Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06344546
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-03
First Post:
2024-03-07
Brief Title:
Metabolic Pathway Analysis in Intensive Care Unit Patients With Refeeding Syndrome
Sponsor:
Karolinska University Hospital
Organization:
Karolinska University Hospital
Study Overview
Official Title:
Metabolic Pathway Analysis in Refeeding Syndrome a Nested Explorative Metabolomics Substudy of the GUTPHOS Multicenter Observational Study GUTPHOS-Metabolomics
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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 overall aim of the study is to improve understanding of refeeding syndrome RFS in patients admitted to the intensive care unit ICU using metabolomics Patients are included as part of a prospective multicenter observational study on phosphate disorders in the ICU Blood samples are collected day 1-7 of ICU stay Samples from patients who develop refeeding hypophosphatemia and matched controls without hypophosphatemia are analysed for metabolomics and proteomics Untargeted analyses will be performed to identify the affected metabolic pathways The investigators will also perform AUROC analyses to identify potential biomarkers for early detection of RFS
Detailed Description:
A nested case-control study situated within GUTPHOS Part B A prospective multicenter non-interventional cohort study investigating the incidence of abnormal phosphate levels and associated outcomes in adult patients admitted to the ICUs of participating sites Inclusionexclusion criteria for GUTPHOS Part B are described in the separate study protocol
At sites participating in the nested substudy an additional 2 ml EDTA blood sample is drawn once daily in all patients included in GUTPHOS Part B from ICU admission up to a maximum of calendar day 7 in ICU The sampling for metabolomics analysis should be performed in close proximity with daily routine blood tests and always before treatment of hypophosphatemia with phosphate supplementation or restricted nutritional intake Plasma samples are obtained through centrifugation within 20 minutes and frozen to -80 degrees Celcius within 60 minutes until analysis The timing and handling of samples according to standard operating procedures will be documented on a separate case report form
In ICU patients diagnosed with refeeding hypophosphatemia comprehensive metabolomic profiling is performed in the plasma sample from ICU admission and the sample drawn in conjunction to the blood phosphate measurement diagnostic of RH
Cases with RH are matched in a 11 ratio to ICU patients without RH Controls are matched according to sex age illness severity on admission and energy delivery kcalkg adjusted body weight in the 24 hours preceding the diagnosis of RH
Refeeding hypophosphatemia is defined as new onset hypophosphatemia 065 mmolL within 72 hours from the start of medical nutrition therapy with a drop of 016 mmolL from any previous Pi value during ICU stay and where no other likely cause of hypophosphatemia is present
At sites participating in the nested substudy an additional 2 ml EDTA blood sample is drawn once daily in all patients included in GUTPHOS Part B from ICU admission up to a maximum of calendar day 7 in ICU The sampling for metabolomics analysis should be performed in close proximity with daily routine blood tests and always before treatment of hypophosphatemia with phosphate supplementation or restricted nutritional intake Plasma samples are obtained through centrifugation within 20 minutes and frozen to -80 degrees Celcius within 60 minutes until analysis The timing and handling of samples according to standard operating procedures will be documented on a separate case report form
In ICU patients diagnosed with refeeding hypophosphatemia comprehensive metabolomic profiling is performed in the plasma sample from ICU admission and the sample drawn in conjunction to the blood phosphate measurement diagnostic of RH
Cases with RH are matched in a 11 ratio to ICU patients without RH Controls are matched according to sex age illness severity on admission and energy delivery kcalkg adjusted body weight in the 24 hours preceding the diagnosis of RH
Refeeding hypophosphatemia is defined as new onset hypophosphatemia 065 mmolL within 72 hours from the start of medical nutrition therapy with a drop of 016 mmolL from any previous Pi value during ICU stay and where no other likely cause of hypophosphatemia is present
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None