Skip to content

Inflammatory and nutritional changes during critical illness

An investigation into inflammatory and nutritional markers during critical illness to identify an indicator of anabolism and to explore a method of attenuating muscle mass loss

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN79066838
Enrollment
120
Registered
2012-07-30
Start date
2010-09-30
Completion date
Unknown
Last updated
2019-12-10

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

Conditions

Critical care Not Applicable

Interventions

Intervention group: Essential Amino Acid supplementation given twice daily in addition to standard enteral feed. Control group: Usual care - Standard enteral feed given according to ne

Sponsors

Imperial College London (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Part 1: Intensive Care Unit (ICU): Patients mechanically ventilated for > 48h High Dependency Unit (HDU): 1. Trauma patients > 18 years. 2. Patients should be entered into the trial within 72h of ICU admission. Part 2: 1. Trauma patients (head and multiple trauma) admitted to Intensive Care expected to be ventilated for > 48h 2. Over 18 years of age 3. Patients should be entered into the trial within 72 hours of ICU admission 4. Male and female participants 5. Between 18 - 95 years

Exclusion criteria

Exclusion criteria: Part 1: Patients expected to be ventilated for < 48h; Non-trauma HDU patients. Part 2: 1. Medical ICU patients 2. Surgical (non-trauma) ICU patients 3. Patients enrolled in another interventional clinical trial 4. Patients where enteral feeding is contraindicated 5. Cardiac failure 6. End Stage Renal Failure 7. Chronic Obstructive Pulmonary Disease 8. Chronic liver disease (cirrhosis)

Design outcomes

Primary

MeasureTime frame
Muscle change with a muscle ultrasound technique measured daily for 1st week, twice weekly after

Secondary

MeasureTime frame
Functional outcomes: 1. Katz & Barthel indexes measured at day 1, 7, 14, 20 2. Indirect calorimetry measured at day 1, 5, 7, 14 3. Inflammatory markers: CRP, Albumin, cytokines measured at day 1, 5, 7, 14 4. Plasma amino acids measured at day 1, 10 5. Protein turnover with stable isotopes measured at day 1, 10, 20 6. Urinary amino acids measured at day 1, 5, 7, 14

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 2, 2026