INTERSEPT study: we still need more clarityписьмо
Аннотация: In recent issues of Critical Care, we read with concern the article by Pontes-Arruda and colleagues [1] and the fi rst author’s reply to the letter from Machado (the latter two of which appear in [2]). Th e article and subsequent letters address eicosapentaenoic acid/gamma-linolenic acid (EPA/GLA) use in sepsis patients in the INTERSEPT (Investigating Nutritional Th erapy with EPA, GLA and Antioxidants Role in Sepsis Treatment) study. We served as the principal investigators of this trial and come from sites that did not successfully include any patients or that included only a small number of patients. From this vantage point, we believe that Pontes-Arruda’s reply to Machado’s comments [2] did not clarify several important points. As stated in the article [1], only fi ve of the 12 sites successfully enrolled patients. However, the fi rst author’s site was responsible for the inclusion of about 100 of the 106 patients. We believe that this imbalance is relevant and that readers of Critical Care need to be aware of it. We disagree with Pontes-Arruda’s response [2] that all relevant limitations were already mentioned in the Discussion [1]. We found it diffi cult to understand his affi rmation that the results were unaff ected by the unbalanced distribution pattern of the patients, as any statistical analysis of the few patients from the other four sites would obviously be under powered. We also think he should clearly state the strategies that were used at his site to successfully enroll patients given that the 11 other sites, most of which are very skilled at performing intervention studies, failed to enroll similar numbers of patients. Th e author’s explanation [2] of the Sequential Organ Failure Assessment (SOFA) fi ndings is also not clear. We agree that it is perfectly possible for some patients to have a high SOFA score that may be insuffi cient to fulfi ll the inclusion criteria. However, the median and inter quartile values shown in Table 3 [1] indicate that 75% of all patients had a SOFA score of more than 4. Th is would be a very unusual fi nding in sepsis patients without signifi cant organ dysfunction. Moreover, the interquartile interval in Table 3 indicates that at least 75% of the patients had platelet levels of more than 144 × 10 9 cells per liter, a bilirubin level of less than 1.5 mg/dL, and a creatinine level of less than 1.6 mg/dL; as stated in the text [1], no patients had an arterial partial pressure of oxygen/ fraction of inspired oxygen (PaO 2 /FiO 2 ) ratio of less than 300. Th e high median and inter quartile values for the SOFA scores would be possible only in the presence of severe neurological or hemo dynamic dys func tion in the majority of the patients; this point, there fore, requires further explanation. Moreover, at least 50% of the patients had lactate levels of higher than 3.7 mmol/L, and this suggests that many patients already had signs of hypoperfusion (that is, severe sepsis) at inclusion. We believe that this paper needs more clarity as all of the above aspects are relevant for readers of Critical Care.
Год издания: 2012
Авторы: Flávia Ribeiro Machado, Milton Caldeira-Filho, Rubens Costa Filho, Ciro Leite Mendes, Suzana M. Lobo, Eduardo da Rocha, Jose Telles, Glauco Adrieno Westphal
Издательство: BioMed Central
Источник: Critical Care
Ключевые слова: Fatty Acid Research and Health, Clinical Nutrition and Gastroenterology, Renal function and acid-base balance
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Том: 16
Выпуск: 2
Страницы: 416–416