Renal FailureNCT00207909
Study of Patients With Acute Renal Failure on CVVH
An observational study of Renal Failure, run by Children's Healthcare of Atlanta at 1 site in United States.
Trial summary
Acute kidney failure is common in children in the Pediatric Intensive Care Unit (PICU). You are being asked to participate in this study because your child is being treated for kidney failure with continuous veno-venous hemofiltration (CVVH). Read more about this study
- Who is it for?
- Ages 5 months and older
- Conditions the study is for
- Renal Failure
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Mar 2010
- 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 5 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients Pediatric Intensive Care Unit @ Egleston meeting inclusion criteria / avoiding exclusion criteria.
Who may be able to join
- The general goal of patient selection is to enroll all children for whom CVVH is instituted.
- Age
- 6 months -18 years old
- Patients less than 6 months of age on ECMO (addendum #1)
- Indication for CVVH: including, but not limited to :
- Acute Renal Failure
Show all 17Show fewer
- Oliguria
- Anuria
- Hyperkalemia
- Severe acidemia
- Azotemia
- Pulmonary Edema
- Uremic complications
- Severe electrolyte abnormalities
- Drug overdose with a filterable toxin
- Anasarca
- Rhabdomyolysis
Who cannot join
- Age
- Less than 6 months old (unless on ECMO)
- Greater than 18 years old Weight
- Less than 5 kilograms (unless ON ECMO) Location
- Cardiac Intensive Care Unit
- Neonatal Intensive Care Unit
- Non-adherence:
- Inability or unwillingness of the legal guardian to provide consent or inability or unwillingness of the child to provide assent
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, 30322
About this study
Official title: The Role of Hemodynamics, Cytokine Response, and Modulators of Apoptosis on Urine Output in Patients With Acute Renal Failure on CVVH
Acute kidney failure is common in children in the Pediatric Intensive Care Unit (PICU). You are being asked to participate in this study because your child is being treated for kidney failure with continuous veno-venous hemofiltration (CVVH). CVVH is a continuous, gentle form of removing excess fluids and small wastes from the blood, similar to kidney dialysis (artificial kidney). It is an accepted therapy for temporary support of kidney failure. In some patients with acute kidney failure, beginning CVVH is followed by a temporary decrease of urine output. The reason why this happens is currently unknown. The purpose of this study is to determine why this happens.
Read the detailed description
Acute renal failure is common in children in the pediatric intensive care unit. Renal replacement therapies such as peritoneal dialysis (PD), intermittent hemodialysis (IHD), and continuous venovenous hemofiltration (CVVH) have been used in the management of acute renal failure. CVVH is becoming increasingly utilized in pediatric acute renal failure. However, in patients who have acute renal failure, the institution of CVVH is often followed by a progression to oliguria or anuria. The underlying pathophysiology of this change is unknown. We believe that this progression is influenced by changes in the renin-angiotensin axis, cytokine response, and other modifiers of renal hemodynamics. By serially measuring components of those systems, this study will attempt to elucidate the pathophysiology of the decreased urine output seen with institution of CVVH. Once this process is understood, future studies should focus on prevention and treatment of this complication.
General Hypothesis
The decrease in urine output seen after the initiation of CVVH is associated with increased angiotensin converting enzyme (ACE) levels, increased renin activity, increased angiotensin II levels, increased atrial naturetic peptide (ANP) levels, increased endothelin-1 levels, increased arginine vasopressin (AVP) levels, and alterations of cytokine levels and modulators of apoptosis.
- Conditions
- Renal Failure
- Keywords
- Acute Renal Failure, Contiuous Veno Venous Hemofiltration
- Medical subject headings
- Renal Insufficiency, Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the underlying etiology of the decrease in urine output seen with the institution of CVVH by examining patient's physiologic hormonal responses.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startFeb 2005
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal FailureStudies of the same condition, open and under way.
- 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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Healthcare of Atlanta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James D Fortenberry, MD, Principal investigator, Children's Healthcare of Atlanta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00207909
- Sponsor's protocol ID
- 04-114
- Other IDs
- 06585
- Status last verified
- Jun 2016
- First submitted
- 13 Sep 2005
- Last updated
- 14 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Hemodynamics, Cytokine Response, and Modulators of Apoptosis on Urine Output in Patients With Acute Renal Failure on CVVH
- ClinicalTrials.gov ID
- NCT00207909
- Acronym / sponsor ID
- 04-114
- Conditions
- Renal Failure
- Keywords
- Acute Renal Failure, Contiuous Veno Venous Hemofiltration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Children's Healthcare of AtlantaUniversity, hospital or other
- Study start
- Feb 2005
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 21 Sep 2005 (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.
Acute kidney failure is common in children in the Pediatric Intensive Care Unit (PICU). You are being asked to participate in this study because your child is being treated for kidney failure with continuous veno-venous hemofiltration (CVVH). CVVH is a continuous, gentle form of removing excess fluids and small wastes from the blood, similar to kidney dialysis (artificial kidney). It is an accepted therapy for temporary support of kidney failure. In some patients with acute kidney failure, beginning CVVH is followed by a temporary decrease of urine output. The reason why this happens is currently unknown. The purpose of this study is to determine why this happens.
Detailed description
Acute renal failure is common in children in the pediatric intensive care unit. Renal replacement therapies such as peritoneal dialysis (PD), intermittent hemodialysis (IHD), and continuous venovenous hemofiltration (CVVH) have been used in the management of acute renal failure. CVVH is becoming increasingly utilized in pediatric acute renal failure. However, in patients who have acute renal failure, the institution of CVVH is often followed by a progression to oliguria or anuria. The underlying pathophysiology of this change is unknown. We believe that this progression is influenced by changes in the renin-angiotensin axis, cytokine response, and other modifiers of renal hemodynamics. By serially measuring components of those systems, this study will attempt to elucidate the pathophysiology of the decreased urine output seen with institution of CVVH. Once this process is understood, future studies should focus on prevention and treatment of this complication.
General Hypothesis
The decrease in urine output seen after the initiation of CVVH is associated with increased angiotensin converting enzyme (ACE) levels, increased renin activity, increased angiotensin II levels, increased atrial naturetic peptide (ANP) levels, increased endothelin-1 levels, increased arginine vasopressin (AVP) levels, and alterations of cytokine levels and modulators of apoptosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients Pediatric Intensive Care Unit @ Egleston meeting inclusion criteria / avoiding exclusion criteria.
Key inclusion criteria (17 listed)
- The general goal of patient selection is to enroll all children for whom CVVH is instituted.
- Age
- 6 months -18 years old
- Patients less than 6 months of age on ECMO (addendum #1)
- Acute Renal Failure
Key exclusion criteria (8 listed)
- Age
- Inability or unwillingness of the legal guardian to provide consent or inability or unwillingness of the child to provide assent
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
To determine the underlying etiology of the decrease in urine output seen with the institution of CVVH by examining patient's physiologic hormonal responses.
Time frame: 12 months
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 14 Jun 2016.
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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.
James D Fortenberry, MD principal investigator
Children's Healthcare of Atlanta
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 Renal Failure, run by Children's Healthcare of Atlanta 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 17 inclusion and 8 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 14 Jun 2016. 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?
To determine the underlying etiology of the decrease in urine output seen with the institution of CVVH by examining patient's physiologic hormonal responses. (time frame: 12 months). 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 14 Jun 2016.