Acute Renal FailurePhase 2NCT00179166
Assessment of Metabolic Response in Critically Ill Patients With Acute Renal Failure
A Phase 2 study testing TPN nutritional supplement in people with Acute Renal Failure, run by Vanderbilt University at 1 site in United States.
Trial summary
We hypothesize that a nutritional supplementation with higher than standard protein content (2.0 gm/Kg/day vs 1.4 gm/Kg/day) will result in improved whole-body net protein balance when administered to critically ill patients with acute renal failure (ARF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Renal Failure
- What is being tested?
- TPN nutritional supplement
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Jul 2005
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥ 18 years of age admitted to the intensive care unit
- New onset acute renal failure (ARF) or ARF superimposed on chronic kidney disease
- ARF will be defined by a sustained (over 24 hours) increase in serum creatinine > 0.5 mg/dl from baseline
- Patients will be recruited for the study within 3-5 days following establishment of ARF
Who cannot join
- Institutionalized patient
- Previous kidney transplant
- Pregnancy
- Unable to obtain consent from subject or legally recognized representative
- ARF from urinary tract obstruction or a volume responsive pre-renal state.
- Liver Failure
Show all 9Show fewer
- Recent cerebrovascular accident (CVA)
- Coagulopathy defined as: Platelets < 50, PT > 20, INR > 2.0 if the patient requires the placement of an arterial or venous catheter; if the patient does not require the placement of an arterial or venous catheter for the study, coagulopathy will not be a basis for exclusion.
- Life expectancy < 48 hours
Trial locations and contacts
1 site in 1 country.
About this study
We hypothesize that a nutritional supplementation with higher than standard protein content (2.0 gm/Kg/day vs 1.4 gm/Kg/day) will result in improved whole-body net protein balance when administered to critically ill patients with acute renal failure (ARF).
- Conditions
- Acute Renal Failure
- Being tested
- TPN nutritional supplement
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPN nutritional supplementDrug
intravenous administration of nutritional supplement for 4 hours at a dosage of 30 kcal/kg/day, in the form of lipids, carbohydrates and protein; the non-protein calories are comprised of lipids (30%) and carbohydrates (70%)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | supplement contains protein content of 1.4 g/kg/day Receives: Drug: TPN nutritional supplement |
| 2 | Active comparator | supplement contains protein content of 2.0 g/kg/day Receives: Drug: TPN nutritional supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
whole-body net protein balance
Measured: 10 hours
Secondary outcomes (1)
Net skeletal muscle protein balance
Measured: 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJun 2004
- Primary completionJul 2005
- Study completionJul 2005
Why it stopped: lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Investigators
- Alp Ikizler, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00179166
- Sponsor's protocol ID
- 30941
- Status last verified
- Sep 2010
- First submitted
- 13 Sep 2005
- Last updated
- 27 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Metabolic Response in Critically Ill Patients With Acute Renal Failure
- ClinicalTrials.gov ID
- NCT00179166
- Acronym / sponsor ID
- 30941
- Conditions
- Acute Renal Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of enrollment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Jun 2004
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 15 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.
We hypothesize that a nutritional supplementation with higher than standard protein content (2.0 gm/Kg/day vs 1.4 gm/Kg/day) will result in improved whole-body net protein balance when administered to critically ill patients with acute renal failure (ARF).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: TPN nutritional supplementsupplement contains protein content of 1.4 g/kg/day |
| 2 | Active comparator | Drug: TPN nutritional supplementsupplement contains protein content of 2.0 g/kg/day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults ≥ 18 years of age admitted to the intensive care unit
- New onset acute renal failure (ARF) or ARF superimposed on chronic kidney disease
- ARF will be defined by a sustained (over 24 hours) increase in serum creatinine > 0.5 mg/dl from baseline
- Patients will be recruited for the study within 3-5 days following establishment of ARF
Key exclusion criteria (9 listed)
- Institutionalized patient
- Previous kidney transplant
- Pregnancy
- Unable to obtain consent from subject or legally recognized representative
- ARF from urinary tract obstruction or a volume responsive pre-renal state.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TPN nutritional supplementintravenous administration of nutritional supplement for 4 hours at a dosage of 30 kcal/kg/day, in the form of lipids, carbohydrates and protein; the non-protein calories are comprised of lipids (30%) and carbohydrates (70%) | Drug | 1, 2 |
Primary outcome
whole-body net protein balance
Time frame: 10 hours
1 secondary outcome
Net skeletal muscle protein balance
Time frame: 10 hours
Results and safety
The study was stopped early (reason given: lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2010.
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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.
Alp Ikizler, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TPN nutritional supplement in people with Acute Renal Failure, run by Vanderbilt University 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 4 inclusion and 9 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: stopped early, as of the sponsor's last update on 27 Sep 2010. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: lack of enrollment). Results are not available in the source record.
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?
whole-body net protein balance (time frame: 10 hours). 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 27 Sep 2010.