Condition category
Urological and Genital Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

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

Trial website

Contact information



Primary contact

Dr Marlies Ostermann


Contact details

King's College London
Guy's & St Thomas Hospital
Westminster Bridge Road
United Kingdom
+44 20 7188 1544

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Effect of continuous haemofiltration on essential nutrients in critically ill patients with severe acute kidney injury


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


Secondary study design

Cohort study

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Acute kidney injury


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



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


Overall trial end date


Reason abandoned


Participant inclusion criteria

Adult patients (18 years or older) in the intensive care unit with severe AKI

Participant type


Age group




Target number of participants


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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

King's College London
United Kingdom

Sponsor information


Guy's & St Thomas Hospital (UK)

Sponsor details

c/o Mrs Karen Ignatian
Research & Development Department
Great Maze Road
United Kingdom
+44 20 7188 5736

Sponsor type

Hospital/treatment centre



Funder type

Research organisation

Funder name

European Society of Intensive Care Medicine (Belgium) - Research Award

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Publication citations

Additional files

Editorial Notes

07/07/2016: No publications found, verifying study status with principal investigator.