Acute Kidney FailureNCT02470520
Essential Nutrients in Critically Ill Patients With Severe AKI Treated With and Without CRRT
An observational study of Acute Kidney Failure, run by Guy's and St Thomas' NHS Foundation Trust.
Trial summary
The aim of this study is to measure plasma levels of essential vitamins, trace elements and amino acids in critically ill patients with severe AKI. In patients who are treated with continuous renal replacement therapy, we plan to evaluate whether there are any additional losses of nutrients into the filtrate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Failure
- What is being tested?
- CRRT
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Aug 2013to Nov 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients with severe acute kidney injury
Who may be able to join
- adult patients in the Critical Care Unit with severe AKI
Who cannot join
- pre-existing dialysis dependent renal failure
- life expectancy <48 hours
- need for total parenteral nutrition
- need for supplementation with intravenous multivitamins or trace elements
- Jehovah's witness
- patients with haemoglobin <7g/dL (unless being transfused for clinical reasons)
About this study
Official title: Observational Study Measuring Essential Nutrients in Critically Ill Patients With Severe Acute Kidney Injury Treated With and Without Continuous Haemofiltration
The aim of this study is to measure plasma levels of essential vitamins, trace elements and amino acids in critically ill patients with severe AKI. In patients who are treated with continuous renal replacement therapy, we plan to evaluate whether there are any additional losses of nutrients into the filtrate.
Read the detailed description
Background: Critically ill patients with acute kidney injury (AKI) have a high risk of dying, especially if renal replacement therapy (RRT) is needed. It remains uncertain whether essential trace elements, vitamins and amino acids are lost during RRT in sufficient amounts to result in clinically significant deficiencies. At present, nutrition guidelines for patients with AKI on RRT do not account for any potential losses of micronutrients across the filter.
Hypothesis:
Critically ill patients with AKI have inadequate plasma nutrient levels. If continuous renal replacement therapy (CRRT) is required, there are additional losses of essential nutrients.
Aims:
To serially measure plasma levels of essential vitamins, trace elements and amino acids in critically ill patients with severe AKI and to evaluate whether there are any additional losses into the filtrate during CRRT
Objectives:
To perform serial measurements of plasma levels of selenium, zinc, copper, iron, vitamins B1, B6, B12, C and D, folic acid and essential amino acids in all patients with severe AKI and to measure any losses of the same nutrients in the filtrate in a cohort of patients on CRRT for >24 hours.
Patient population:
level 3 critically ill adult patients with severe AKI
Study size:
40 patients of whom 20 patients are treated with CRRT for >24 hours.
Study design:
observational non-interventional study in at least 2 large tertiary care centres in the United Kingdom
Outcomes:
Primary outcome: difference in plasma concentrations of essential trace elements and vitamins between patients with and without CRRT.
Secondary outcomes: a) concentrations of trace elements, vitamins and amino acids in filtrate in patients on CRRT; b) differences in filtrate losses between patients on CRRT ≤30ml/kg/hr versus >30ml/kg/hr.
Laboratory measurements:
Measurement of baseline plasma Selenium, Zinc, Copper, iron, Vitamins B1, B6, B12, C and D, folic acid and essential amino acids levels and repeat serial measurement of the same panel of nutrients in all patients for up to 6 days with additional concomitant measurement of nutrient levels in filtrate in cohort of patients on CRRT. In addition, daily measurement of serum electrolytes, liver profile, serum albumin and c-reactive protein.
Data collection:
Recording of the following potential confounders: type of nutrition, dose of CRRT, type of membrane.
Statistics:
Determination of the change in plasma nutrient levels over 6 days, and between baseline and 24 - 144 hours after initiation of CRRT. The estimates will be used to inform the design of an intervention study exploring the value of nutrient supplementation.
- Conditions
- Acute Kidney Failure
- Being tested
- CRRT
- 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.
CRRTProcedure or surgery
continuous renal replacement therapy
| Study group | Role | What they receive |
|---|---|---|
| AKI without CRRT | Patients with AKI who are not treated with continuous renal replacement therapy | |
| AKI with CRRT | Patients with AKI who are treated with continuous renal replacement therapy Receives: Procedure: CRRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum levels of essential nutrients
Measured: up to 6 days
Secondary outcomes (1)
levels of essential nutrients in filtrate
concentrations of trace elements, vitamins and amino acids in filtrate in patients on CRRT
Measured: up to 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2015 (estimated)
- Study startAug 2013
- Primary completionNov 2014
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney FailureStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02470520
- Sponsor's protocol ID
- RJ113/N062
- Status last verified
- May 2016
- First submitted
- 10 Jun 2015
- Last updated
- 17 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study Measuring Essential Nutrients in Critically Ill Patients With Severe Acute Kidney Injury Treated With and Without Continuous Haemofiltration
- ClinicalTrials.gov ID
- NCT02470520
- Acronym / sponsor ID
- RJ113/N062
- Conditions
- Acute Kidney Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 12 Jun 2015 (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 aim of this study is to measure plasma levels of essential vitamins, trace elements and amino acids in critically ill patients with severe AKI. In patients who are treated with continuous renal replacement therapy, we plan to evaluate whether there are any additional losses of nutrients into the filtrate.
Detailed description
Background: Critically ill patients with acute kidney injury (AKI) have a high risk of dying, especially if renal replacement therapy (RRT) is needed. It remains uncertain whether essential trace elements, vitamins and amino acids are lost during RRT in sufficient amounts to result in clinically significant deficiencies. At present, nutrition guidelines for patients with AKI on RRT do not account for any potential losses of micronutrients across the filter.
Hypothesis:
Critically ill patients with AKI have inadequate plasma nutrient levels. If continuous renal replacement therapy (CRRT) is required, there are additional losses of essential nutrients.
Aims:
To serially measure plasma levels of essential vitamins, trace elements and amino acids in critically ill patients with severe AKI and to evaluate whether there are any additional losses into the filtrate during CRRT
Objectives:
To perform serial measurements of plasma levels of selenium, zinc, copper, iron, vitamins B1, B6, B12, C and D, folic acid and essential amino acids in all patients with severe AKI and to measure any losses of the same nutrients in the filtrate in a cohort of patients on CRRT for >24 hours.
Patient population:
level 3 critically ill adult patients with severe AKI
Study size:
40 patients of whom 20 patients are treated with CRRT for >24 hours.
Study design:
observational non-interventional study in at least 2 large tertiary care centres in the United Kingdom
Outcomes:
Primary outcome: difference in plasma concentrations of essential trace elements and vitamins between patients with and without CRRT.
Secondary outcomes: a) concentrations of trace elements, vitamins and amino acids in filtrate in patients on CRRT; b) differences in filtrate losses between patients on CRRT ≤30ml/kg/hr versus >30ml/kg/hr.
Laboratory measurements:
Measurement of baseline plasma Selenium, Zinc, Copper, iron, Vitamins B1, B6, B12, C and D, folic acid and essential amino acids levels and repeat serial measurement of the same panel of nutrients in all patients for up to 6 days with additional concomitant measurement of nutrient levels in filtrate in cohort of patients on CRRT. In addition, daily measurement of serum electrolytes, liver profile, serum albumin and c-reactive protein.
Data collection:
Recording of the following potential confounders: type of nutrition, dose of CRRT, type of membrane.
Statistics:
Determination of the change in plasma nutrient levels over 6 days, and between baseline and 24 - 144 hours after initiation of CRRT. The estimates will be used to inform the design of an intervention study exploring the value of nutrient supplementation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AKI without CRRT | – | –Patients with AKI who are not treated with continuous renal replacement therapy |
| AKI with CRRT | – | Procedure: CRRTPatients with AKI who are treated with continuous renal replacement therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients with severe acute kidney injury
Key inclusion criteria (1 listed)
- adult patients in the Critical Care Unit with severe AKI
Key exclusion criteria (6 listed)
- pre-existing dialysis dependent renal failure
- life expectancy <48 hours
- need for total parenteral nutrition
- need for supplementation with intravenous multivitamins or trace elements
- Jehovah's witness
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 |
|---|---|---|
| CRRTcontinuous renal replacement therapy | Procedure or surgery | AKI with CRRT |
Primary outcome
serum levels of essential nutrients
Time frame: up to 6 days
1 secondary outcome
levels of essential nutrients in filtrate
Time frame: up to 6 days
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 17 May 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Failure, run by Guy's and St Thomas' NHS Foundation Trust.
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 6 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 17 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
serum levels of essential nutrients (time frame: up to 6 days). 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 17 May 2016.