Enteral versus Parenteral Nutritional Support following Laparotomy for Trauma: A Randomized Prospective Trial

Adams, Susan; Dellinger, E. Patchen; Wertz, Margaret J.; Oreskovich, Michael R.; Simonowitz, David; Johansen, Kaj

doi:10.1097/00005373-198610000-00004

Cited by 193 publications

(50 citation statements)

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“…No problems 280 (61) 287 (61) Slight problems 87 (19) 71 (15) Moderate problems 60 (13) 71 (15) Severe problems 20 (4) 24 (5) Extreme problems 20 (4) 20 (4)…”

Section: Results: Cost-effectivenessmentioning

confidence: 99%

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A multicentre, randomised controlled trial comparing the clinical effectiveness and cost-effectiveness of early nutritional support via the parenteral versus the enteral route in critically ill patients (CALORIES)

Harvey

Parrott

Harrison

et al. 2016

Health Technol Assess

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BackgroundMalnutrition is a common problem in critically ill patients in UK NHS critical care units. Early nutritional support is therefore recommended to address deficiencies in nutritional state and related disorders in metabolism. However, evidence is conflicting regarding the optimum route (parenteral or enteral) of delivery.ObjectivesTo estimate the effect of early nutritional support via the parenteral route compared with the enteral route on mortality at 30 days and on incremental cost-effectiveness at 1 year. Secondary objectives were to compare the route of early nutritional support on duration of organ support; infectious and non-infectious complications; critical care unit and acute hospital length of stay; all-cause mortality at critical care unit and acute hospital discharge, at 90 days and 1 year; survival to 90 days and 1 year; nutritional and health-related quality of life, resource use and costs at 90 days and 1 year; and estimated lifetime incremental cost-effectiveness.DesignA pragmatic, open, multicentre, parallel-group randomised controlled trial with an integrated economic evaluation.SettingAdult general critical care units in 33 NHS hospitals in England.Participants2400 eligible patients.InterventionsFive days of early nutritional support delivered via the parenteral (n = 1200) and enteral (n = 1200) route.Main outcome measuresAll-cause mortality at 30 days after randomisation and incremental net benefit (INB) (at £20,000 per quality-adjusted life-year) at 1 year.ResultsBy 30 days, 393 of 1188 (33.1%) patients assigned to receive early nutritional support via the parenteral route and 409 of 1195 (34.2%) assigned to the enteral route had died [p = 0.57; absolute risk reduction 1.15%, 95% confidence interval (CI) −2.65 to 4.94; relative risk 0.97 (0.86 to 1.08)]. At 1 year, INB for the parenteral route compared with the enteral route was negative at −£1320 (95% CI −£3709 to £1069). The probability that early nutritional support via the parenteral route is more cost-effective – given the data – is < 20%. The proportion of patients in the parenteral group who experienced episodes of hypoglycaemia (p = 0.006) and of vomiting (p < 0.001) was significantly lower than in the enteral group. There were no significant differences in the 15 other secondary outcomes and no significant interactions with pre-specified subgroups.LimitationsBlinding of nutritional support was deemed to be impractical and, although the primary outcome was objective, some secondary outcomes, although defined and objectively assessed, may have been more vulnerable to observer bias.ConclusionsThere was no significant difference in all-cause mortality at 30 days for early nutritional support via the parenteral route compared with the enteral route among adults admitted to critical care units in England. On average, costs were higher for the parenteral route, which, combined with similar survival and quality of life, resulted in negative INBs at 1 year.Future workNutritional support is a complex combination of timing, dose, duration, delivery and type, all of which may affect outcomes and costs. Conflicting evidence remains regarding optimum provision to critically ill patients. There is a need to utilise rigorous consensus methods to establish future priorities for basic and clinical research in this area.Trial registrationCurrent Controlled Trials ISRCTN17386141.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 28. See the NIHR Journals Library website for further project information.

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“…No problems 280 (61) 287 (61) Slight problems 87 (19) 71 (15) Moderate problems 60 (13) 71 (15) Severe problems 20 (4) 24 (5) Extreme problems 20 (4) 20 (4)…”

Section: Results: Cost-effectivenessmentioning

confidence: 99%

“…Adams et al 15 Borzotta et al 16 Cerra et al 17 Dunham et al 18 Gianotti et al 19 Hadfield et al 14 Kalfarentzos et al 20 Kudsk et al 21 Radrizzani et al 12 Rapp et al 22 Reynolds et al 23 Woodcock et al 24 Rayes et al 25 Overall Gianotti et al 19 Kalfarentzos et al 20 Radrizzani et al 12 Rayes et al 25 Overall …”

Section: Primarymentioning

confidence: 99%

A multicentre, randomised controlled trial comparing the clinical effectiveness and cost-effectiveness of early nutritional support via the parenteral versus the enteral route in critically ill patients (CALORIES)

Harvey

Parrott

Harrison

et al. 2016

Health Technol Assess

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“…Because EN and PN are associated with risks and benefits (77,78) Advantages associated with enteral rather than parenteral nutrition include:…”

Section: Nutritionmentioning

confidence: 99%

Intensive Care Management of the Traumatic Brain Injury

Tülin¹,

Nihan²

2012

Emergency Medicine - An International Perspective

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“…68 ) In fact, the title of one of these papers was:`Early enteral feeding, compared with parenteral, reduces post-operative septic complications'. 67 In these trials, patients undergoing exploratory laparotomy for trauma were randomized to having a needle-catheter jejunostomy placed and having enteral feedings begun immediately post-operatively, or receiving PNS in that same time period.…”

Section: ±67mentioning

confidence: 99%

Nutritional support

Ofman

Koretz

1997

Aliment Pharmacol Ther

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Nutritional support currently accounts for about 1% of the total health care costs in the USA. Interestingly, most of the prospective randomized controlled trials to date have not been able to demonstrate that this therapeutic intervention alters morbidity or mortality. In fact, parenteral nutritional support may predispose the recipients to developing systemic infections. There have been a few areas in which nutritional support may be of benefit. Enteral supplements given to underweight women who suffer hip fractures reduce the hospital stay and, presumably, overall cost. Preoper‐ative parenteral nutritional support may produce a small absolute reduction in post‐operative morbidity, but its cost becomes prohibitive. Preoperative enteral nutritional support, especially if carried out in the home, may be of benefit (using the most optimistic interpretation of a small number of trials); if so, it is an economically defensible intervention. Particular nutrients or diets may have specific effects on certain disease processes. Indirect comparisons have suggested that elemental diets can be used to treat flares of Crohn's disease (perhaps because putative food antigens are removed). However, corticosteroid therapy is more efficacious. Furthermore, it is less expensive to employ 6‐mercaptopurine as the next modality in steroid failures. Branched‐chain amino acid infusions may have some effect on hepatic encephalopathy, but again, lactulose is less expensive. Nutritional support is one area of medicine in which there has been far more enthusiasm than the data justify. Disease‐associated malnutrition probably is a secondary phenomenon, not an important cause of morbidity. The widespread use of this modality cannot be justified in a cost‐constrained health care system.

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Enteral versus Parenteral Nutritional Support following Laparotomy for Trauma: A Randomized Prospective Trial

Cited by 193 publications

References 0 publications

A multicentre, randomised controlled trial comparing the clinical effectiveness and cost-effectiveness of early nutritional support via the parenteral versus the enteral route in critically ill patients (CALORIES)

A multicentre, randomised controlled trial comparing the clinical effectiveness and cost-effectiveness of early nutritional support via the parenteral versus the enteral route in critically ill patients (CALORIES)

Intensive Care Management of the Traumatic Brain Injury

Nutritional support

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