|- candidate number||28524|
|- NTR Number||NTR7010|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||2-feb-2018|
|- Secondary IDs||METC Twente P18-01 NL64051.044.17|
|- Public Title||Effect of early mobilisation combined with additional protein on muscle mass in critically ill patients |
|- Scientific Title||Effect of early mobilisation combined with additional protein on muscle mass in critically ill patients |
|- hypothesis||We hypothesize that early mobilisation followed by additional protein intake is more effective in preservation of muscle mass than early mobilisation and optimal nutrition separately.|
|- Healt Condition(s) or Problem(s) studied||Muscle mass, Intensive care|
|- Inclusion criteria||- Included and randomized in the study within 48 hours after ICU admission. |
- Expected to stay on the ICU for at least 72 hours.
- Complete enteral nutrition. Or enteral nutrition in combination with parenteral or oral nutrition.
|- Exclusion criteria||-Complete parenteral feeding -> administration of ProSource not possible|
-Chronic renal failure or hepatic encephalopathy -> absolute contraindications of supplemental protein
-Acute kidney injury without CVVH or IHD -> relative contra-indication.22
-Poor prognosis (Anticipated mortality within 72 hours)
-Progressive neuro-muscular disease or neurotrauma
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mrt-2018|
|- planned closingdate||1-mrt-2019|
|- Target number of participants||40|
|- Interventions||Intervention group: Optimal feeding (proteins 1.5 g/kg), early mobilization (3 times a day), directly after mobilization additional 15 grams of proteins. Control group: Optimal feeding (proteins 1.5 g/kg) and early mobilization (3 times a day).|
|- Primary outcome||Muscle thickness of the mid-upper arm, forearm and thigh measured by ultrasonography|
|- Secondary outcome||• muscle quality (echogenicity determined with ultrasonography);|
• nutritional state and hydration status (Biva measurement);
• muscle force (MRC-sum and handgrip force);
• functional status (DEMMI);
• quality of life (EQ-5D);
|- Timepoints||Day 5, 10 and 14, at ICU discharge, at hospital discharge, and after 3 months follow-up |
|- Trial web site||none|
|- CONTACT FOR PUBLIC QUERIES|| Marieke Kloosterman|
|- CONTACT for SCIENTIFIC QUERIES|| Marieke Kloosterman|
|- Sponsor/Initiator ||Medisch Spectrum Twente|
(Source(s) of Monetary or Material Support)
|- Brief summary||Rationale: Muscle atrophy occurs often on the Intensive Care Unit (ICU) and has a negative impact on mortality, weaning from mechanical ventilation, the amount of days at the ICU and physical functioning after hospitalisation. Both early mobilisation as well as optimal nutritional support are important to reduce the amount of muscle loss. We hypothesize that early mobilisation followed by additional protein intake is more effective in preservation of muscle mass than early mobilisation and optimal nutrition separately.|
Objective: Is additional protein delivery directly after mobilization effective in delaying muscle atrophy (measured by muscle thickness determined with ultrasonography) in subjects with critical illness compared to early mobilization and continuous protein delivery only.
Study design: Randomised controlled trial, not single blinded.
Study population: All critically ill adults who were expected to stay at least 72 hours on the ICU.
Intervention (if applicable): Intervention group: Optimal feeding (proteins 1.5 g/kg), early mobilization (3 times a day), directly after mobilization additional 15 grams of proteins. Control group: Optimal feeding (proteins 1.5 g/kg) and early mobilization (3 times a day).
Main study parameters/endpoints: The main study parameter is the percent change in muscle thickness of the mid-upper arm, forearm and thigh measured by ultrasonography, from baseline to ICU admission.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
The largest part of the intervention is standard care. The extra burden is a weekly ultrasonography and Biva measurement. Both are non-invasive measurements, performed at patient's bedside and ready within a few minutes. Next a 6-item questionnaire is done 3 times, these questionnaire takes 5 minutes. The additional 45 grams of protein is within the safe range of 2-2.5 g/kg (since the optimal feeding of protein is set on 1.5 g/kg).
The possible benefit is more preservation of muscle mass during ICU admission.
|- Main changes (audit trail)|
|- RECORD||2-feb-2018 - 18-feb-2018|