Plain English Summary
Background and study aims
Seriously ill patients, with acute kidney injury (AKI), have high risk of death, especially if procedures like dialysis or haemofiltration are necessary to clear waste products. Previous studies suggest that these procedures lead to loss of nutrients from the body. It is unclear whether these losses are important and lead to nutrient deficiency. Official nutrition guidelines for patients with AKI are contradicting and don't recommend routine nutrient supplementation. It is possible that these losses are underestimated and that they may contribute to diseases and death, particularly in patients who need frequent haemofiltration for a long time. Our aim is to regularly measure vitamins, proteins and essential nutrients in critically ill patients with AKI. We hope to find out whether patients, who need regular haemofiltration, lose nutrients and whether these losses lower their levels in the blood. If our study shows that patients with AKI indeed have signs of nutrient deficiency, we will plan a future study to explore whether it is beneficial to give patients nutrient supplements routinely and whether this reduces the risk of death.
Who can participate?
Critically ill adult patients (≥ 18 years) with severe AKI can participate in this study.
What does the study involve?
Several blood tests are taken to measure essential nutrients in the blood, for over a period of 6 days. The patients are followed until discharge from the hospital.
What are the possible benefits and risks of participating?
There are no immediate benefits to the patients who are taking part. There are no risks and participating in this study does not affect the chances of making a good recovery. The patients do not receive any treatment, nutrition or drugs different from what they would receive if they did not participate in the study.
Where is the study run from?
The study is coordinated by a team at Guy's & St Thomas Hospital, London, UK.
When is the study starting and how long is it expected to run for?
The study started in early 2013 and is expected to last for 4-6 months.
Who is funding the study?
The study is funded by a research award from the European Society of Intensive Care Medicine, Belgium.
Who is the main contact?
Dr M Ostermann
Marlies.Ostermann@gstt.nhs.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Marlies Ostermann
ORCID ID
Contact details
King's College London
Guy's & St Thomas Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom
+44 20 7188 1544
Marlies.Ostermann@gstt.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1
Study information
Scientific title
Effect of continuous haemofiltration on essential nutrients in critically ill patients with severe acute kidney injury
Acronym
Study hypothesis
In patients with severe acute kidney injury (AKI) treated with continuous veno-venous haemofiltration, vitamins, trace elements and essential amino acids are lost into the filtrate and lead to nutrient deficiency.
Ethics approval
National Research Ethics Committee on the 11/03/2013, ref: 13/LO/0064
Study design
Prospective observational cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Acute kidney injury
Intervention
The following parameters will be measured:
1. Plasma levels of selenium, zinc, copper, iron, vitamins B1, B6, B12, C and D, folic acid, essential amino acids at baseline and alternate days for 6 days
2. In patients on haemofiltration: levels of selenium, zinc, copper, iron, vitamins B1, B6, B12, C and D, folic acid, essential amino acids in filtrate fluid
3. Daily measurement of serum electrolytes, liver profile, serum albumin and C-reactive protein
4. Recording of severity of illness scores and outcome (duration of stay in ICU, ICU mortality, hospital outcome)
Total duration of follow-up: until discharge from hospital or death (whichever occurs first)
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Outcomes will be assessed on a daily basis for up to 6 days after enrolment.
Dfference in plasma concentrations of essential micronutrients between patients with and without continuous veno-venous haemofiltration (CVVH)
Secondary outcome measures
1. Concentrations of trace elements, vitamins and amino acids in filtrate in patients on CVVH
2. Differences in filtrate losses between patients on continuous venovenous hemofiltration (CVVH) 30ml/kg/hr or less versus >30ml/kg/hr
3. Differences in serum levels of micronutrients and amino acids between patients on CVVH 30ml/kg/hr or less versus >30ml/kg/hr
Overall trial start date
01/01/2013
Overall trial end date
31/12/2013
Reason abandoned
Eligibility
Participant inclusion criteria
Adult patients (18 years or older) in the intensive care unit with severe AKI
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant exclusion criteria
1. Pre-existing dialysis dependent renal failure
2. Life expectancy <48 hours
3. Need for total parenteral nutrition
4. Need for supplementation with intravenous multivitamins or trace elements
Recruitment start date
01/01/2013
Recruitment end date
31/12/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
King's College London
London
SE1 7EH
United Kingdom
Sponsor information
Organisation
Guy's & St Thomas Hospital (UK)
Sponsor details
c/o Mrs Karen Ignatian
Research & Development Department
Great Maze Road
London
SE1 9RT
United Kingdom
+44 20 7188 5736
Karen.Ignatian@gstt.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
European Society of Intensive Care Medicine (Belgium) - Research Award
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary