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due to lack of enrollment and sponsored funding for this project
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| Name | Class |
|---|---|
| Abbott Nutrition | INDUSTRY |
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This non-randomized pilot study aims to investigate whether a protein rich nutritional shake (Ensure Enlive) given to patients pre-transplant will decrease skeletal muscle loss (measured by quadriceps ultrasound) and improve nutritional state (measured by Nutritional Risk Index). A nutritional supplement would be a cost-effective solution to treat malnutrition, a known risk factor implicated in poor outcomes for lung transplant recipients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Nutritional shakes, Ensure Enlive, twice per day orally in patients awaiting lung transplant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ensure Enlive | Dietary Supplement | Ensure Enlive shake twice a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of nutritional supplementation on skeletal muscle mass as assessed by ultrasound of the quadriceps | To examine the effect of nutritional supplementation on skeletal muscle mass in patients with end stage lung disease who are awaiting lung transplant, measured by ultrasound of the quadriceps. | Pre-transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of nutritional supplementation on Nutritional Risk index as assessed by serum albumin level | To examine the effect of nutritional supplementation on Nutritional Risk index, measured by serum albumin level. | Pre-transplant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Errol Bush, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30447192 | Background | Hsu J, Krishnan A, Lin CT, Shah PD, Broderick SR, Higgins RSD, Merlo CA, Bush EL. Sarcopenia of the Psoas Muscles Is Associated With Poor Outcomes Following Lung Transplantation. Ann Thorac Surg. 2019 Apr;107(4):1082-1088. doi: 10.1016/j.athoracsur.2018.10.006. Epub 2018 Nov 14. | |
| 23664761 | Background | Chamogeorgakis T, Mason DP, Murthy SC, Thuita L, Raymond DP, Pettersson GB, Blackstone EH. Impact of nutritional state on lung transplant outcomes. J Heart Lung Transplant. 2013 Jul;32(7):693-700. doi: 10.1016/j.healun.2013.04.005. Epub 2013 May 9. |
| Label | URL |
|---|---|
| Sarcopenia of the Psoas Muscles Is Associated With Poor Outcomes Following Lung Transplantation | View source |
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Data sharing will be
Data will be available upon completion of the study analysis
Upon request to principal investigator
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Ensure Enlive, Nutritional shake, twice a day
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| Impact of nutritional state on lung transplant outcomes | View source |