Acute Kidney Injury Requiring Renal Replacement Therapy and Critical Illness Myopathy: A Prospective Observational Trial
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Acute kidney injury (AKI), the abrupt loss of kidney function, is a common complication that affects more than half of all 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 who require renal replacement therapy (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 our preliminary data suggests that RRT in the ICU may exacerbate muscle dysfunction through the removal of large quantities of amino acids from the patient's plasma. In this proposal we plan to determine whether patients with AKI-RRT have greater lean muscle loss over 1 week than historic critically ill controls, whether patients with AKI-RRT have diminished recovery of muscle mass and function at one and three months following discharge compared to matched controls, and whether changes in plasma levels of amino acids during hospitalization correlate with loss of muscle function or lack of recovery.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| AKI-RRT These patients are those with acute kidney injury requiring renal replacement therapy. |
Procedure: Observational study of patients initiated on RRT
Patients who are determined by the non-research hospital providers to need RRT.
|
| Controls Controls matched to AKI-RRT patients based on age within 10 years, sex, and ICU length of stay (within 2 days) |
Outcome Measures
Primary Outcome Measures
- ICU Stage: Change in Rectus Femoris Cross-sectional Area [7 days]
Muskuloskeletal ultrasound will measure RF CSA at the time of RRT initiation, and at 7 days thereafter
- Muscle cross sectional area- 1 month [1 month]
RF CSA
- Muscle cross sectional area- 3 months [3 months]
RF CSA
- Muscle Strength - knee extensor and dorsiflexion - 1 month [1 month]
2) Maximal isometric knee extensor and dorsiflexion muscle strength measured as peak force production and rate of force development
- Muscle Strength - knee extensor and dorsiflexion - 3 month [3 months]
2) Maximal isometric knee extensor and dorsiflexion muscle strength measured as peak force production and rate of force development
- Grip strength - 1 month [1 months]
3) Maximal isometric grip strength
- Grip Strength - 3 months [3 months]
3) Maximal isometric grip strength
- Muscle Strength - MRC-ss - 1 month [1 month]
Medical Research Council sum score (MRC-ss),
- Muscle Strength - MRC-ss - 3 months [3 months]
Medical Research Council sum score (MRC-ss),
- Physical Function - SPPB - 1 month [1 month]
Short Performance Physical Battery
- Physical Function - SPPB - 3 months [3 months]
Short Performance Physical Battery
- Physical Function - 6MWT - 1 month [1 month]
Six-minute walk test
- Physical Function - 6MWT - 3 months [3 months]
Six-minute walk test
- Physical Function - CFS - 1 month [1 month]
Clinical Frailty Scale
- Physical Function - CFS - 3 months [3 months]
Clinical Frailty Scale
- Quality of Life determined by EQ-5D-5L questionnaire - 1 month [1 month]
EQ-5D-5L questionnaire
- Quality of Life determined by EQ-5D-5L questionnaire - 3 months [3 months]
EQ-5D-5L questionnaire
- Quality of Life determined by FACIT-fatigue questionnaire - 1 month [1 month]
FACIT-fatigue questionnaire
- Quality of Life determined by FACIT-fatigue questionnaire - 3 months [3 months]
FACIT-fatigue questionnaire
Secondary Outcome Measures
- ICU Stage: Changes in Metabolome [7 days]
We will use metabolomics to determine changes in the metabolome before and after RRT initiation.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
18 years old
-
On mechanical ventilation
-
AKI requiring RRT initiated within 72 hours of ICU admission.
Exclusion Criteria:
-
RRT of any kind at any time prior to ICU admission
-
underlying muscle disorders or muscle atrophy including quadriplegia or hemiplegia, history of stroke with residual muscle deficits, liver cirrhosis, alcohol dependence, active malignancy within 1 year, burns, or other baseline neuromuscular disease
-
pregnant patients
-
anticipated inability to engage in weight-bearing testing after discharge (e.g., traumatic/orthopedic surgery).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Iowa | Iowa City | Iowa | United States | 52242 |
| 2 | University of Kentucky | Lexington | Kentucky | United States | 40506 |
| 3 | University of New Mexico | Albuquerque | New Mexico | United States | 87106 |
Sponsors and Collaborators
- University of Iowa
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 202002328