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Essential Nutrients in Critically Ill Patients With Severe AKI Treated With and Without CRRT

Observational Study Measuring Essential Nutrients in Critically Ill Patients With Severe Acute Kidney Injury Treated With and Without Continuous Haemofiltration

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02470520
Enrollment
40
Registered
2015-06-12
Start date
2013-08-31
Completion date
2015-11-30
Last updated
2016-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Failure

Brief summary

The aim of this study is to measure plasma levels of essential vitamins, trace elements and amino acids in critically ill patients with severe AKI. In patients who are treated with continuous renal replacement therapy, we plan to evaluate whether there are any additional losses of nutrients into the filtrate.

Detailed description

Background: Critically ill patients with acute kidney injury (AKI) have a high risk of dying, especially if renal replacement therapy (RRT) is needed. It remains uncertain whether essential trace elements, vitamins and amino acids are lost during RRT in sufficient amounts to result in clinically significant deficiencies. At present, nutrition guidelines for patients with AKI on RRT do not account for any potential losses of micronutrients across the filter. Hypothesis: Critically ill patients with AKI have inadequate plasma nutrient levels. If continuous renal replacement therapy (CRRT) is required, there are additional losses of essential nutrients. Aims: To serially measure plasma levels of essential vitamins, trace elements and amino acids in critically ill patients with severe AKI and to evaluate whether there are any additional losses into the filtrate during CRRT Objectives: To perform serial measurements of plasma levels of selenium, zinc, copper, iron, vitamins B1, B6, B12, C and D, folic acid and essential amino acids in all patients with severe AKI and to measure any losses of the same nutrients in the filtrate in a cohort of patients on CRRT for \>24 hours. Patient population: level 3 critically ill adult patients with severe AKI Study size: 40 patients of whom 20 patients are treated with CRRT for \>24 hours. Study design: observational non-interventional study in at least 2 large tertiary care centres in the United Kingdom Outcomes: Primary outcome: difference in plasma concentrations of essential trace elements and vitamins between patients with and without CRRT. Secondary outcomes: a) concentrations of trace elements, vitamins and amino acids in filtrate in patients on CRRT; b) differences in filtrate losses between patients on CRRT ≤30ml/kg/hr versus \>30ml/kg/hr. Laboratory measurements: Measurement of baseline plasma Selenium, Zinc, Copper, iron, Vitamins B1, B6, B12, C and D, folic acid and essential amino acids levels and repeat serial measurement of the same panel of nutrients in all patients for up to 6 days with additional concomitant measurement of nutrient levels in filtrate in cohort of patients on CRRT. In addition, daily measurement of serum electrolytes, liver profile, serum albumin and c-reactive protein. Data collection: Recording of the following potential confounders: type of nutrition, dose of CRRT, type of membrane. Statistics: Determination of the change in plasma nutrient levels over 6 days, and between baseline and 24 - 144 hours after initiation of CRRT. The estimates will be used to inform the design of an intervention study exploring the value of nutrient supplementation.

Interventions

PROCEDURECRRT

continuous renal replacement therapy

Sponsors

Guy's and St Thomas' NHS Foundation Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* adult patients in the Critical Care Unit with severe AKI

Exclusion criteria

* pre-existing dialysis dependent renal failure * life expectancy \<48 hours * need for total parenteral nutrition * need for supplementation with intravenous multivitamins or trace elements * Jehovah's witness * patients with haemoglobin \<7g/dL (unless being transfused for clinical reasons)

Design outcomes

Primary

MeasureTime frame
serum levels of essential nutrientsup to 6 days

Secondary

MeasureTime frameDescription
levels of essential nutrients in filtrateup to 6 daysconcentrations of trace elements, vitamins and amino acids in filtrate in patients on CRRT

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026