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Clinical trial

Perioperative Nutritional Optimization in Patients With Critical Limb Ischemia

ID
Name
H-37324
Description
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.
Trial arms
Trial start
2018-10-02
Estimated PCD
2024-07-01
Trial end
2024-07-01
Status
Recruiting
Phase
Early phase I
Treatment
Ensure Surgery Immunonutrition Shake
An FDA approved nutritional supplement. Prepackaged product designed to be administered one week prior to and one week post surgical procedures.
Arms:
Nutritional Supplement
Ensure Enlive Advanced Nutrition Shake
An 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. .
Arms:
Nutritional Supplement
Size
30
Primary endpoint
Change in serum albumin levels
baseline and 30 days
Change in prealbumin levels
baseline and 30 days
Change in transferrin levels
baseline and 30 days
Change in C-reactive protein levels
baseline and 30 days
Eligibility criteria
Inclusion Criteria: * Critical Limb Ischemia Exclusion Criteria: * Female patients who are pregnant or lactating * Chronic Kidney Disease Stages 4 and 5 * Patients who are on dialysis
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Potential subjects with potential malnutrition and critical limb ischemia.', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}
Updated at
2024-03-26

1 organization

2 products

3 indications

Organization
Boston Medical Center
Product
Ensure Surgery Immunonutrition Shake
Indication
Critical Limb Ischemia
Indication
Malnutrition
Indication
Dietary Supplements
Product
Enlive Advanced Nutrition Shake