ISRCTN - ISRCTN88354940: Effect of continuous haemofiltration on essential micronutrient levels

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 measure

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 (if study stopped)

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 type

Hospital/treatment centre

Website

http://www.guysandstthomas.nhs.uk

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