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Nutrition Supplementation in Cardiovascular Surgery Patients (NutriSuP CVS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02961205
Recruitment Status : Recruiting
First Posted : November 10, 2016
Last Update Posted : March 15, 2019
Information provided by (Responsible Party):
Lawson Health Research Institute

Brief Summary:
This randomized controlled pilot study evaluates the use of oral nutritional supplementation in nutritionally at-risk cardiovascular surgery patients. The oral nutrition supplement is given for 30 days prior to surgery, continuing throughout their surgical hospitalization and ends at hospital discharge. Half of the participants will receive the oral nutritional supplement and the other half will not.

Condition or disease Intervention/treatment Phase
Malnutrition Dietary Supplement: Oral Nutritional Supplementation Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nutrition Supplementation in Cardiovascular Surgery Patients-A Randomized Controlled Pilot Trial
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Require cardiovascular surgery
  2. Have been assessed in a pre-operative clinic
  3. Have an intermediate or high risk Society of Thoracic Surgeons (STS) score
  4. Malnutrition Universal Screening Tool (MUST) score of >1.

Exclusion Criteria:

  1. Require urgent/emergent cardiovascular surgery
  2. Have advanced symptomatic angina or heart failure
  3. Are designated palliative care
  4. Are currently suffering from refeeding syndrome
  5. Have a pre-existing medical condition that prevents oral intake of full fluids
  6. Are on a fluid restricted diet
  7. Are unable to walk prior to current illness
  8. Have a current diagnosis of diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome
  9. Are pregnant or currently breastfeeding.

Information from the National Library of Medicine

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 identifier (NCT number): NCT02961205

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Contact: Stephanie N Handsor, BA 519-685-8500 ext 34390
Contact: Adam Rahman, MD FRCPC 519-685-8500 ext 64320

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Canada, Ontario
LHSC-University Hospital Recruiting
London, Ontario, Canada, N6A 5A5
Contact: Stephanie N Handsor, BA    519-685-8500 ext 34390   
Sponsors and Collaborators
Lawson Health Research Institute
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Principal Investigator: Adam Rahman, MD FRCPC St. Joseph's Health Care, London ON

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Responsible Party: Lawson Health Research Institute Identifier: NCT02961205     History of Changes
Other Study ID Numbers: INN16-003
First Posted: November 10, 2016    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Nutrition Disorders