Nutrition Supplementation in Cardiovascular Surgery Patients (NutriSuP CVS)
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|ClinicalTrials.gov Identifier: NCT02961205|
Recruitment Status : Recruiting
First Posted : November 10, 2016
Last Update Posted : November 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Malnutrition||Dietary Supplement: Oral Nutritional Supplementation||Not Applicable|
Cardiovascular surgery (CVS) is a resource intensive modality in the treatment of coronary artery disease and valvular heart disease. CVS patients who are malnourished experience increased duration of cardiopulmonary bypass, post-operative infections, impaired wound healing, muscle wasting, longer lengths of intensive care unit (ICU) and hospital stay, higher readmission rates, higher treatment costs and marked increases in mortality. Despite the devastating effects of malnutrition in these patients, physicians and health care practitioners are poor in respect to identification, monitoring and treatment of malnutrition.
In two large tertiary hospitals in Ontario, this will be a randomized trial of a novel nutritional pathway to rapidly identify at-risk CVS patients pre-operatively, and then provide oral nutritional supplementation (ONS) during the 30 days prior to surgery, then continue supplementation throughout hospitalization until discharge. Meaningful patient-centered and economic outcomes will be examined.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Nutrition Supplementation in Cardiovascular Surgery Patients-A Randomized Controlled Pilot Trial|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2019|
Experimental: Oral Nutritional Supplementation
Patients randomized to the interventional arm will receive Ensure Enlive (Abbott Nutrition), a high energy, high protein oral supplement.
Dietary Supplement: Oral Nutritional Supplementation
Participants randomized to this arm will receive one bottle of Ensure Enlive 2 times per day, for 30 days prior to their cardiovascular surgery, plus continue their usual diet.
After their CVS and throughout their hospitalization they will continue to receive 2 bottles of Ensure Enlive per day, plus the standard hospital menu (3 meals per day, plus snacks or as ordered by the medical team), ending at hospital discharge.
Other Name: Ensure Enlive
No Intervention: Standard of care
Patients randomized to the control arm will continue their usual diet.
- Recruitment [ Time Frame: 1 year ]This pilot study will be considered as successfully demonstrating feasibility of recruitment if 60 participants are recruited over 12 months. The overarching objective of this pilot study is to prove feasibility of recruitment and of the protocol in order to continue to a large phase 3 trial.
- Nutrition Status [ Time Frame: 30 days post surgery date ]The Malnutrition Universal Screening Tool (MUST) will be the method of assessment. The MUST is a five-step screening tool to identify adults, who are at-risk of malnutrition.
- Functional Performance [ Time Frame: 30 days post surgery date ]Six Minute Walk Test will be the method of assessing physical function and therapeutic response to the intervention. Patients will be asked to walk as far as possible in six minutes, going at their own pace and resting as needed, along a marked walkway.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02961205
|Contact: Stephanie N Handsor, BA||519-685-8500 ext firstname.lastname@example.org|
|Contact: Adam Rahman, MD FRCPC||519-685-8500 ext email@example.com|
|London, Ontario, Canada, N6A 5A5|
|Contact: Stephanie N Handsor, BA 519-685-8500 ext 34390 firstname.lastname@example.org|
|Principal Investigator:||Adam Rahman, MD FRCPC||St. Joseph's Health Care, London ON|