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1.
Gastrointestinal Tolerance and Protein Absorption Markers with a New Peptide Enteral Formula Compared to a Standard Intact Protein Enteral Formula in Critically Ill Patients.
de Brito-Ashurst, I, Klebach, M, Tsompanaki, E, Kaul, S, van Horssen, P, Hofman, Z
Nutrients. 2021;(7)
Abstract
The aim of this exploratory study was to investigate gastrointestinal tolerance and protein absorption markers with a new enteral peptide formula (PF) compared to an isocaloric enteral intact protein standard formula (SF) containing the same amount of protein in ICU patients. Patients admitted to a cardio-thoracic intensive care unit expected to receive tube feeding for ≥5 days were randomized to receive either PF (1.5 kcal/mL) or SF in a double-blind manner for ≤14 days. Twenty-six patients were randomized (13 SF and 13 PF) and 23 (12 SF and 11 PF) completed at least 5 days of product administration. There were no statistically significant differences between the feeds during the first 5 days of intervention for diarrhea (SF:3 (23%); PF:5 (39%), p = 0.388), vomiting (SF:1 (8%); PF:2 (15%), p = 0.549), constipation (SF:7 (54%), PF:3 (23%), p = 0.115), and high gastric residual volume (>500 mL: SF:1 (8%); PF: 2 (15%), p = 0.535). There were no differences in plasma amino acids or urinary markers of protein absorption and metabolism. In conclusion, no major differences were found in tolerability and protein absorption markers between the standard intact protein formula and the peptide formula.
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2.
Differences in mortality in critically ill elderly patients during the second COVID-19 surge in Europe.
Jung, C, Fjølner, J, Bruno, RR, Wernly, B, Artigas, A, Bollen Pinto, B, Schefold, JC, Wolff, G, Kelm, M, Beil, M, et al
Critical care (London, England). 2021;(1):344
Abstract
BACKGROUND The primary aim of this study was to assess the outcome of elderly intensive care unit (ICU) patients treated during the spring and autumn COVID-19 surges in Europe. METHODS This was a prospective European observational study (the COVIP study) in ICU patients aged 70 years and older admitted with COVID-19 disease from March to December 2020 to 159 ICUs in 14 European countries. An electronic database was used to register a number of parameters including: SOFA score, Clinical Frailty Scale, co-morbidities, usual ICU procedures and survival at 90 days. The study was registered at ClinicalTrials.gov (NCT04321265). RESULTS In total, 2625 patients were included, 1327 from the first and 1298 from the second surge. Median age was 74 and 75 years in surge 1 and 2, respectively. SOFA score was higher in the first surge (median 6 versus 5, p < 0.0001). The PaO2/FiO2 ratio at admission was higher during surge 1, and more patients received invasive mechanical ventilation (78% versus 68%, p < 0.0001). During the first 15 days of treatment, survival was similar during the first and the second surge. Survival was lower in the second surge after day 15 and differed after 30 days (57% vs 50%) as well as after 90 days (51% vs 40%). CONCLUSION An unexpected, but significant, decrease in 30-day and 90-day survival was observed during the second surge in our cohort of elderly ICU patients. The reason for this is unclear. Our main concern is whether the widespread changes in practice and treatment of COVID-19 between the two surges have contributed to this increased mortality in elderly patients. Further studies are urgently warranted to provide more evidence for current practice in elderly patients. TRIAL REGISTRATION NUMBER NCT04321265 , registered March 19th, 2020.
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Development of the Gastrointestinal Dysfunction Score (GIDS) for critically ill patients - A prospective multicenter observational study (iSOFA study).
Reintam Blaser, A, Padar, M, Mändul, M, Elke, G, Engel, C, Fischer, K, Giabicani, M, Gold, T, Hess, B, Hiesmayr, M, et al
Clinical nutrition (Edinburgh, Scotland). 2021;(8):4932-4940
Abstract
BACKGROUND & AIMS To develop a five grade score (0-4 points) for the assessment of gastrointestinal (GI) dysfunction in adult critically ill patients. METHODS This prospective multicenter observational study enrolled consecutive adult patients admitted to 11 intensive care units in nine countries. At all sites, daily clinical data with emphasis on GI clinical symptoms were collected and intra-abdominal pressure measured. In five out of 11 sites, the biomarkers citrulline and intestinal fatty acid-binding protein (I-FABP) were measured additionally. Cox models with time-dependent scores were used to analyze associations with 28- and 90-day mortality. The models were estimated with stratification for study center. RESULTS We included 540 patients (224 with biomarker measurements) with median age of 65 years (range 18-94), the Simplified Acute Physiology Score II score of 38 (interquartile range 26-53) points, and Sequential Organ Failure Assessment (SOFA) score of 6 (interquartile range 3-9) points at admission. Median ICU length of stay was 3 (interquartile range 1-6) days and 90-day mortality 18.9%. A new five grade Gastrointestinal Dysfunction Score (GIDS) was developed based on the rationale of the previously developed Acute GI Injury (AGI) grading. Citrulline and I-FABP did not prove their potential for scoring of GI dysfunction in critically ill. GIDS was independently associated with 28- and 90-day mortality when added to SOFA total score (HR 1.40; 95%CI 1.07-1.84 and HR 1.40; 95%CI 1.02-1.79, respectively) or to a model containing all SOFA subscores (HR 1.48; 95%CI 1.13-1.92 and HR 1.47; 95%CI 1.15-1.87, respectively), improving predictive power of SOFA score in all analyses. CONCLUSIONS The newly developed GIDS is additive to SOFA score in prediction of 28- and 90-day mortality. The clinical usefulness of this score should be validated prospectively. TRIAL REGISTRATION NCT02613000, retrospectively registered 24 November 2015.
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Promotion of Regular Oesophageal Motility to Prevent Regurgitation and Enhance Nutrition Intake in Long-Stay ICU Patients. A Multicenter, Phase II, Sham-Controlled, Randomized Trial: The PROPEL Study.
Heyland, DK, Marquis, F, Lamontagne, F, Albert, M, Turgeon, AF, Khwaja, KA, Garland, A, Hall, R, Chapman, MG, Kutsiogannis, DJ, et al
Critical care medicine. 2020;(3):e219-e226
Abstract
OBJECTIVES To evaluate the effect of esophageal stimulation on nutritional adequacy in critically ill patients at risk for enteral feeding intolerance. DESIGN A multicenter randomized sham-controlled clinical trial. SETTING Twelve ICUs in Canada. PATIENTS We included mechanically ventilated ICU patients who were given moderate-to-high doses of opioids and expected to remain alive and ventilated for an additional 48 hours and who were receiving enteral nutrition or expected to start imminently. INTERVENTIONS Patients were randomly assigned 1:1 to esophageal stimulation via an esophageal stimulating catheter (E-Motion Tube; E-Motion Medical, Tel Aviv, Israel) or sham treatment. All patients were fed via these catheters using a standardized feeding protocol. MEASUREMENTS AND MAIN RESULTS The co-primary outcomes were proportion of caloric and protein prescription received enterally over the initial 7 days following randomization. Among 159 patients randomized, the modified intention-to-treat analysis included 155 patients: 73 patients in the active treatment group and 82 in the sham treatment group. Over the 7-day study period, the percent of prescribed caloric intake (± SE) received by the enteral route was 64% ± 2 in the active group and 65% ± 2 in sham patients for calories (difference, -1; 95% CI, -8 to 6; p = 0.74). For protein, it was 57% ± 3 in the active group and 60% ± 3 in the sham group (difference, -3; 95% CI, -10 to 3; p = 0.30). Compared to the sham group, there were more serious adverse events reported in the active treatment group (13 vs 6; p = 0.053). Clinically important arrhythmias were detected by Holter monitoring in 36 out of 70 (51%) in the active group versus 22 out of 76 (29%) in the sham group (p = 0.006). CONCLUSIONS Esophageal stimulation via a special feeding catheter did not improve nutritional adequacy and was associated with increase risk of harm in critically ill patients.
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Effect of Electrical Muscle Stimulation on Upper and Lower Limb Muscles in Critically Ill Patients: A Two-Center Randomized Controlled Trial.
Nakanishi, N, Oto, J, Tsutsumi, R, Yamamoto, T, Ueno, Y, Nakataki, E, Itagaki, T, Sakaue, H, Nishimura, M
Critical care medicine. 2020;(11):e997-e1003
Abstract
OBJECTIVES Electrical muscle stimulation is widely used to enhance lower limb mobilization. Although upper limb muscle atrophy is common in critically ill patients, electrical muscle stimulation application for the upper limbs has been rarely reported. The purpose of this study was to investigate whether electrical muscle stimulation prevents upper and lower limb muscle atrophy and improves physical function. DESIGN Randomized controlled trial. SETTING Two-center, mixed medical/surgical ICU. PATIENTS Adult patients who were expected to be mechanically ventilated for greater than 48 hours and stay in the ICU for greater than 5 days. INTERVENTIONS Forty-two patients were randomly assigned to the electrical muscle stimulation (n = 17) or control group (n = 19). MEASUREMENTS AND MAIN RESULTS Primary outcomes were change in muscle thickness and cross-sectional area of the biceps brachii and rectus femoris from day 1 to 5. Secondary outcomes included occurrence of ICU-acquired weakness, ICU mobility scale, length of hospitalization, and amino acid levels. The change in biceps brachii muscle thickness was -1.9% versus -11.2% in the electrical muscle stimulation and control (p = 0.007) groups, and the change in cross-sectional area was -2.7% versus -10.0% (p = 0.03). The change in rectus femoris muscle thickness was -0.9% versus -14.7% (p = 0.003) and cross-sectional area was -1.7% versus -10.4% (p = 0.04). No significant difference was found in ICU-acquired weakness (13% vs 40%; p = 0.20) and ICU mobility scale (3 vs 2; p = 0.42) between the groups. The length of hospitalization was shorter in the electrical muscle stimulation group (23 d [19-34 d] vs 40 d [26-64 d]) (p = 0.04). On day 3, the change in the branched-chain amino acid level was lower in the electrical muscle stimulation group (40.5% vs 71.5%; p = 0.04). CONCLUSIONS In critically ill patients, electrical muscle stimulation prevented upper and lower limb muscle atrophy and attenuated proteolysis and decreased the length of hospitalization.
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Effects of supplementation with curcuminoids on serum adipokines in critically ill patients: a randomized double-blind placebo-controlled trial.
Shadnoush, M, Zahedi, H, Norouzy, A, Sahebkar, A, Sadeghi, O, Najafi, A, Hosseini, S, Qorbani, M, Ahmadi, A, Ardehali, SH, et al
Phytotherapy research : PTR. 2020;(12):3180-3188
Abstract
Previous studies have shown a beneficial effect of curcuminoids supplementation on serum concentrations of adipokines; however, there are no published studies that have examined this effect among critically ill patients. We aimed to assess the effects of supplementation with curcuminoids on serum concentrations of leptin and adiponectin in critically ill patients with traumatic brain injury (TBI). In this trial, 62 critically ill patients with TBI, aged 18-65 years, were randomly allocated to receive either 500 mg/day curcuminoids (co-administered with 5 mg/day piperine) or matched placebo for 7 days. Patients in both intervention groups received routine treatments for TBI as well as enteral nutrition. Serum concentrations of leptin and adiponectin were measured at baseline and at the end of trial. We found a significant reduction in serum levels of leptin in both curcuminoids (47.1%) and placebo (22.8%) groups; though the magnitude of reduction was greater in the former (p < .05). Supplementation with curcumioinds was not found to alter serum concentrations of adiponectin (p > .05). Supplementation with curcumioinds significantly reduced serum levels of leptin but had no significant effect on adiponectin levels in critically ill patients with TBI. Further clinical trials, particularly those with a long-term period, are needed to confirm our findings.
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Intra-Abdominal Pressure as a Marker of Enteral Nutrition Intolerance in Critically Ill Patients. The PIANE Study.
Bordejé, ML, Montejo, JC, Mateu, ML, Solera, M, Acosta, JA, Juan, M, García-Córdoba, F, García-Martínez, MA, Gastaldo, R, ,
Nutrients. 2019;(11)
Abstract
To determine whether elevated intra-abdominal pressure (IAP) is associated with a higher rate of enteral nutrition-related gastrointestinal (GI) complications; to assess the value of IAP as a predictor of enteral nutrition (EN) intolerance. Intensive Care Unit (ICU) patients on mechanical ventilation requiring at least 5 days of EN were recruited for a prospective, observational, non-interventional, multicenter study. EN was performed and GI complications were managed with an established protocol. IAP was determined via a urinary catheter. Patients who developed any GI complications were considered as presenting EN intolerance. Variables related to EN, IAP and GI complications were monitored daily. Statistical analysis compared patients without GI complications (group A) vs. GI complications (group B). 247 patients were recruited from 28 participating ICUs (group A: 119, group B: 128). No differences between groups were recorded. Patients in group B (p < 0.001) spent more days on EN (8.1 ± 8.4 vs. 18.1 ± 13.7), on mechanical ventilation (8.0 ± 7.7 vs. 19.3 ± 14.9) and in the ICU (12.3 ± 11.4 vs. 24.8 ± 17.5). IAP prior to the GI complication was (14.3 ± 3.1 vs. 15.8 ± 4.8) (p < 0.003). The best IAP value identified for EN intolerance was 14 mmHg but it had low sensitivity and specificity. Although a higher IAP was associated with EN intolerance, IAP alone did not emerge as a good predictor of EN intolerance in critically ill patients.
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Urea reduction ratio may be a simpler approach for measurement of adequacy of intermittent hemodialysis in acute kidney injury.
Liang, KV, Zhang, JH, Palevsky, PM
BMC nephrology. 2019;(1):82
Abstract
BACKGROUND Assessment of adequacy of intermittent hemodialysis (IHD) is conventionally based upon urea kinetic models for calculation of single pool Kt/Vurea (Kt/V), with 1.2 accepted as minimum adequate clearance for thrice weekly IHD. In the Acute Renal Failure Trial Network (ATN) Study, adequacy of IHD in patients with acute kidney injury (AKI) was assessed using Kt/V. However, equations for Kt/V require volume of distribution of urea, which is highly variable in AKI. Therefore, simpler methods are needed to assess adequacy of IHD in AKI. We assessed correlation of urea reduction ratio (URR) with Kt/V and determined URR thresholds corresponding to Kt/V values to determine if URR could be a simpler means to assess the delivered dose of IHD. METHODS Using patients who received IHD for 2.5-6 h and with pre-dialysis BUN ≥20 mg/dL, we plotted URR against Kt/V. We determined URR thresholds (0.60 to 0.75) corresponding to Kt/V ≥ 1.2, 1.3, and 1.4. We generated receiver operating characteristic (ROC) curves for increasing URR values for each level of Kt/V to identify the corresponding thresholds of URR. RESULTS There was strong correlation between URR and Kt/V. ROC curves comparing URR with Kt/V ≥ 1.2, 1.3, and 1.4 had area under the curves (AUC) of 0.99. Sensitivity and specificity of URR ≥0.67 for corresponding values of Kt/V ≥ 1.2 were 0.769 (95% CI: 0.745 to 0.793) and 0.999 (95% CI: 0.997 to 1.000), respectively and the sensitivity and specificity of URR ≥0.67 for corresponding values of Kt/V ≥ 1.4 were 0.998 (95% CI: 0.995 to 1.000) and 0.791 (95% CI: 0.771 to 0.811), respectively. CONCLUSIONS Targeting a URR ≥0.67 provides a simplified means of assessing adequacy of IHD in patients with AKI. Use of URR will enhance ability to assess delivery of small solute clearance and improve adherence with clinical practice guidelines in AKI.
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Dietary Management of Blood Glucose in Medical Critically Ill Overweight and Obese Patients: An Open-Label Randomized Trial.
Rice, TW, Files, DC, Morris, PE, Bernard, AC, Ziegler, TR, Drover, JW, Kress, JP, Ham, KR, Grathwohl, DJ, Huhmann, MB, et al
JPEN. Journal of parenteral and enteral nutrition. 2019;(4):471-480
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Abstract
BACKGROUND Enteral nutrition (EN) increases hyperglycemia due to high carbohydrate concentrations while providing insufficient protein. The study tested whether an EN formula with very high-protein- and low-carbohydrate-facilitated glucose control delivered higher protein concentrations within a hypocaloric protocol. METHODS This was a multicenter, randomized, open-label clinical trial with parallel design in overweight/obese mechanically ventilated critically ill patients prescribed 1.5 g protein/kg ideal body weight/day. Patients received either an experimental very high-protein (37%) and low-carbohydrate (29%) or control high-protein (25%) and conventional-carbohydrate (45%) EN formula. RESULTS A prespecified interim analysis was performed after enrollment of 105 patients (52 experimental, 53 control). Protein and energy delivery for controls and experimental groups on days 1-5 were 1.2 ± 0.4 and 1.1 ± 0.3 g/kg ideal body weight/day (P = .83), and 18.2 ± 6.0 and 12.5 ± 3.7 kcals/kg ideal body weight/day (P < .0001), respectively. The combined rate of glucose events outside the range of >110 and ≤150 mg/dL were not different (P = .54, primary endpoint); thereby the trial was terminated. The mean blood glucose for the control and the experimental groups were 138 (-SD 108, +SD 177) and 126 (-SD 99, +SD 160) mg/dL (P = .004), respectively. Mean rate of glucose events >150 mg/dL decreased (Δ = -13%, P = .015), whereas that of 80-110 mg/dL increased (Δ = 14%, P = .0007). Insulin administration decreased 10.9% (95% CI, -22% to 0.1%; P = .048) in the experimental group relative to the controls. Glycemic events ≤80 mg/dL and rescue dextrose use were not different (P = .23 and P = .53). CONCLUSIONS A very high-protein and low-carbohydrate EN formula in a hypocaloric protocol reduces hyperglycemic events and insulin requirements while increasing glycemic events between 80-110 mg/dL.
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Nutrition Adequacy Therapeutic Enhancement in the Critically Ill: A Randomized Double-Blind, Placebo-Controlled Trial of the Motilin Receptor Agonist Camicinal (GSK962040): The NUTRIATE Study.
Deane, AM, Lamontagne, F, Dukes, GE, Neil, D, Vasist, L, Barton, ME, Hacquoil, K, Ou, X, Richards, D, Stelfox, HT, et al
JPEN. Journal of parenteral and enteral nutrition. 2018;(5):949-959
Abstract
BACKGROUND Camicinal is a novel, nonmacrolide, motilin receptor agonist that accelerates gastric emptying in critically ill patients with established feed intolerance. The primary question was whether the preemptive administration of camicinal increased the provision of enteral nutrition (EN) to critically ill patients with risk factors that predisposed to feed intolerance. METHODS This was an international, multicenter, parallel-group, blinded, randomized controlled trial. Patients at risk for feed intolerance, defined as receiving moderate to high doses of vasopressors or opiates, or admitted because of multiple traumatic injuries or with brain injury, received either enteral camicinal 50 mg or placebo daily for a maximum of 7 days, along with EN administered according to a standardized feeding protocol. The primary outcome was the daily adequacy of enteral feed delivered, as assessed by percentage of goal volume (delivered/prescribed × 100) before development of intolerance. RESULTS Eighty-four patients participated. The administration of camicinal did not result in a statistically significant clinical difference in the daily average percentage goal volume delivered (camicinal vs placebo: 77% [95% confidence interval: 71, 83] vs 68% (58, 78); mean difference 9% [-5, 23]; P = 0.21). Similarly, there were no differences in the percentage goal calories (76% [65, 88] vs 68% [60, 77]) and protein (76% [66, 86] vs 70% [61, 80]) administered, or the incidence of feed intolerance (15% vs 14%). CONCLUSION The incidence of feed intolerance was low in both groups. In this cohort the preemptive administration of enteral camicinal did not significantly augment the provision of goal EN.