International Nutrition Survey 2018

NCT03442946 | Completed

• 1 other identifier: 3CARE_BOÄ_18-001
• Study Type: observational
• Target: 280
• Locations: 5 countries
• Sites: 5

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.

Conditions

Cardiovascular Surgery

Keywords

nutrition guidelines; critical care; cardiovascular; nutrition therapy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

INS

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• RWTH Aachen University: lead
• Clinical Evaluation Research Unit at Kingston General Hospital: collaborator

Study Sites (5)

University of Utah Medical Center

Salt Lake City, Utah, 84132, United States

Location

Sunnybrook Health Sciences Centre

Toronto, Canada

Location

University hospital RWTH Aachen

Aachen, Germany

Location

Rajaie Cardiovascular, Medical and Research Center

Tehran, Iran

Location

Meshalkin National Medical Research Center

Novosibirsk, Russia

Location

Related Publications (30)

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• Heyland DK, Drover JW, Dhaliwal R, Greenwood J. Optimizing the benefits and minimizing the risks of enteral nutrition in the critically ill: role of small bowel feeding. JPEN J Parenter Enteral Nutr. 2002 Nov-Dec;26(6 Suppl):S51-5; discussion S56-7. doi: 10.1177/014860710202600608.

  PMID: 12405623 RESULT

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  PMID: 12352035 RESULT

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  PMID: 15474870 RESULT

• Stoppe C, Meybohm P, Coburn M, Goetzenich A. [Cardioprotection in cardiac surgical patients : Everything good comes from the heart]. Anaesthesist. 2016 Mar;65(3):169-82. doi: 10.1007/s00101-016-0141-z. German.

  PMID: 26915019 RESULT

• Kim BS, Jacobs D, Emontzpohl C, Goetzenich A, Soppert J, Jarchow M, Schindler L, Averdunk L, Kraemer S, Marx G, Bernhagen J, Pallua N, Schlemmer HP, Simons D, Stoppe C. Myocardial Ischemia Induces SDF-1alpha Release in Cardiac Surgery Patients. J Cardiovasc Transl Res. 2016 Jun;9(3):230-238. doi: 10.1007/s12265-016-9689-x. Epub 2016 Apr 7.

  PMID: 27055858 RESULT

• Dreymueller D, Goetzenich A, Emontzpohl C, Soppert J, Ludwig A, Stoppe C. The perioperative time course and clinical significance of the chemokine CXCL16 in patients undergoing cardiac surgery. J Cell Mol Med. 2016 Jan;20(1):104-15. doi: 10.1111/jcmm.12708. Epub 2015 Oct 23.

  PMID: 26499307 RESULT

• 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 Vasc Anesth. 2016 Jan;30(1):30-8. doi: 10.1053/j.jvca.2015.07.035. Epub 2015 Jul 29.

  PMID: 26847748 RESULT

• Drover JW, Cahill NE, Kutsogiannis J, Pagliarello G, Wischmeyer P, Wang M, Day AG, Heyland DK. Nutrition therapy for the critically ill surgical patient: we need to do better! JPEN J Parenter Enteral Nutr. 2010 Nov-Dec;34(6):644-52. doi: 10.1177/0148607110372391.

  PMID: 21097764 RESULT

• 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):158-162. doi: 10.1016/j.clnu.2015.01.015. Epub 2015 Jan 28.

  PMID: 25698099 RESULT

• Heyland DK, Cahill N, Day AG. Optimal amount of calories for critically ill patients: depends on how you slice the cake! Crit Care Med. 2011 Dec;39(12):2619-26. doi: 10.1097/CCM.0b013e318226641d.

  PMID: 21705881 RESULT

• 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: 10.1177/0148607115583675. Epub 2015 Apr 21.

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• Burns SM, Earven S, Fisher C, Lewis R, Merrell P, Schubart JR, Truwit JD, Bleck TP; University of Virginia Long Term Mechanical Ventilation Team. Implementation of an institutional program to improve clinical and financial outcomes of mechanically ventilated patients: one-year outcomes and lessons learned. Crit Care Med. 2003 Dec;31(12):2752-63. doi: 10.1097/01.CCM.0000094217.07170.75.

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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.0b013e3181c0263d.

  PMID: 19851094 RESULT

• 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):156-163. doi: 10.1097/CCM.0000000000002083.

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• 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.2014.07.008. Epub 2014 Jul 19.

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• Heyland DK, Heyland RD, Cahill NE, Dhaliwal R, Day AG, Jiang X, Morrison S, Davies AR. Creating a culture of clinical excellence in critical care nutrition: the 2008 "Best of the Best" award. JPEN J Parenter Enteral Nutr. 2010 Nov-Dec;34(6):707-15. doi: 10.1177/0148607110361901.

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Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med. Christian Stoppe

Study Record Dates

• First Submitted: February 15, 2018
• First Posted: February 22, 2018
• Study Start: March 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: May 26, 2022

Record last verified: 2022-05

Locations

CA (1); IR (1); US (1); RU (1); DE (1)