Trial reportIntensive care medicine2003
Early enteral immunonutrition in patients with severe sepsis: results of an interim analysis of a randomized multicentre clinical trial.
Trial report in Intensive care medicine, 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 90 papers, 14 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
90 citing papers in PubMed, 14 syntheses or guidelines pooled it, 329 citations in OpenAlex.
- Comparison of the effects of different models of nutrient supply on nutritional status and clinical outcomes in ICU patients: a systematic review and network meta-analysis.European journal of clinical nutrition · 2026Pooled it
- Effects of enteral immunonutrition enriched with multiple immunonutrients on clinical outcomes of patients who underwent gastric cancer surgery: a systematic review and meta-analysis.Frontiers in medicine · 2026Pooled it
- Influence of early enteral nutrition on mortality of adult patients with sepsis: a meta-analysis of randomized controlled trials.European journal of medical research · 2025Pooled it
- Strategies to Maximize the Benefits of Evidence-Based Enteral Nutrition: A Narrative Review.Nutrients · 2025Pooled it
- Comparison of Early Enteral Nutrition Versus Early Parenteral Nutrition in Critically Ill Patients: A Systematic Review and Meta-Analysis.Nutrients · 2024Pooled it
- Surviving sepsis campaign international guidelines for the management of septic shock and sepsis-associated organ dysfunction in children.Intensive care medicine · 2020Guideline
- Enteral versus parenteral nutrition and enteral versus a combination of enteral and parenteral nutrition for adults in the intensive care unit.The Cochrane database of systematic reviews · 2018Pooled it
- Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016.Intensive care medicine · 2017Guideline
- Effects of omega-3 fatty acid nutrition on mortality in septic patients: a meta-analysis of randomized controlled trials.BMC anesthesiology · 2016Pooled it
- Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock, 2012.Intensive care medicine · 2013Guideline
- Prevention, diagnosis, therapy and follow-up care of sepsis: 1st revision of S-2k guidelines of the German Sepsis Society (Deutsche Sepsis-Gesellschaft e.V. (DSG)) and the German Interdisciplinary Association of Intensive Care and Emergency Medicine (Deutsche Interdisziplinäre Vereinigung für Intensiv- und Notfallmedizin (DIVI)).German medical science : GMS e-journal · 2010Guideline
- Guideline
- [Diagnosis and therapy of sepsis. Guidelines of the German Sepsis Society Inc. and the German Interdisciplinary Society for Intensive and Emergency Medicine].Der Internist · 2006Guideline
- Parenteral vs. enteral nutrition in the critically ill patient: a meta-analysis of trials using the intention to treat principle.Intensive care medicine · 2005Pooled it
- Enteral citrulline supplementation versus placebo on SOFA score on day 7 in mechanically ventilated critically ill patients: the IMMUNOCITRE randomized clinical trial.Critical care (London, England) · 2023Trial
- Effect of nutritional support in patients with lower respiratory tract infection: Secondary analysis of a randomized clinical trial.Clinical nutrition (Edinburgh, Scotland) · 2021Trial
- Urinary Titin N-Fragment Evaluation in a Randomized Controlled Trial of Beta-Hydroxy-Beta-Methylbutyrate for Acute Mild Trauma in Older Adults.Nutrients · 2021Trial
- Arginine administration to critically ill patients with a low nitric oxide fraction in the airways: a pilot study.Intensive care medicine · 2013Trial
- Randomized clinical trial of the effects of perioperative use of immune-enhancing enteral formula on metabolic and immunological status in patients undergoing esophagectomy.World journal of surgery · 2007Trial
- Early enteral immunonutrition vs. parenteral nutrition in critically ill patients without severe sepsis: a randomized clinical trial.Intensive care medicine · 2006Trial
30 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
8 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo compare the mortality of critically ill patients given either enteral feeding with an immune-enhancing formula or parenteral nutrition (PN). We report the results of a planned interim analysis on patients with severe sepsis which was undertaken earlier than planned once a meta-analysis suggested excess mortality in patients with severe sepsis given enteral immunonutrition.
designRandomised multicentre unblinded controlled clinical trial.
settingThirty-three General Intensive Care Units in Italy. PATIENTS AND
participantsAmong the 237 recruited patients, 39 had severe sepsis or septic shock; 21 of them received PN.
interventionsEligible patients received either total PN or enteral nutrition, the latter containing extra L-arginine, omega-3 fatty acids, vitamin E, beta carotene, zinc, and selenium. MEASUREMENTS AND
resultsThe primary endpoint for the subgroup analysis on patients with severe sepsis was mortality on Intensive Care Unit (ICU). The ICU mortality of patients with severe sepsis given enteral nutrition (EN) was higher than for those given PN (44.4% vs 14.3%; p=0.039). More patients given EN than patients given PN still had severe sepsis when they died (38.9% vs 9.5%, p=0.055). Recruitment of patients with severe sepsis was subsequently stopped.
conclusionsOur results show that enteral immunonutrition, compared to PN, may be associated with excess mortality in patients with severe sepsis.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.