Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of this study is to characterize the immune-modulatory effects of arginine-rich nutritional supplements in patients undergoing surgery. Numerical and functional changes of all circulating immune cells will be assessed with mass cytometry.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arginine rich nutritional supplement | Active Comparator | 237 ml of an arginine rich nutritional supplement 4 times a day for the five days preceding surgery. |
|
| No nutritional supplement | No Intervention | No specific nutritional requirements have to be met in this group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| An arginine rich nutritional supplement | Dietary Supplement | Impact is a nutritional supplement formulated with 18 grams of protein per serving and 24 essential nutrients including arginine. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in fractional representation of myeloid-derived suppressor cells (MDSC) from baseline. | The fraction of MDSCs will be quantified. | Base line (prior to 1st administration of arginine supplement), immediately prior to surgery, 24 hours, 72 hours and 120 hours after surgery. |
| Functional status change of myeloid-derived suppressor cells (MDSC) from baseline. | Intracellular phosphorylation events in MDSCs will be quantified. | Base line (prior to 1st administration of arginine supplement), immediately prior to surgery, 24 hours, 72 hours and 120 hours after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of surgery on clinical recovery using multiple clinical measures and a validated questionnaire. | Outcome measures include the 1) Surgical Recovery Scale, 2) Pain (11-point numerical pain rating scale), 3) Consumption of analgesic drugs. | Daily for duration of hospital stay, then every 3 days trough postoperative week 5. |
| Measure | Description | Time Frame |
|---|---|---|
| Fractional and absolute expansion/contraction of cluster of differentiation 4 (CD4)+ and cluster of differentiation 8 (CD8)+ cells | Base line (prior to 1st administration of arginine supplement), immediately prior to surgery, 24 hours, 72 hours and 120 hours after surgery. | |
| Functional status of cluster of differentiation 4 (CD4)+ and cluster of differentiation 8 (CD8)+ cells |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Martin S Angst, MD | Stanford University SOM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Hospital | Stanford | California | 84305 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Base line (prior to 1st administration of arginine supplement), immediately prior to surgery, 24 hours, 72 hours and 120 hours after surgery. |
| Functional potency of cluster of differentiation 4 (CD4)+ and cluster of differentiation 8 (CD8)+ cells | Base line (prior to 1st administration of arginine supplement), immediately prior to surgery, 24 hours, 72 hours and 120 hours after surgery. |
| Capacity of cluster of differentiation 4 (CD4)+ and cluster of differentiation 8 (CD8)+ cells | Base line (prior to 1st administration of arginine supplement), immediately prior to surgery, 24 hours, 72 hours and 120 hours after surgery. |