Status:
UNKNOWN
A Study to Investigate the Effect of HMB on Skeletal Muscle Wasting in Early Critical Illness
Lead Sponsor:
Guy's and St Thomas' NHS Foundation Trust
Conditions:
Critical Illness
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief Summary
This study aims to investigate the effect of beta-hydroxy-beta-methylbutyrate (HMB) on skeletal muscle wasting, physical function, strength and quality of life in survivors of critical illness. In add...
Detailed Description
This is a double blind, placebo controlled, randomised controlled trial with the primary objective of investigating the effect of HMB on skeletal muscle wasting in early critical illness. Secondary ob...
Eligibility Criteria
Inclusion
- (i) ≥18 years old (ii) Due to receive enteral nutrition via a nasogastric or naso-jejunal tube as part of routine care (iii) Receiving mechanical ventilation and likely to continue this for more than 48 hours (iv) Likely to remain on the ICU for \>7 days (v) Likely to survive intensive care admission. (vi) Admitted to recruiting ICU \<24 hours from hospital admission and referring ICU ≥7 days from hospital admission (vii) Agreement obtained from legal representative (viii) Able to comply with protocol and study procedures (ix) No known allergy to IMP or any of its excipients
- Participants in other trials can be recruited where protocols are not deemed likely to interfere with endpoints of either study and agreement has been obtained from the respective Chief Investigators.
- Since participants in the trial will be abstaining by virtue of their illness, contraception is not required as an eligibility requirement.
Exclusion
- (i) Pregnancy or breast feeding (ii) Active disseminated malignancy (diagnosed) (iii) Bilateral lower limb amputees (iv) Non-ambulant or acute unilateral lower limb amputees (v) Patients with a primary neuromyopathy (vi) Patients entered into trials of interventions which would affect muscle mass (vii) Patients assessed as requiring sole parenteral nutrition (viii) Admission to ICU within the previous 3 months (ix) Any reason excluding ultrasound measurement being performed (x) Insufficient understanding of the trial by the legal representative (xi) Intolerance to lactose and/or milk protein allergy
Key Trial Info
Start Date :
June 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2021
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT03464708
Start Date
June 18 2018
End Date
August 1 2021
Last Update
March 17 2021
Active Locations (1)
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1
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom, SE1 7EH