Critical Illness Myopathy and Trajectory of Recovery in Acute Kidney Injury (AKI) Requiring Continuous Renal Replacement Therapy (CRRT): A Prospective Observational Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 3
- 主要终点
- Muscle Strength - MRC-ss at post-discharge outpatient visit
研究概览
简要总结
The purpose of this study is to determine whether patients with acute kidney injury requiring renal replacement therapy have a higher incidence of muscle wasting than controls and whether the course of recovery is longer compared to controls.
详细描述
Acute kidney injury (AKI), the abrupt loss of kidney function, is a common complication that affects more than half of all intensive care unit (ICU) admissions, and it is associated with substantially higher rates of morbidity and mortality in both the short- and the long-term. This is especially true in patients with AKI requiring renal replacement therapy (AKI-RRT), also known as dialysis. An understudied mechanism by which AKI-RRT may contribute to poor clinical outcomes, both in the hospital and after discharge, is through its impact on muscle mass and muscle function. AKI of any severity is known to alter tissue utilization of amino acids, and preliminary data suggest that RRT in the ICU may exacerbate muscle dysfunction through the removal of large quantities of amino acids from the patient's plasma. This study will determine whether patients with AKI-RRT have greater lean muscle loss over 1 week than historical critically ill controls, whether patients with AKI-RRT have diminished recovery of muscle mass and function at 1-3 months following discharge compared to controls, and whether changes in plasma levels of amino acids during hospitalization correlate with loss of muscle function or lack of recovery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18 years old
- •AKI requiring CRRT, with enrollment within 48 hours of CRRT initiation
排除标准
- •ICU admission for >7 days
- •RRT of any kind at any time prior to ICU admission
- •Chronic kidney disease (CKD) with estimated glomerular filtration rate <20 mL/min/1.73 m2 as calculated by the 2021 CKD-EPI equation
- •underlying muscle disorders or muscle atrophy such as quadriplegia or hemiplegia, stroke with residual motor deficits, end-stage liver disease, active alcohol use disorder, active malignancy (other than non-melanoma skin cancer) within 1 year, burns, or other baseline neuromuscular disease
- •pregnancy
- •concomitant use of other extracorporeal support devices such as ventricular assist devices or extracorporeal membrane oxygenation
- •anticipated inability to engage in weight-bearing testing after discharge (e.g., trauma or orthopedic surgery)
- •subjects will be ineligible for outpatient testing if they remain on RRT in the week prior to the research appointment
结局指标
主要结局
Muscle Strength - MRC-ss at post-discharge outpatient visit
时间窗: 1-3 months
MRC-ss is a measure of global peripheral muscle strength that is the current clinical standard for diagnosing ICU-acquired weakness. Muscle strength is assessed by physical exam and rated on an ordinal scale (0-5) at six bilateral muscle groups: shoulder abductors, elbow flexors, wrist extensors, hip flexors, knee extensors, and ankle dorsiflexors.
Muscle Strength - knee extension by HHD at post-discharge outpatient visit
时间窗: 1-3 months
Maximal isometric knee extensor muscle strength as measured by HHD.
Muscle Strength - Grip Strength at post-discharge outpatient visit
时间窗: 1-3 months
Maximal isometric grip strength as measured by HGD
Return to driving
时间窗: 1-3 months
Yes / No outcome assessed at the outpatient follow-up visit
Return to work or hobby
时间窗: 1-3 months
Yes / No outcome assessed at the outpatient follow-up visit
Physical Function - Clinical Frailty Scale (CFS) at post-discharge outpatient visit
时间窗: 1-3 months
CFS is a widely adopted judgement-based tool to screen for frailty and to broadly stratify degrees of fitness and frailty.
RF mT at post-discharge outpatient visit
时间窗: 1-3 months
RF mT as assessed by MSKUS will be measured at outpatient follow-up visit.
ICU Stage: rectus femoris (RF) cross-sectional area (CSA)
时间窗: 7 days
RF CSA as assessed by musculoskeletal ultrasound (MSKUS) will be measured at day 0 (study enrollment within 48 hours of CRRT initiation), at day 3, and at day 7 (or at ICU discharge if before day 7).
ICU Stage: ICU Mobility Scale
时间窗: 7 days
The ICU Mobility Scale is an 11-point scale ranging from 0-10 which involves scoring a patient's maximum level of mobility in the prior 24-hour period. The ICU Mobility Scale will be performed at the same 3 time points as the MSKUS assessments.
Muscle Strength - Medical Research Council Sum-score (MRC-ss) at discharge
时间窗: 1 month
MRC-ss is a measure of global peripheral muscle strength that is the current clinical standard for diagnosing ICU-acquired weakness. Muscle strength is assessed by physical exam and rated on an ordinal scale (0-5) at six bilateral muscle groups: shoulder abductors, elbow flexors, wrist extensors, hip flexors, knee extensors, and ankle dorsiflexors.
Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Questionnaire at post-discharge outpatient visit
时间窗: 1-3 months
The FACIT-F scale is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function.
ICU Stage: RF muscle thickness (mT)
时间窗: 7 days
RF mT as assessed by MSKUS will be measured at day 0 (study enrollment within 48 hours of CRRT initiation), at day 3, and at day 7 (or at ICU discharge if before day 7).
ICU Stage: RF echo intensity (EI)
时间窗: 7 days
RF EI as assessed by MSKUS will be measured at day 0 (study enrollment within 48 hours of CRRT initiation), at day 3, and at day 7 (or at ICU discharge if before day 7).
RF CSA at discharge
时间窗: 1 month
RF CSA as assessed by MSKUS will be measured at hospital discharge.
RF EI at discharge
时间窗: 1 month
RF EI as assessed by MSKUS will be measured at hospital discharge.
RF CSA at post-discharge outpatient visit
时间窗: 1-3 months
RF CSA as assessed by MSKUS will be measured at outpatient follow-up visit.
RF EI at post-discharge outpatient visit
时间窗: 1-3 months
RF mT as assessed by MSKUS will be measured at outpatient follow-up visit.
Muscle Strength - knee extension by hand-held dynamometry (HHD) at hospital discharge
时间窗: 1 month
Maximal isometric knee extensor muscle strength as measured by HHD.
Muscle Strength - Grip Strength at hospital discharge
时间窗: 1 month
Maximal isometric grip strength as measured by hand-grip dynamometry (HGD)
Physical Function - Short Physical Performance Battery (SPPB) at discharge
时间窗: 1 month
SPPB is a performance-based composite test with a total of 12 points including components of balance (side-by-side stand, semi-tandem stand, and full-tandem stand), chair-to-stand test, and 4-meter habitual gait speed used to assess physical function and physical frailty.
Physical Function - 6-minute walk test (6MWT) at post-discharge outpatient visit
时间窗: 1-3 months
The 6MWT assesses the distance a subject can walk in six minutes, providing a global representation of physical function and cardiopulmonary endurance.
36-Item Short Form Health Survey Physical Function Scale (SF-36) at post-discharge outpatient visit
时间窗: 1-3 months
The SF-36 is a 36-item patient-reported survey of health commonly used to evaluate adult patients which contains 8 domains, including a physical function scale based on 10 of the 36 items which has been shown to have high reliability.
RF mT at discharge
时间窗: 1 month
RF mT as assessed by MSKUS will be measured at hospital discharge.
TUG Test at post-discharge outpatient visit
时间窗: 1-3 months
The Timed Up and Go (TUG) test assesses the time (in seconds) for a subject to stand on command from a seated position, walk 3 meters, turn around, walk back to the chair, and sit down, thereby assessing mobility, physical function, and fall risk.
Physical Function - SPPB at post-discharge outpatient visit
时间窗: 1-3 months
SPPB is a performance-based composite test with a total of 12 points including components of balance (side-by-side stand, semi-tandem stand, and full-tandem stand), chair-to-stand test, and 4-meter habitual gait speed used to assess physical function and physical frailty.
Quality of Life testing using EuroQol Group 5-dimension 5-level (EQ-5D-5L) questionnaire at post-discharge outpatient visit
时间窗: 1-3 months
The EQ-5D-5L is a standardized measure of health status developed by the Euro-Qol Group to provide an assessment of health for clinical and economic appraisal.
Hospital Readmission
时间窗: 1-3 months
Yes / No outcome assessed at the outpatient follow-up visit
Emergency Department Visit
时间窗: 1-3 months
Yes / No outcome assessed at the outpatient follow-up visit
次要结局
- ICU Stage: Changes in Plasma Metabolome(7 days)
- ICU Stage: Changes in CRRT Effluent Metabolome(7 days)
研究者
Benjamin Griffin
Assistant Professor
University of Iowa