• Why Use IMPACT®?
• IMPACT® Details

Why use IMPACT®?

Major surgery and severe trauma are associated with major immunological and metabolic changes. These patients are extremely vulnerable to infection and are susceptible to secondary complications, such as poor wound healing. Despite significant advancements in patient care, decreased immune function puts surgical and trauma patients at a much higher risk for infection than the general hospital population.

An ever growing number of prospective randomized clinical trials demonstrate that specialized nutritional support with IMPACT® in these patient populations reduces the risk of post-operative and post-injury infections.

The use of IMPACT® is recommended for patients undergoing surgery for the following conditions and those patients with the following traumatic injuries. IMPACT® may be used for patients undergoing other surgical procedures or with other traumatic injuries as determined to be appropriate by a Healthcare Provider.

Surgery:

• Upper GI Cancer^5-7
• Gastric Cancer ^{8-12, 23}
• Pancreatic Cancer ^8-14
• Colorectal Cancer ^12,14-15
• Esophageal Cancer ^7,10
• Gastroesophageal Cancer ¹⁴
• Head and Neck Cancer ¹⁶
• Cardiovascular - CABG and Mitral Valve Replacement ¹⁷

Trauma:

• Blunt and penetrating torso trauma ¹⁸
• Patients with Injury Severity Score ≥ 18 ^18,19
• Patients with Abdominal Trauma Index ≥ 20 ¹⁸
• Patients with multiple intra-abdominal injuries ¹⁸
• Patients with Therapeutic Intervention Scoring System ≥ 20 ^{20, 21}
• Severe head injury (Glasgow Coma Scale < 8) ^18,22
• Burns = 30% total body surface area (third degree) ¹⁸

References

1. Wallace WC, Cinat M, Gornick WB, Lekawa ME, Wilson SE..Nosocomial Infections in the Surgical Intensive Care Unit: A Difference between Trauma and Surgical Patients. The American Surgeon. 1999;65(10): 987-90.
2. Weinstein RA. Nosocomial Infection Update. Emerging Infectious Diseases.1998; 4(3): 416-20.
3. Fernandez AH, Monge V, Garcinuno MA. Surgical Antibiotic Prophylaxis: Effect in Postoperative Infections. European Journal of Epidemiology. 2001;17(4): 369-74.
4. Alberti C, Brun-Buisson C, Burchardi H, Martin C, et al. Epidemiology of Sepsis and Infection in ICU Patients from an International Multicentre Cohort Study. Intensive Care Medicine. 2002;28: 108-21.
5. Senkal M, Mumme A, Eickhoff U, Geier B, Spath G, Wulfert D, et al. Early Postoperative Enteral Immunonutrition: Clinical Outcome and Cost-Comparison Analysis in Surgical Patients. Crit Care Med. 1997;25:1489-1496.
6. Daly JM et al. Enteral Nutrition with Supplemental Arginine, RNA, and Omega-3 Fatty Acids in Patients after Operation: Immunologic, Metabolic, and Clinical Outcome. Surgery 1992;112:56-67.
7. Senkal M et al. Outcome and Cost-effectiveness of Perioperative Enteral Immunonutrition in Patients Undergoing Elective Upper Gastrointestinal Tract Surgery: A Prospective Randomized Study. Arch Surg 1999;134:1309-1316.
8. Braga M, Gianotti L, Vignali A, Cestari A, Bisagni P, Di Carlo V. Artificial Nutrition after Major Abdominal Surgery: Impact® of Route of Administration and Composition of the Diet. Crit Care Med. 1998;26:24-30.
9. Gianotti L, Braga M, Vignali A, Balzano G, Zerbi A, Bisagni P, et al. Effect of Route of Delivery and Formulation of Postoperative Nutritional Support in Patients Undergoing Major Operations for Malignant Neoplasms. Arch Surg. 1997;132:1222-1230.
10. Daly JM, Weintraub FN, Shou J, Rosato EF, Lucia M. Enteral Nutrition during Multimodality Therapy in Upper Gastrointestinal Cancer Patients. Ann Surg. 1995;221:327-338.
11. Braga M, Vignali A, Gianotti L, Cestari A, Profili M, Di Carlo V. Benefits of Early Postoperative Enteral Feeding in Cancer Patients. Infusionsther Transfusionsmed 1995; 22:280-284.
12. Braga M, Gianotti L, Nespoli L, Radaelli G, Di Carlo V. Nutritional Approach in Malnourished Surgical Patients: A Prospective Randomized Study. Arch Surg.2002; 137:174-180.
13. Braga M et al. Artificial Nutrition after Major Pancreatic Resection. Results of a Prospective Randomized Clinical Trial. Journal of Parenteral and Enteral Nutrition 1999;23 (1):S2.
14. Gianotti L, Braga M, Nespoli L, Radaelli G, Beneduce A, Di Carlo V. A Randomized Controlled Trial of Preoperative Oral Supplementation with a Specialized Diet in Patients with Gastrointestinal Cancer. Gastroenterology. 2002; 122:1763-1770.
15. Braga M, Gianotti L, Vignali A, Di Carlo V. Preoperative Oral Arginine and n-3 Fatty Acid Supplementation Improves the Immunometabolic Host Response and Outcome after Colorectal Resection for Cancer. Surgery. 2002; 132:805-814.
16. Snyderman CH et al. Reduced Postoperative Infections with an Immune-Enhancing Nutritional Supplement. The Laryngoscope. 1999; 109:915-921.
17. Tepaske R, Velthuis H, Oudemans-van Straaten HM, Heisterkamp, SH, van Deventer SJ, Ince C, et al. Effect of Preoperative Oral Immune-enhancing Nutritional Supplement on Patients at High Risk of Infection after Cardiac Surgery: A Randomised Placebo-controlled Trial. Lancet. 2001;358:696-701.
18. Kudsk KA et al. Consensus Recommendations from the U.S. Summit on Immune-enhancing Enteral Therapy. Journal of Parenteral and Enteral Nutrition. 2001;25(suppl):S61-S62.
19. Weimann A, Bastian L, Bischoff WE, Grotz M, Hansel M, Lotz J, et al. Influence of Arginine, Omega-3 Fatty Acids and Nucleotide-supplemented Enteral Support on Systemic Inflammatory Response Syndrome and Multiple Organ Failure in Patients after Severe Trauma. Nutrition. 1998;14:165-172.
20. Bower RH, Cerra FB, Bershadsky B, Licari JJ, Hoyt DB, Jensen GL, et al. Early Enteral Administration of a Formula (Impact®) Supplemented with Arginine, Nucleotides, and Fish Oil in Intensive Care Unit Patients: Results of a Multicenter, Prospective, Randomized, Clinical Trial. Crit Care Med. 1995;23:436-449.
21. Oltermann MH and Rassas TN. Immunonutrition in a Multidisciplinary ICU Population: A Review of the Literature. Journal of Parenteral and Enteral Nutrition. 2001;25(suppl):S30-S35.
22. Chendrasekhar AC et al. Evaluation of an Enhanced Diet in Patients with Severe Closed Head Injury. Crit Care Med. 1997; 25(suppl):A80.
23. Farreras N et al. Effect of Early Postoperative Enteral Immunonutrition on Wound Healing in Patients Undergoing Surgery for Gastric Cancer. Clinical Nutrition. 2005;24:55-65.

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IMPACT® Details

The pre-operative use of IMPACT® has been demonstrated in clinical trials to significantly improve the outcomes of major-elective surgical patients. Well-nourished patients (less than 10% weight loss prior to surgery) who received IMPACT® for at least 5 days prior to surgery developed significantly fewer post-operative infections than those patients who received no nutritional support, which is the conventional nutrition therapy for this patient population.

Similarly, the perioperative use of IMPACT® (pre and post-surgery) has been shown to significantly improve outcomes in the appropriate major-elective surgical patient populations. Malnourished patients (more than 10% weight loss prior to surgery) who received IMPACT® for at least 5 days prior to surgery and for at least 5 days after surgery (via tube feeding) developed significantly fewer post-operative complications than patients who either received IMPACT® prior to surgery plus post-operative nutrition support with a standard formula or pre and post-operative support with a standard formula.

The post-operative or post-injury use of IMPACT® (without the pre-operative preparatory regimen) has also been shown to provide clinical benefits to patients with a high risk of developing infections and improve patient outcomes. Patients who received IMPACT® after surgery or traumatic injury experienced fewer infectious complications than those patients who received a standard enteral feeding formula.

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