A randomized controlled pilot study to evaluate the effect of an enteral formulation designed to improve gastrointestinal tolerance in the critically ill patient—the SPIRIT trial

Abstract

BackgroundDiarrhea is frequent in patients in intensive care units (ICU) and is associated with discomfort and complications and may increase the length of stay and nursing workload.MethodsThis was a prospective, double-blind, randomized, controlled single-center pilot study to assess the incidence and frequency of diarrhea and the respective effects of a modified enteral diet (intervention: Peptamen® AF, rich in proteins, medium chain triglycerides and fish oil) compared to a standard diet (control: Isosource® Energy) in 90 randomized adult patients (intervention, n = 46; control, n = 44) with an ICU stay ≥5 days and tube feeding ≥3 days. Tube feeding was initiated within 72 h of ICU admission and continued up to 10 days. The caloric goal was adjusted to needs by indirect calorimetry. Gastrointestinal function, nutritional intake, and nursing workload were recorded. Follow-up was until 28 days after randomization.ResultsMedian age was 63.3 (interquartile range (IQR) 51.0–73.2) years and Simplified Acute Physiology Score (SAPS) II was 61.0 (IQR 47.8–74). Time to reach caloric goal (intervention: 2.2 (0.8–3.7) days (median, IQR); control: 2.0 (1.3–2.7) days; p = 0.16), length of time on study nutrition (intervention: 5.0 (3.6–6.4) days; control: 7.0 (5.3–8.7) days; p = 0.26), and calorie intake (intervention: 18.0 (12.5–20.9) kcal/kg/day; control 19.7 (17.3–23.1) kcal/kg/day; p = 0.08) did not differ between groups, with a higher protein intake for Peptamen® group (1.13 (0.78–1.31) g/kg/day vs 0.80 (0.70–0.94); p < 0.001). No difference in diarrhea incidence (intervention group: 29 (64%); control group: 31 (70%); p = 0.652), use of fecal collectors (23 (51%) vs. 24 (55%); p = 0.83), or diarrhea-free days (161 (64%) vs 196 (68%); p = 0.65) was found. Nursing workload and cost for diarrhea care were not different between the groups. In a post-hoc analysis, adjusted for treatment group, age, sex, and SAPS II score, diarrhea was associated with length of mechanical ventilation (9.5 (6.0–13.1) vs. 3.9 (3.2–4.6) days; p = 0.006) and length of ICU stay (11.0 (8.9–13.1) vs. 5.0 (3.8–6.2) days; p = 0.001).ConclusionsIn this pilot study, we found a high incidence of diarrhea, which was not attenuated by Peptamen® AF. Patients with diarrhea stayed longer in the ICU.Trial registrationClinicalTrials.gov identifier, NCT01581957. Registered on 18 April 2012.Electronic supplementary materialThe online version of this article (doi:10.1186/s13054-017-1730-1) contains supplementary material, which is available to authorized users.

Systematic Review With Meta‐Analysis of Patient‐Centered Outcomes, Comparing International Guideline–Recommended Enteral Protein Delivery With Usual Care

“…Six trials were eligible for inclusion, which included 511 patients ( Figure 1, PRISMA diagram). [27][28][29][30][31][32]…”

“…For continuous variables, mean and SD were directly recorded, and median with interquartile range data were converted prior to analysis to approximate mean (SD) data as described by Wan et al 26 All included studies reported protein and energy provision in g/kg per day and kcal/kg per day; when actual weight was reported and the mean BMI was within the healthy weight range (BMI 18.5-25 kg/m 2 if ࣘ65 years old, 22-27 kg/m 2 if >65 years old), the reported mean (SD) protein dose was used in data analyses; if actual weight was reported and the mean BMI was above the healthy weight range, then calculations were done to assess the protein provision based on IBW (defined as the upper end of the healthy weight range); if studies reported IBW or an adjusted IBW for the protein dose, this was used in the data analyses. One author was contacted 27 to further assess their data to confirm that protein was provided at a level of 1.2 g/kg IBW per day in the intervention.…”

Functional ability and quality of life in critical illness survivors with intensive care unit acquired weakness: A secondary analysis of a randomised controlled trial

“…All patients were managed by targeted, light sedation and protocol-guided weaning [23]. Standard ICU care also included a nutrition protocol and regular assessments of energy expenditure using indirect calorimetry [24]. Physiotherapy started within 48 hours of ICU admission with two different exercise regimes that included usual early mobilisation versus early, progressive endurance and resistance training in addition to usual early mobilisation.…”

DGEM-Leitlinie: „Klinische Ernährung in der Intensivmedizin“

“…In der sog. Spirit-Studie führte der Einsatz einer enteralen Diät mit hydrolysiertem Protein verglichen mit einer polymeren Standardsondenkost nicht zu einer Verringerung diarrhöfreier Tage [227]. Zum Einsatz von Ballaststoffen wird auf Kap.…”