
Detailed Description
The purpose of this study is to examine the placement, timing, associated complications, efficacy of temporary and tunneled catheters for renal replacement therapy in patient with acute kidney injury.
In particular, we will be assessing renal replacement adequacy for patients on dialysis and continuous veno-venous hemofiltration by monitoring urea reduction ratios, venous and arterial pressures.
We will also be monitoring infection rates.
We will compare these outcomes in patients receiving tunneled catheters and patients receiving temporary catheters.
Study Type
Observational
Enrollment (Actual)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Brigham and Women's Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients admitted to the hospital with acute kidney injury requiring renal replacement therapy
Description
Inclusion Criteria:
- Patients admitted to the hospital with acute kidney injury requiring renal replacement therapy
Exclusion Criteria:
- End stage renal disease
- Chronic kidney disease 5 progression to end stage renal disease
- Outside hospital catheter placement
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dialysis adequacy
Time Frame: up to 7d after starting renal replacement therapy
|
Adequacy will be measured using urea reduction ratio for patients on intermittent hemodialysis.
For continuous renal replacement therapy, we will record the maximum blood flow rate achievable.
These measurements/recordings will be made on average within 1-3 days of starting therapy.
|
up to 7d after starting renal replacement therapy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
blood stream infection rates
Time Frame: within 30d of catheter placement
|
Patients will be followed throughout their hospitalization, which can range from a few days to several weeks.
Bloodstream infections within 30d of catheter placement will be recorded.
|
within 30d of catheter placement
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sushrut Waikar, MD, MHS, Brigham and Women's Hospital
- Study Director: Mallika L Mendu, Brigham and Women's Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
July 21, 2014
First Submitted That Met QC Criteria
July 23, 2014
First Posted (Estimate)
July 25, 2014
Study Record Updates
Last Update Posted (Estimate)
July 21, 2015
Last Update Submitted That Met QC Criteria
July 20, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 99904021982
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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