International Nutrition Survey 2018

Cardiovascular Surgery Clinical Trial

— INS2018  

Official title:

International Nutrition Survey 2018

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03442946
• Other study ID #: 3CARE_BOÄ_18-001
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: May 2022
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Surgery

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto
Germany	University hospital RWTH Aachen	Aachen
Iran, Islamic Republic of	Rajaie Cardiovascular, Medical and Research Center	Tehran
Russian Federation	Meshalkin National Medical Research Center	Novosibirsk
United States	University of Utah Medical Center	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
RWTH Aachen University	Clinical Evaluation Research Unit at Kingston General Hospital

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Iran, Islamic Republic of,  Russian Federation, 

References & Publications (30)

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Cahill NE, Dhaliwal R, Day AG, Jiang X, Heyland DK. Nutrition therapy in the critical care setting: what is "best achievable" practice? An international multicenter observational study. Crit Care Med. 2010 Feb;38(2):395-401. doi: 10.1097/CCM.0b013e3181c02 — View Citation

Compher C, Chittams J, Sammarco T, Nicolo M, Heyland DK. Greater Protein and Energy Intake May Be Associated With Improved Mortality in Higher Risk Critically Ill Patients: A Multicenter, Multinational Observational Study. Crit Care Med. 2017 Feb;45(2):15 — View Citation

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Heyland DK, Dhaliwal R, Day A, Jain M, Drover J. Validation of the Canadian clinical practice guidelines for nutrition support in mechanically ventilated, critically ill adult patients: results of a prospective observational study. Crit Care Med. 2004 Nov — View Citation

Heyland DK, Dhaliwal R, Drover JW, Gramlich L, Dodek P; Canadian Critical Care Clinical Practice Guidelines Committee. Canadian clinical practice guidelines for nutrition support in mechanically ventilated, critically ill adult patients. JPEN J Parenter E — View Citation

Heyland DK, Dhaliwal R, Wang M, Day AG. The prevalence of iatrogenic underfeeding in the nutritionally 'at-risk' critically ill patient: Results of an international, multicenter, prospective study. Clin Nutr. 2015 Aug;34(4):659-66. doi: 10.1016/j.clnu.201 — View Citation

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Nicolo M, Heyland DK, Chittams J, Sammarco T, Compher C. Clinical Outcomes Related to Protein Delivery in a Critically Ill Population: A Multicenter, Multinational Observation Study. JPEN J Parenter Enteral Nutr. 2016 Jan;40(1):45-51. doi: 10.1177/0148607 — View Citation

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Rahman A, Hasan RM, Agarwala R, Martin C, Day AG, Heyland DK. Identifying critically-ill patients who will benefit most from nutritional therapy: Further validation of the "modified NUTRIC" nutritional risk assessment tool. Clin Nutr. 2016 Feb;35(1):158-1 — View Citation

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Stoppe C, McDonald B, Benstoem C, Elke G, Meybohm P, Whitlock R, Fremes S, Fowler R, Lamarche Y, Jiang X, Day AG, Heyland DK. Evaluation of Persistent Organ Dysfunction Plus Death As a Novel Composite Outcome in Cardiac Surgical Patients. J Cardiothorac V — View Citation

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in nutrition adequacy in the ICU	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.	day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10, day 11, day 12