Effect of EPA and HMB on Strength in ICU Patients
কীওয়ার্ডস
বিমূর্ত
বর্ণনা
Objectives. There is a single objective for this study, namely, to determine if early administration of either EPA or HMB can prevent or reverse the development of respiratory muscle weakness in critically ill, mechanically ventilated patients. The investigators plan to randomize patients accepted into this protocol to administration of either a control (saline enteral control solution), EPA administration (enteral EPA), HMB (enteral HMB), or a combination of EPA and HMB. Drugs will be administered for 10 days and measurements of diaphragm and quadriceps strength and size will be performed immediately before (day 0) and immediately after (day 11) the period of drug administration. A third set of measurements (diaphragm and quadriceps strength and size) will be performed on day 21. Vastus lateralis muscle biopsies will also be taken on days 0 and 11; no biopsy will be performed for day 21 assessments. The investigators will also perform a chart review and assess ventilator mechanics (respiratory system static compliance and inspiratory airway resistance) at the time of the initial strength assessment. Patient outcomes (time on mechanical ventilation and mortality) will also be recorded. The investigators would expect that mean diaphragm strength and limb muscle strength measurements will be similar for four groups immediately before initiation of drug administration. The hypothesis will be supported if, post drug administration, diaphragm and limb muscle strength are higher for patients receiving EPA and/or HMB than the control group receiving no active drug.
Study Design.
The basic study design is to:
1. measure magnetic stimulated Pdi twitch and quadriceps strength and size, obtain a muscle biopsy from the vastus lateralis of the quadriceps, determine respiratory system compliance, determine airway resistance, and perform a chart review,
2. randomize patients to treatment with either: control solutions (30 ml of enteral saline solution every 12 hours), EPA (30 ml of enteral solution containing 1000 mg of EPA every 12 hours), HMB (30 ml of enteral solution containing 1500 mg HMB every 12 hours) or both EPA (30 ml of enteral solution containing 1000 mg of EPA every 12 hours) and HMB (30 ml of enteral solution containing 1500 mg HMB every 12 hours).
3. continue drugs for 10 days then
4. on day 11 remeasure magnetic stimulated Pdi twitch and quadriceps strength, repeat measurements of diaphragm and quadriceps size (i.e. thickness), repeat the vastus lateralis muscle biopsy, determine respiratory system compliance, determine airway resistance, and perform a chart review.
5. on day 21 remeasure magnetic stimulated Pdi twitch and quadriceps strength, and repeat measurements of diaphragm and quadriceps size (i.e. thickness), and perform another chart review.
For each chart review the investigators will obtain the following information: age, sex, diagnoses, reason for institution of mechanical ventilation, vital signs, bedside parameters of mechanical ventilation use (including mode of ventilation, duration of ventilation, level of oxygen, breath volume and rate, % triggered breaths), most recent arterial blood gas values, chest radiograph readings, recorded assessments of limb muscle strength and mental status.
Study Population. Adult patients requiring mechanical ventilation for more than 24 hours in one of the University of Kentucky adult ICU's will be asked to participate. Patients will be excluded if: (a) the physician caring for the patient determines that the patient is too unstable to tolerate these measurements, (b) if the patient requires high dose pressors (more than 15 mcg/min of norepinephrine or more than 15 mg/kg/min of dopamine), (c) if the patient requires more than 80% FiO2 or more than 15 cm H2O of PEEP, (d) if the patient has a cardiac pacemaker or implanted defibrillator, (e) if the patient has received neuromuscular blocking agents within the 48 hours preceding testing or has a known preexisting muscular disease, (f) if the patient has a recent history of variceal bleeding, and (g) if the patient is excessively sedated or mentally obtunded as judged by an inability to follow verbal commands. The investigators will also not study pregnant females, prisoners, or institutionalized decisionally impaired patients.
The goals are to recruit 80 patients into the study over a 24 month period (5 patients/month, 20 patients per experimental group). The investigators will study patients regardless of sex, race, or adult age. It is hoped that sufficient minorities and women will be studied so that the subject population is representative of the general patient population, but the investigators will be somewhat constrained by the numbers of available patients and the day to day makeup of the patient population in the UK ICU's. Inclusion of minorities and women will make the study results more generally applicable.
তারিখ
সর্বশেষ যাচাই করা হয়েছে: | 05/31/2020 |
প্রথম জমা দেওয়া: | 01/03/2011 |
আনুমানিক তালিকাভুক্তি জমা দেওয়া হয়েছে: | 01/03/2011 |
প্রথম পোস্ট: | 01/04/2011 |
সর্বশেষ আপডেট জমা দেওয়া হয়েছে: | 06/17/2020 |
সর্বশেষ আপডেট পোস্ট: | 06/21/2020 |
আসল অধ্যয়ন শুরুর তারিখ: | 12/31/2013 |
আনুমানিক প্রাথমিক সমাপ্তির তারিখ: | 01/19/2020 |
আনুমানিক অধ্যয়ন সমাপ্তির তারিখ: | 01/19/2020 |
অবস্থা বা রোগ
হস্তক্ষেপ / চিকিত্সা
Drug: HMB, hydroxymethylbutyrate
Drug: EPA, eicosapentaenoic acid
Drug: Control, to be given saline solution
পর্যায়
বাহু গ্রুপ
বাহু | হস্তক্ষেপ / চিকিত্সা |
---|---|
Placebo Comparator: Control, to be given saline solution Intervention: This group will be given saline (30 ml every 12 hours) for 10 days | Drug: Control, to be given saline solution Control |
Experimental: EPA, eicosapentaenoic acid This group will be given 1000 mg EPA every 12 hours for 10 days | |
Experimental: HMB, hydroxymethylbutyrate This arm will be given HMB (1500 mg) every 12 hours for 10 days. | |
Experimental: EPA and HMB Intervention: This group will be given EPA (1000 mg every 12 hours given via the GI tract) and HMB (1500 mg every 12 hours given via the GI tract) for 10 days. |
যোগ্যতার মানদণ্ড
বয়স অধ্যয়নের জন্য যোগ্য | 18 Years প্রতি 18 Years |
লিঙ্গ অধ্যয়নের জন্য যোগ্য | All |
স্বাস্থ্যকর স্বেচ্ছাসেবীদের গ্রহণ করে | হ্যাঁ |
নির্ণায়ক | Inclusion Criteria: - Adult patients requiring mechanical ventilation for more than 24 hours in one of the University of Kentucky adult ICU's Exclusion Criteria: - The physician caring for the patient determines that the patient is too unstable to tolerate these measurements, - If the patient requires high dose pressors (more than 15 mcg/min of norepinephrine or more than 15 mg/kg/min of dopamine), - If the patient requires more than 80% FiO2 or more than 15 cm H2O of PEEP, - If the patient has a cardiac pacemaker or implanted defibrillator, - If the patient has received neuromuscular blocking agents within the 48 hours preceding testing or has a known preexisting muscular disease, - If the patient has a recent history of variceal bleeding, - If the patient is excessively sedated or mentally obtunded as judged by an inability to follow verbal commands. - We will not study pregnant females, prisoners, or institutionalized decisionally impaired patients. |
ফলাফল
প্রাথমিক ফলাফল ব্যবস্থা
1. Improvement of skeletal muscle strength for one of the drugs compared to placebo [By the second strength measurement (11 days)]
মাধ্যমিক ফলাফলের ব্যবস্থা
1. duration of mechanical ventilation [weeks]