Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT02470520
Status:
COMPLETED
Last Update Posted:
2016-05-17
First Post:
2015-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Essential Nutrients in Critically Ill Patients With Severe AKI Treated With and Without CRRT
Sponsor:
Guy's and St Thomas' NHS Foundation Trust
Organization:
Study Overview
Official Title:
Observational Study Measuring Essential Nutrients in Critically Ill Patients With Severe Acute Kidney Injury Treated With and Without Continuous Haemofiltration
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: