Acute Kidney InjuryNCT02200120
Evaluation of Catheter Placement for Renal Replacement Therapy in Patients With Acute Kidney Injury
An observational study of Acute Kidney Injury, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients admitted to the hospital with acute kidney injury requiring renal replacement therapy
Who may be able to join
- Patients admitted to the hospital with acute kidney injury requiring renal replacement therapy
Who cannot join
- End stage renal disease
- Chronic kidney disease 5 progression to end stage renal disease
- Outside hospital catheter placement
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02215
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Kidney Injury
- Medical subject headings
- Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Dialysis adequacy
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.
Measured: up to 7d after starting renal replacement therapy
Secondary outcomes (1)
blood stream infection rates
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.
Measured: within 30d of catheter placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startJan 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sushrut S Waikar, Brigham and Women's Hospital
- Investigators
- Sushrut Waikar, MD, MHS, Principal investigator, Brigham and Women's HospitalMallika L Mendu, Study director, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02200120
- Sponsor's protocol ID
- 99904021982
- Status last verified
- Jul 2015
- First submitted
- 21 Jul 2014
- Last updated
- 21 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Catheter Placement for Renal Replacement Therapy in Patients With Acute Kidney Injury- Assessment of Dialysis Adequacy and Infection Rates
- ClinicalTrials.gov ID
- NCT02200120
- Acronym / sponsor ID
- 99904021982
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 25 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients admitted to the hospital with acute kidney injury requiring renal replacement therapy
Key inclusion criteria (1 listed)
- Patients admitted to the hospital with acute kidney injury requiring renal replacement therapy
Key exclusion criteria (3 listed)
- End stage renal disease
- Chronic kidney disease 5 progression to end stage renal disease
- Outside hospital catheter placement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
blood stream infection rates
Time frame: within 30d of catheter placement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sushrut Waikar, MD, MHS principal investigator
Brigham and Women's Hospital
Mallika L Mendu study director
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dialysis adequacy (time frame: up to 7d after starting renal replacement therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2015; AzTrials last refreshed its copy on 7 Nov 2026.