Nutrition in Patient With Critical Limb Ischemia
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-99
SponsorBoston Medical Center
About this trial
A prospective pilot study examining nutritional supplements among vascular surgery patients with Critical Limb Ischemia (CLI). CLI patients have a high rate of malnutrition and has the potential to benefit greatly from nutritional intervention. The investigators plan to evaluate nutrition and functional status of patients by assessing objective lab values and the use of the hand grip strength test. Providing perioperative nutritional supplements to patients has potentially improved their nutritional status, which in turn may improve the patient's clinical status after surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Critical Limb Ischemia
Disqualifiers
Female patients who are pregnant or lactating
Chronic Kidney Disease Stages 4 and 5
Patients who are on dialysis
Trial design
Design model
Single group
Treatments tested in this trial
Ensure Surgery Immunonutrition Shake
DrugAn FDA approved nutritional supplement. Prepackaged product designed to be administered one week prior to and one week post surgical procedures.
Ensure Enlive Advanced Nutrition Shake
DrugAn FDA approved nutritional supplement. Prepackaged product designed to be administered 2 weeks prior to and 2 weeks post surgical procedure for a period of one week. .
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Nutritional SupplementExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Change in serum albumin levels
Albumin is a carbohydrate-free protein, which constitutes 55% to 65% of total plasma protein. Albumin results can reflect the nutritional status of the body and other problems with the kidney or liver. A normal albumin range is 3.4 to 5.4 g/dL. Albumin levels will be tested on blood samples on each participant obtained at baseline and 30 days after nutritional supplementation. Lower albumin levels are associated with malnutrition
Time frame
baseline and 30 days2
Change in prealbumin levels
Prealbumin is a protein produced by the liver and levels can reflect nutritional status. Normal results for a prealbumin blood test for adults are 15 to 36 milligrams per deciliter (mg/dL). Prealbumin levels will be tested on blood samples on each participant obtained at baseline and 30 days after nutritional supplementation. Lower levels of prealbumin are associated with malnutrition.
Time frame
baseline and 30 days3
Change in transferrin levels
Transferrin is the main protein in the blood that binds to iron and transports it throughout the body. The normal range for transferrin is 170 to 370 mg/dl. Transferrin levels will be tested on blood samples on each participant obtained at baseline and 30 days after nutritional supplementation. Transferrin levels rise with iron deficiency and fall in cases of iron overload.
Time frame
baseline and 30 days4
Change in C-reactive protein levels
C-reactive protein (CRP) is a substance produced by the liver that increases in the presence of inflammation in the body. C-reactive protein levels will be tested on blood samples on each participant obtained at baseline and 30 days after nutritional supplementation. Lower levels are favorable.
Time frame
baseline and 30 daysSecondary outcomes
1
Change in Hand grip strength
A hand dynamometer will be used to measure hand grip strength. Higher values are favorable.
Time frame
baseline and 30 daysOther outcomes
1
Change in ERAS (Enhanced Recovery After Surgery) Malnutrition Screening Test (MST) Scores
The ERAS Malnutrition Screening Test (MST) is a 3 question survey used to evaluate patient's nutritional status. The 3 questions ask about recent weight loss without trying, amount of the weight loss, and whether eating poorly because of a decreased appetite. Scores of 2 or greater indicate risk of malnutrition. Lower scores are favorable.
Time frame
baseline and 30 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Boston Medical Center
Lead sponsor
Vascular & Endovascular Surgery Society
Collaborator
Abbott
Collaborator
Source ClinicalTrials.gov