IMPACT^® Formulas Clinical Study Reference

Preoperative

Moore J, Scoggins CR, Philips P, Egger M, Tennant P et al.

Implementation of prehabilitation for major abdominal surgery and head and neck surgery: a simplified seven-day protocol.

J Gastrointest Surg 2021;25(8):2076-2082.

Prospective study in abdominal and head & neck surgery patients assessed compliance to a 7-day prehabilitation protocol added to an existing Enhanced Recovery Program (ERP). The dietitian provided patients (n=76) with education and supplies including immunonutrition [IMPACT Advanced Recovery® (IM)], incentive spirometer (IS), chlorhexidine cleanser (CC) and a pedometer. Compliance with IM was 89.5%, IS 85% and CC 92%, however only 22% of the group met the steps/day goal. Compared with propensity score matched controls (n=70), prehab patients had less pulmonary morbidity (18% vs. 48%, p=0.01) and improved post-op mobility (78% vs. 33%, p=0.02). No significant difference was found in overall infectious complications (prehab 18% vs 27%), surgical site infections (prehab 14% vs 22%), length of stay (median 6 days), or readmissions (prehab 18% vs 22%). Adding a simplified multimodal prehabilitation program to the ERP was successful for a range of surgical patients. Adherence to preop ambulation was a challenge, but good compliance to other prehab elements was associated with short-term hospital benefits.

Preoperative

Kelley KE, Fajardo AD, Strange N, Harmon CA, Pawlecki K, Sieber M, Walke N, Fadel WF, Wooden WA, et al.

Impact of a novel preoperative patient-centered surgical wellness program.

Ann Surg 2018; 268(4): 650-656.

A large retrospective review to measure the effect of a preoperative supply kit on hospital acquired infections (HAI). Major elective surgery patients (n=12,396) were educated in preadmission testing (PAT) to kit contents: chlorhexidine, mupirocin, spirometer, immunonutrition (IMPACT Advanced Recovery® Drink) and smoking cessation information. Administration covered kit costs, including a roller bag transport. Study group patients with documented compliance (n=6538) were compared with a control group (n=9202) attending PAT before kit introduction. Top service lines were general surgery, neurosurgery, orthopedics, urology, thoracic and cardiovascular surgery. Compliance reported was mupirocin (80%), immunonutrition (72%), chlorhexidine (71%) and spirometer (67%). Average compliance to all elements was 62.3%. Surgical site infection (SSI), catheter associated urinary tract infection (CAUTI), Clostridium difficile infection (CDI) and Patient Safety Indicators (PSI) were significantly reduced in the study group. Specifically, SSI rates for colectomy and hysterectomy went from 9.4 to 4.9 per 100 cases. Total compliance to kit elements lowered the risk of expected HAI by 50% (RR=0.50, p=0.003). Providing a preoperative patient supply kit and education yielded significant reductions in HAIs. Cost of kits ($323,631) was recovered in addition to $1,023,000 projected in further savings.

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Perioperative

Hamilton-Reeves JM, Bechtel MD, Hand LK, Schleper A, Yankee TM, Chalise P, Lee EK, Mirza M, Wyre H, Griffin J and Holzbeierlein JM.

Effects of immunonutrition for cystectomy on immune response and infection rates: A pilot randomized controlled clinical trial.

Eur Urol 2016;69(3):389-392.

A pilot randomized controlled clinical trial to compare immune response and post-operative complications between a group of bladder cancer surgery patients (n=29) that received perioperative immunonutrition (IMPACT Advanced Recovery® Drink) vs. a group that received isocaloric perioperative oral nutrition supplement (ONS). The immunonutrition and control groups had myeloid derived suppressor cell (MDSC) counts that were significantly different over time (p=0.005) and significantly lower in the immunonutrition group 2 days after surgery (p<0.001). Neutrophil:lymphocyte ratio was lower in the immunonutrition group vs ONS 3 hours after the first incision (p=0.039). Although not powered to detect outcome differences, the IMPACT Advanced Recovery® group had a 33% reduction in postop complication rate (p=0.060) and a 39% reduction in infection rate (p=0.027) during late phase recovery.

Preoperative

Bertrand J, Siegler N, Murez T, Poinas G, Segui B, Ayuso D, Gres P, Wagner L, Thuret R, Costa P, Droupy S.

Impact of preoperative immunonutrition on morbidity following cystectomy for bladder cancer: A case-control pilot study.

World J Urol 2014;32:233-237.

A prospective, multicenter, case-controlled pilot study to compare the rate of postoperative complications in patients with bladder cancer (n=60) who received preoperative immunonutrition (Oral IMPACT®*) with those that did not prior to cystectomy. The immunonutrition group had a lower incidence of post-operative complications (40% vs. 77%; p=0.008) including paralytic ileus and infections than the control group. Mortality, pulmonary embolism, anastomotic fistula and wound dehiscence were similar between groups.

*IMPACT Advanced Recovery® Immunonutrition Drink is the oral form of IMPACT® formula offered in the United States.

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Preoperative

Iwase H, Kariyazono H, Arima J, Yamamoto H, Nakamura K.

Nutritional effect of oral supplement enriched in ω-3 fatty acids, arginine, RNA on immune response and leukocyte–platelet aggregate formation in patients undergoing cardiac surgery.

Nutr Met Ins 2014;7:39-46.

RCT completed to investigate if preoperative use of immunonutrition (Oral IMPACT®) vs. no supplementation would influence immune response and leukocyte platelet formation in patients (n=14) having cardiac surgery. HLA–DR expression, CD4/CD8 ratio and the production of IFN–γ by CD4–positive cells were increased in the immunonutrition group (p<0.05). Conversely, IL 10 level and the formation of leukocyte-platelet aggregates before and after surgery were suppressed to a greater extent in the immunonutrition group (p<0.05). These effects may decrease the incidence of complications after surgery.

Preoperative

Tepaske R, Velthuis HT, Oudemans-Van Straaten HM, Bossuyt PMM, Schultz JM, Eijsman L, Vroom M.

Glycine does not add to the beneficial effects of perioperative oral immune-enhancing nutrition supplements in high-risk cardiac surgery patients.

JPEN 2007; 31(3): 173-180.

A prospective, randomized study to measure outcomes from the addition of glycine to an oral immune-enhancing nutrition supplement (Oral IMPACT®+ glycine) as compared to a standard oral immune-enhancing nutrition supplement (Oral IMPACT®) and a control group receiving standard nutrition. Each nutrition supplement was administered for a minimum of 5 preoperative days. Patients (n=70) were 70+ years of age, had compromised left ventricular function or the need for mitral valve surgery. Outcomes of morbidity, organ function and postoperative recovery were analyzed. In both groups receiving the Oral IMPACT® formula, infectious morbidity was decreased (23%/17% vs. 50%) as compared to the control (p=0.02). Conclusions of the study were that use of preoperative Oral IMPACT® formula reduces the rate of infectious morbidity and results in more hemodynamic stability. The addition of glycine did not result in any additional benefit.

Preoperative

Kavanaugh E, Bilbo A, Martin K.

Enhanced recovery after surgery: does the provision of immune-modulating protein supplements improve post-operative outcomes?

Presented at ERAS-USA, New Orleans, November 2018.

A cross-sectional, retrospective study of gastrointestinal surgery (GI) patients that compared grant-funded (GF; n=120) and self-pay (SP; n=120) cohorts. Both groups received Enhanced Recovery Protocols (ERPs), and both were instructed to drink IMPACT Advanced Recovery® prophylactically (3 cartons/day for 5 days). 83% of the GF cohort reported drinking ≥ 2/3 of the prescribed regimen, with 71.6% reporting perfect compliance. Mean and standard deviation of length of stay (LOS) in the GF group vs. SP group was 6.37±5.5 days vs. 8.30±7.9 days (p=0.03), respectively. The incidence of 30-day readmission and SSI also trended lower. GI surgery patients provided IMPACT Advanced Recovery® Drink preoperatively as part of an ERP, and at no charge, had a significantly reduced LOS when compared to ERP patients purchasing the product out-of-pocket.

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Preoperative

Aida T, Furukawa K, Suzuki D, Shimizu H, Yoshidome H, Ohtsuka M, Kato A, Yoshitomi H, Miyazaki M.

Preoperative immunonutrition decreased postoperative complications by modulating prostaglandin E2 production and T-cell differentiation in patients undergoing pancreatoduodenectomy.

Surg 2014;155:124-133.

RCT to investigate the effect of preoperative immunonutrition (Oral IMPACT®) vs. early postop standard tube feeding on postop complications and immune response in patients having pancreatoduodenectomy (n=50). Infectious complications in the immunonutrition group were significantly lower than in the control group (28% vs. 60%, p<0.05), and the severity of complications were also lower (p<0.05). EPA, EPA:AA were higher and PGE2 levels lower in the immunonutrition vs control group (p<0.05). This preoperative modulation was associated with higher levels of T-Bet vs. GATA3 mRNA expression (p<0.05), showing favorable Th1/Th2 differentiation in the ORAL IMPACT® group. This demonstrates a decrease in stress-induced immunosuppression.

Postoperative

Marano L, Profidia R, Pezzella M, Grassia M, Petrillo M et al.

Clinical and immunological impact of early postoperative enteral immunonutrition after total gastrectomy in gastric cancer patients: A prospective randomized study.

Ann Surg Oncol 2013; 2012:3912-3918.

Randomized controlled trial done to investigate the effect of early post-op immunonutrition on outcomes in gastric cancer patients undergoing gastrectomy (n=109). Post-operative feedings were administered 6 hours post-op via jejunal tube and continued until post-op day 7. Formulas were isonitrogenous and isocaloric, however the study group tube feeding contained supplemental L-arginine, n-3 fatty acids and nucleotides (IMPACT®) and the control group received standard formula. Infectious complications in the study group were significantly lower than in the control group (7.4% vs. 20%, p<0.05), as was the rate of anastomotic leak (3.7% vs 7.3%, p<0.05). LOS for the intervention group was 3.2 days less than for the control group (p=0.029).

Preoperative

Okamoto Y, Okano K, Izuishi K, Usuki H, Wakabayashi H, Suzuki Y.

Attenuation of the systemic inflammatory response and infectious complications after gastrectomy with preoperative oral arginine and omega-3 fatty acids supplemented immunonutrition.

World J Surg 2009;33:1815-1821.

RCT designed to evaluate the effect of preoperative oral immunonutrition (Oral IMPACT®) vs. postop isocaloric TPN on cellular immunity, duration of SIRS and postoperative complications after upper GI cancer surgery (n=60). Post-operative infectious complications in the intervention group were significantly lower than in the control group (6% vs. 28%, p<0.05), as was the duration of SIRS (0.77 vs. 1.34 days, p<0.05). Postoperative lymphocyte and CD4+T-cell counts decreased in both groups (p<0.05), however the CD4+T-cell counts on preop day 1 and post-op day 7 were higher in the interventional than control group (p<0.05).

Postoperative

Farreras N, Artigas V, Cardona D, Rius X, Trias M, Gonzalez JA.

Effect of early postoperative enteral immunonutrition on wound management in patients undergoing surgery for gastric cancer.

Clin Nutr 2005; 24: 55-65.

A prospective, randomized study to determine the effect of early postoperative enteral immunonutrition (IMPACT® formula) on wound management in patients undergoing surgery for gastric cancer. Sixty-six patients were randomized to receive IMPACT® formula or an isocaloric, isonitrogenous control formula. The wound management process was analyzed, as well as, development of surgical wound management complications in sixty patients. Those patients who received IMPACT® formula had significantly increased hydroxyproline levels (p=0.0018) and decreased incidence of wound management complications (p=0.005). Authors concluded that early provision of IMPACT® formula postoperatively improves wound management substrates and decreases wound complications.

Preoperative + Perioperative

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.

A prospective, randomized, controlled trial of 200 patients with colorectal neoplasm requiring surgical resection. The 4 groups were randomized to: Group 1, perioperative supplementation with Oral IMPACT® formula for 5 days preoperatively and IMPACT® tube feeding postoperatively; Group 2, preoperative Oral IMPACT® for 5 days; Group 3 (control), isonitrogenous/caloric oral supplement preoperatively for 5 days; and Group 4; no supplementation before or after surgery (conventional therapy). Immune response (p<0.05), gut oxygenation (p<0.01) and microperfusion (p<0.02) were found to be significantly better for Groups 1 and 2. Overall, Groups 1 and 2 fed IMPACT® formula both perioperatively and preoperatively had outcomes of decreased infectious complications (p<0.02 p<0.04); reductions in antibiotic therapy days (p<0.005, p<0.004) and length of hospital stay (p<0.0005), as compared to the control and conventional therapy groups.

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Postoperative

Chapman JS, Roddy E, Westhoff G, Simons E, Brooks R, Ueda S, Chen L.

Post-operative enteral immunonutrition for gynecologic oncology patients undergoing laparotomy decreased wound complications.

Gyn Onc 2015; 137:523-528.

Retrospective cohort study of postoperative immunonutrition (IMPACT Advanced Recovery® Drink) and no supplementation as a quality practice improvement for patients having laparotomy for gynecological malignancy (n=338). 75% patient compliance to postop intervention was noted. Fewer wound complications were observed in patients receiving immunonutrition (19.6% vs 33%; p=0.049). After controlling for variables associated with development of wound complications, patients receiving immunonutrition had a 78% reduction in CDC SSI class 2 and 3 infections (OR = 0.22, CI 0.05-0.95, p=0.044) in comparison to control.

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Perioperative

Celik JB, Gezginc K, Ozcelik K, Celik C.

The role of immunonutrition in gynecologic oncologic surgery.

Eur J Gynaecol Oncol 2009;30: 418-421.

RCT of perioperative immunonutrition (IMPACT®) and perioperative isocaloric standard formula in patients operated on with gynecological malignancies (n=50). WBC count, lymphocyte population and CRP levels were significantly higher in the intervention group (p<0.05). Post-op pulmonary and urinary infection rates were similar in both groups, but wound infection rate (4% vs 20%) and LOS (Δ 3.7 days) were significantly lower in the treatment group (p<0.05).

Preoperative

Mueller SA, Mayer C, Bojaxhiu B, Aeberhard C, Schuetz P et al.

Effect of preoperative immunonutrition on complications after salvage surgery in head and neck cancer.

Journal of Otolaryngology – Head and Neck Surgery 2019;48(25):1-9.

Single-armed study with historical control evaluated preoperative immunonutrition (IM) on postoperative complications in high-risk patients (n=96) having salvage surgery for head and neck squamous cell carcinoma (HNSCC) recurrent to radiation therapy (RT), chemo-radiotherapy (CRT) or RT with immunotherapy. Study patients (n=51) received IM (Oral IMPACT®), three units per day for 5 days before surgery. A multivariate regression model accounted for differences in clinical characteristics when measuring study endpoints. 84.3% of study patients consumed ≥75% of the IM prescribed. The rate of any complication within 30 days after surgery was lower in the IM group (35% vs. 58%, p=0.027), and adjusted to OR 0.28, p=0.049).

All subcategories of complications (wound dehiscence, wound abscess, fistula and hematoma/seroma) were also decreased for the IM group, but not statistically significant. Despite readmissions being similar, the IM group had a significantly shorter median LOS (6 vs. 17 days) which adjusted to an 11.36 day difference (p≤0.001). LOS results may have been partially biased due to reimbursement changes. Regardless, preoperative IM may be of particular benefit in the high-risk HNSCC population because of effects on tissue regeneration and immune response.

Perioperative

Rowan NR, Johnson JT, Fratangelo CE, Smith BK, Kemerer PA, Ferris RL.

Utility of a perioperative nutrition intervention on postoperative outcomes in high-risk head and neck cancer patients.

Oral Onc 2016;54:42-46.

Identify outcomes associated with implementing perioperative immunonutrition (IMPACT Advanced Recovery® Drink and IMPACT® Peptide 1.5 formula) vs. postop standard formula as part of a quality practice improvement (QPI) initiative with high-risk head and neck cancer surgical patients (n=195). 25.2% of the immunonutrition patients registered complications vs 47.5% in the standard of care group (p=0.0021). Pharyngeal leaks or fistulas were the most common complication in both groups, and more common in patients not receiving supplementation (p=0.007). Mean LOS was reduced by 2.8 days in those receiving immunonutrition (p=0.02). Readmission rates between the two groups were similar.

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Preoperative

Ochoa JB*, Lessar ST and Glembot TM.

Preoperative immunonutrition in elective orthopedic and bariatric surgery: Clinical outcomes with patient compliance.

Presented at the American Society of Enhanced Recovery (ASER), April 2021.

Prospective study that examined outcomes among adult orthopedic total hip and knee (n=3,409) and bariatric (n=907) surgical patients in relation to patient compliance to an oral immunonutrition (IM) supplement (IMPACT Advanced Recovery®). During a preoperative visit and class, patients were instructed to consume 1 carton of IM three times a day for five days prior to surgery. IM was provided free of charge and consumption recorded in the EMR. Compliance was defined as none, partial (1-11 cartons) and full (12-15 cartons). 77% of orthopedic patients achieved full compliance as did 86% of bariatric patients. A decrease in orthopedic length of stay (LOS) was observed in relation to full vs. partial vs. no compliance (2.68, 2.71 and 3.25 days, respectively; p≤0.01). A decrease in bariatric LOS was also observed, but did not reach statistical significance (2.20, 2.07 and 2.42 days, respectively; p=0.497). A high rate of compliance to the IM supplement was observed, supported by patient education and access. Dose dependent reductions in LOS support the use of preoperative IM in these populations.

*Employee of Nestlé Health Science at the time the study grant was funded by Nestlé HealthCare Nutrition, Inc.

Preoperative

Heynen K.

Pre-op Nutrition: Making an IMPACT.

Presented at American Society of Enhanced Recovery (ASER), Fort Lauderdale, March 2018.

A retrospective analysis of total joint patients, having surgery for replacement of a hip, shoulder or knee, to evaluate differences in outcomes dependent on a preoperative immunonutrition protocol. The intervention group (n=77) received education about the protocol during a preoperative class, and was directed to consume 3 cartons of IMPACT Advanced Recovery® Drink per day for 5 days prior to surgery. A control group of equal size (n=77) did not receive the supplement, and was matched for type of joint replacement, surgeon, American Society of Anesthesiology (ASA) score and age.

Although study numbers were too small to calculate statistical significance, the readmission, surgical site infection and readmission rates were all lower for the intervention group vs. the control group at 90 days. Specifically, the readmission rate was 10.39% for the intervention group as compared with 12.99% for the control.

Perioperative

Robinson LA, Tanvetyanon T, Grubbs D, Robinson NA, Pierce CM et al.

Preop nutrition-enhanced recovery after surgery protocol for thoracic neoplasms.

J Thorac Cardiovasc Surg 2021;162(3):710-720.

The outcomes from a preoperative nutritional support program (N-ERAS©) for thoracic neoplasm (mostly lung) surgery patients (n=229, normally nourished) were compared retrospectively to a historical standard of care control (n=233, normally nourished) over a period of two years. The preoperative protocol consisted of: IMPACT Advanced Recovery® Drink (IM), consumed three times a day for five days preoperatively, 1-2 doses of a carbohydrate loading beverage, and daily multispecies probiotics starting at the preoperative clinic visit and continuing postoperatively. IM also continued during hospitalization. Patient compliance to the protocol approached 100%, with patients feeling empowered. Favorable associated reductions include lower complications (49.2%; p=0.001), time to recover bowel function (15.4%; p<0.001), hospital stay (13.6%; p=0.001) and hospital cost (16.1%; p=0.001). The hospital projected a savings of $503,342. Further, multivariable analysis found use of N-ERAS© independently predicted the absence of complications (OR 0.46; 95% CI, 0.26-0.79; p=0.005). Consideration to use N-ERAS© in thoracic cancer surgery is appropriate to general thoracic surgeons using any technical approach.

©2010 H. Lee Moffitt Cancer Center and Research Institute, Inc.

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Preoperative

Kaya SO, Akcam TI, Ceylan KC, Samancılar O, Ozturk O, Usluer O.

Is preoperative protein-rich nutrition effective on postoperative outcome in non-small cell lung cancer surgery? A prospective randomized study.

J Cardiothor Surg 2016;11:14.

Prospective, randomized study to evaluate the benefit of a 10 day course of preoperative immunonutrition (ORAL IMPACT®) vs. normal diet in well-nourished patients having anatomic resection for non-small cell lung cancer (n=58). Patients in the immunonutrition group reported fewer complications vs. the control group (19.4% vs. 44.4%; p=0.049). Study patients also reported a reduced chest tube drainage time vs. the control group, on average (4 days vs. 6 days; p=0.019).