Effect of continuous haemofiltration on essential micronutrient levels
| ISRCTN | ISRCTN88354940 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88354940 |
| Protocol serial number | 1 |
| Sponsor | Guy's & St Thomas Hospital (UK) |
| Funder | European Society of Intensive Care Medicine (Belgium) - Research Award |
- 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
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
Scientific
King's College London
Guy's & St Thomas Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom
| Phone | +44 20 7188 1544 |
|---|---|
| Marlies.Ostermann@gstt.nhs.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Prospective observational cohort study |
| Secondary study design | Cohort study |
| Study type | Participant 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(s) |
Outcomes will be assessed on a daily basis for up to 6 days after enrolment. |
| Key secondary outcome measure(s) |
1. Concentrations of trace elements, vitamins and amino acids in filtrate in patients on CVVH |
| Completion date | 31/12/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
SE1 7EH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
06/08/2018: Publication reference added.
07/07/2016: No publications found, verifying study status with principal investigator.
