Ignite Creation Date:
2024-05-06 @ 4:09 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04896515
Status:
COMPLETED
Last Update Posted:
2024-05-24
First Post:
2021-04-15
Brief Title:
INTENT-Muscle A Sub-study of INTENT
Sponsor:
Australian and New Zealand Intensive Care Research Centre
Organization:
Australian and New Zealand Intensive Care Research Centre
Study Overview
Official Title:
Intensive Nutrition Therapy Compared to Usual Care in Critically Ill Adults A Randomised Pilot Trial - Muscle a Sub-study of INTENT
Status:
COMPLETED
Status Verified Date:
2024-05
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 currently recruiting randomised controlled trial Intensive Nutrition Therapy Compared to Usual Care in Critically Ill Adults INTENT NCT03292237 is the first multi-centre trial to compare an intensive individualised nutrition intervention to standard care for the duration of hospital admission in critically ill patients INTENT-Muscle is an observational longitudinal study nested within INTENT The aim of INTENT-Muscle is to compare longitudinal changes in muscle health assessed by bioimpedance and muscle ultrasound in critically ill patients randomised to each arm of INTENT
Detailed Description:
Background Critically ill patients may experience debilitating loss of muscle mass and strength leading to substantial functional impairments both during and long after hospitalisation Little is known about what therapies may attenuate deterioration of muscle health muscle mass and muscle quality in this setting but nutrition is thought to be important based on the physiological response to critical illness
The currently recruiting randomised controlled trial RCT Intensive Nutrition Therapy Compared to Usual Care in Critically Ill Adults ClinicalTrialsgov Identifier NCT03292237 is the first multi-centre trial to provide an individualised nutrition intervention for the duration of hospital admission in critically ill patients Combining the most promising and novel bedside techniques for objectively measuring muscle health bioimpedance technology and ultrasound with a whole hospital nutrition intervention has never been done before and will provide crucial data to understand the relationship between nutrition delivery and changes in muscularity from ICU admission to hospital discharge
Aim To explore changes in muscle health in response to an individualised nutrition intervention and in association with clinical and functional outcomes using clinically applicable bedside techniques
Secondary aims
In both arms of INTENT to
1 Compare longitudinal changes in bioimpedance variables fat-free mass normally hydrated lean tissue extracellularintracellular ratio and variables from Cole modelling to hospital discharge or day 28
2 Compare longitudinal changes in ultrasound variables mid-upper arm and quadriceps muscle thickness rectus femoris cross-sectional area and rectus femoris echogenicity to hospital discharge or day 28
3 Compare clinical and functional outcomes in patients identified as having low muscularity assessed by ultrasound at ICU admission
4 Investigate the relationship between bioimpedance and ultrasound variables with clinical and functional outcomes at baseline and over the hospital admission collected as part of INTENT
Hypothesis In critically ill patients receiving individualised nutrition care for the duration of hospital admission censored at study day 28 declines in phase angle and muscle health will be attenuated compared to patients receiving standard nutritional care
The currently recruiting randomised controlled trial RCT Intensive Nutrition Therapy Compared to Usual Care in Critically Ill Adults ClinicalTrialsgov Identifier NCT03292237 is the first multi-centre trial to provide an individualised nutrition intervention for the duration of hospital admission in critically ill patients Combining the most promising and novel bedside techniques for objectively measuring muscle health bioimpedance technology and ultrasound with a whole hospital nutrition intervention has never been done before and will provide crucial data to understand the relationship between nutrition delivery and changes in muscularity from ICU admission to hospital discharge
Aim To explore changes in muscle health in response to an individualised nutrition intervention and in association with clinical and functional outcomes using clinically applicable bedside techniques
Secondary aims
In both arms of INTENT to
1 Compare longitudinal changes in bioimpedance variables fat-free mass normally hydrated lean tissue extracellularintracellular ratio and variables from Cole modelling to hospital discharge or day 28
2 Compare longitudinal changes in ultrasound variables mid-upper arm and quadriceps muscle thickness rectus femoris cross-sectional area and rectus femoris echogenicity to hospital discharge or day 28
3 Compare clinical and functional outcomes in patients identified as having low muscularity assessed by ultrasound at ICU admission
4 Investigate the relationship between bioimpedance and ultrasound variables with clinical and functional outcomes at baseline and over the hospital admission collected as part of INTENT
Hypothesis In critically ill patients receiving individualised nutrition care for the duration of hospital admission censored at study day 28 declines in phase angle and muscle health will be attenuated compared to patients receiving standard nutritional care
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