Effect of continuous haemofiltration on essential micronutrient levels

ISRCTN	ISRCTN88354940
DOI	https://doi.org/10.1186/ISRCTN88354940
Secondary identifying numbers	1

Submission date: 25/11/2012
Registration date: 10/06/2013
Last edited: 06/08/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr Marlies Ostermann
Scientific

King's College London
Guy's & St Thomas Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom

Phone	+44 20 7188 1544
Email	Marlies.Ostermann@gstt.nhs.uk

Study information

Study design	Prospective observational cohort study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Effect of continuous haemofiltration on essential nutrients in critically ill patients with severe acute kidney injury
Study objectives	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(s)	National Research Ethics Committee on the 11/03/2013, ref: 13/LO/0064
Health condition(s) or problem(s) studied	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
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 study start date	01/01/2013
Completion date	31/12/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	40
Key inclusion criteria	Adult patients (18 years or older) in the intensive care unit with severe AKI
Key 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
Date of first enrolment	01/01/2013
Date of final enrolment	31/12/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

King's College London

London
SE1 7EH
United Kingdom

Sponsor information

Guy's & St Thomas Hospital (UK)
Hospital/treatment centre

c/o Mrs Karen Ignatian
Research & Development Department
Great Maze Road
London
SE1 9RT
England
United Kingdom

Phone	+44 20 7188 5736
Email	Karen.Ignatian@gstt.nhs.uk
Website	http://www.guysandstthomas.nhs.uk
"ROR"	https://ror.org/00j161312

Funders

Funder type

Research organisation

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	02/08/2018		Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

06/08/2018: Publication reference added.
07/07/2016: No publications found, verifying study status with principal investigator.