Is it feasible to apply a treatment called repetitive occlusive stimulus to reduce muscle wasting in critically ill patients?

Not Applicable

Completed

• Conditions: Specialty: Critical care, Primary sub-specialty: Critical Care; UKCRC code/ Disease: Generic Health Relevance/ No specific disease; Musculoskeletal Diseases; Muscle wasting

• Registration Number: ISRCTN44340629
• Lead Sponsor: Royal Surrey County Hospital NHS Foundation Trust

Brief Summary

2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/31340849 protocol (added 26/07/2019) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35887701/ (added 21/11/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-26
• Study Completion: 2019-07-31
• Last Update Posted: 4 December 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. Age = 18 years, both male & female
2. Admitted to the ICU within the past 36 hours
3. Personal consultee provides declaration of agreement for patient enrolment, retrospective patient consent
4. Invasive mechanical ventilation
5. At least 2 other organ failures as defined by scoring =1 points on two of the SOFA score domains
6. Likely to remain on ICU for at least 4 days as classified by attending consultant

Exclusion Criteria

1. Profound cardiovascular instability – infused vasopressors > = 0.5mcg/kg/min of norepinephrine; or in opinion of senior attending doctor
2. Profound coagulopathy (Prothrombin time> 2.5x normal or platelet count of < 80) or bleeding diathesis
3. Neuromuscular condition – any previous or concurrent neurological condition or muscle disease
4. History of peripheral arterial vascular disease – any previous surgery or interventional procedure for peripheral arterial insufficiency, or any reason to clinically suspect arterial insufficiency of the leg – such as collateral history of claudication or examination findings of absent peripheral pulses
5. Prior amputation of a lower limb
6. Obesity (BMI> 40); due to technical considerations.
7. Unlikely to survive ICU
8. Disseminated malignancy
9. Pregnancy
10. Previous, or current, DVT and PE
11. Positioned prone
12. Contraindication to pharmacological venous thromboembolism prophylaxis
13. Pre-existing significant cognitive impairment
14. Enrolled in a conflicting interventional trial
15. Lack ability to communicate in verbal and written English

Study & Design

• Study Type: Interventional
• Study Design: Not specified