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International Nutrition Survey 2018 (INS2018)

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. Read our disclaimer for details. Identifier: NCT03442946
Recruitment Status : Unknown
Verified December 2019 by Christian Stoppe, University Hospital, Aachen.
Recruitment status was:  Recruiting
First Posted : February 22, 2018
Last Update Posted : December 18, 2019
Clinical Evaluation Research Unit at Kingston General Hospital
Information provided by (Responsible Party):
Christian Stoppe, University Hospital, Aachen

Brief Summary:

Malnutrition is common among critically ill patients, and has negative effects on clinical outcomes. Artificial nutrition therapy in the form of enteral or parenteral nutrition is therefore considered an integral part of standard care. While it has long been widely accepted that it is unethical to withhold nutrition therapy from those at risk of malnutrition, we and our collaborators provide first evidence that nutrition practices significantly influence clinically important outcomes such as length of stay, morbidity and mortality in critically ill patients. Among these, cardiac surgery patients are routinely exposed to significant systemic inflammation due to the need for a cardiopulmonary bypass, which triggers a systemic inflammatory response syndrome. As a consequence, the releases of reactive oxygen and nitrogen species as well as pro-inflammatory cytokines lead to life-threatening complications in cardiac surgical patients. For such patients, aggressive life-sustaining therapies are needed while their organs recover.

Besides, underfeeding is a major issue in this specific patient population. Often nutrition starts late and reaches only low nutrition adequacy. Recent data from our collaborators suggest that providing at least 80% of prescribed amounts of protein and energy is associated with improved clinical outcomes. Achieving this threshold of 80% of prescribed amounts of protein has been shown to be associated with reduced mortality in "at-risk" ICU patients and is more important than achieving energy goals. Despite these benefits, enteral or parenteral feeding should always be adopted with caution, as nutrition practices themselves are not per se without adverse effects or risks. Making decisions regarding the most effective and safe means of feeding patients in the ICU can be challenging, and consequently considerable variation exists in nutrition practices in this setting, whereas no guidelines yet exists specific of cardiac surgery patients.

Clinical Practice Guidelines (CPGs) are "systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances", and therefore aid in the implementation of evidence-based medicine. The Canadian Clinical Practice Guidelines for Nutrition Therapy in Mechanically Ventilated, Critically Ill Adult Patients published in 2003 by our close collaborator Prof Heyland and most recently updated in 2015, sought to improve nutrition practices in ICUs across Canada and worldwide by providing guidance to select and deliver the most appropriate form of nutrition therapy at the appropriate time via the most appropriate route. A validation study prior to the widespread dissemination of the Canadian Critical Care Nutrition CPGs concluded that adoption of the recommendations should lead to improved nutrition practices and potentially to better patient outcomes [24]. To change clinical practice, attention must extend beyond initial development to guideline implementation, dissemination and evaluation. Implementation strategies will vary by ICU, health care system and region and should be guided by local factors including the ICU's barriers and facilitators to following best practice. Evaluating and monitoring nutrition performance and focussing on different groups of critically ill patients, should be part of an on-going improvement strategy to improve nutrition care and clinical outcome. The few studies regarding the process of knowledge translation conducted in the ICU setting have demonstrated by our collaborators that guidelines and guideline implementation strategies improve the processes, outcomes, and the costs of caring for critically ill patients.

Condition or disease
Cardiovascular Surgery

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: International Nutrition Survey 2018
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Patients in need of a cardiovascular surgery will be included in this observational study. The focus is on the nutrition therapies provided to these critically ill patients according to institutional or international nutrition guidelines, what ever applies for the participating sites.

Primary Outcome Measures :
  1. Change in nutrition adequacy in the ICU [ Time Frame: day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10, day 11, day 12 ]
    Adequacy of nutrition (an indicator of overall performance) will be calculated as the amount of calories or protein received (from either enteral (EN) or appropriate parenteral nutrition (PN) but not oral) plus propofol, divided by the amount prescribed as per the baseline assessment and expressed as a percentage. Days without EN or PN will be included and counted as 0% adequacy. Days after permanent progression to exclusive oral intake will be excluded from the calculation of nutritional adequacy. We arbitrarily selected >80% nutritional adequacy as an indicator of high performance.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patients in need of a cardiovascular surgery and meeting the inclusion criteria are considered to be eligible for this study.

Inclusion Criteria:

  • Age ≥ 18 years
  • Patients undergoing cardiac surgery
  • Mechanically ventilated within 48 hours of ICU admission
  • Stay on ICU > 72 hours

Exclusion Criteria:

  • None

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): NCT03442946

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Contact: Elena Laaf +4924180 ext 37942
Contact: Sebastian Wendt +4924180 ext 37715

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United States, Utah
University of Utah Medical Center Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Andrea Ovard         
Sunnybrook Health Sciences Centre Recruiting
Toronto, Canada
Contact: Andrea Ho         
University hospital RWTH Aachen Recruiting
Aachen, Germany
Contact: Elena Laaf         
Iran, Islamic Republic of
Rajaie Cardiovascular, Medical and Research Center Not yet recruiting
Tehran, Iran, Islamic Republic of
Contact: Baran Hashemi, Ass. Prof.   
Russian Federation
Meshalkin National Medical Research Center Recruiting
Novosibirsk, Russian Federation
Contact: Sergey Efremov         
Sponsors and Collaborators
RWTH Aachen University
Clinical Evaluation Research Unit at Kingston General Hospital
Additional Information:

Publications of Results:

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Responsible Party: Christian Stoppe, PD Dr. med. Christian Stoppe, University Hospital, Aachen Identifier: NCT03442946    
Other Study ID Numbers: 3CARE_BOÄ_18-001
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: December 18, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christian Stoppe, University Hospital, Aachen:
nutrition guidelines
critical care
nutrition therapy