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Supplemental parenteral nutrition in critically ill patients: a study protocol for a phase II randomised controlled trial.

ABSTRACT: Nutrition is one of the fundamentals of care provided to critically ill adults. The volume of enteral nutrition received, however, is often much less than prescribed due to multiple functional and process issues. To deliver the prescribed volume and correct the energy deficit associated with enteral nutrition alone, parenteral nutrition can be used in combination (termed "supplemental parenteral nutrition"), but benefits of this method have not been firmly established. A multi-centre, randomised, clinical trial is currently underway to determine if prescribed energy requirements can be provided to critically ill patients by using a supplemental parenteral nutrition strategy in the critically ill.This prospective, multi-centre, randomised, stratified, parallel-group, controlled, phase II trial aims to determine whether a supplemental parenteral nutrition strategy will reliably and safely increase energy intake when compared to usual care. The study will be conducted for 100 critically ill adults with at least one organ system failure and evidence of insufficient enteral intake from six intensive care units in Australia and New Zealand. Enrolled patients will be allocated to either a supplemental parenteral nutrition strategy for 7 days post randomisation or to usual care with enteral nutrition. The primary outcome will be the average energy amount delivered from nutrition therapy over the first 7 days of the study period. Secondary outcomes include protein delivery for 7 days post randomisation; total energy and protein delivery, antibiotic use and organ failure rates (up to 28 days); duration of ventilation, length of intensive care unit and hospital stay. At both intensive care unit and hospital discharge strength and health-related quality of life assessments will be undertaken. Study participants will be followed up for health-related quality of life, resource utilisation and survival at 90 and 180 days post randomisation (unless death occurs first).This trial aims to determine if provision of a supplemental parenteral nutrition strategy to critically ill adults will increase energy intake compared to usual care in Australia and New Zealand. Trial outcomes will guide development of a subsequent larger randomised controlled trial.NCT01847534 (First registered 5 February 2013, last updated 14 October 2015).

SUBMITTER: Ridley EJ

PROVIDER: S-EPMC4690293 | biostudies-literature | 2015 Dec

REPOSITORIES: biostudies-literature

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Project description:BACKGROUND:In the critically ill, energy delivery from enteral nutrition (EN) is often less than the estimated energy requirement. Parenteral nutrition (PN) as a supplement to EN may increase energy delivery. We aimed to determine if an individually titrated supplemental PN strategy commenced 48-72 hours following ICU admission and continued for up to 7 days would increase energy delivery to critically ill adults compared to usual care EN delivery. METHODS:This study was a prospective, parallel group, phase II pilot trial conducted in six intensive care units in Australia and New Zealand. Mechanically ventilated adults with at least one organ failure and EN delivery below 80% of estimated energy requirement in the previous 24 hours received either a supplemental PN strategy (intervention group) or usual care EN delivery. EN in the usual care group could be supplemented with PN if EN remained insufficient after usual methods to optimise delivery were attempted. RESULTS:There were 100 patients included in the study and 99 analysed. Overall, 71% of the study population were male, with a mean (SD) age of 59 (17) years, Acute Physiology and Chronic Health Evaluation II score of 18.2 (6.7) and body mass index of 29.6 (5.8) kg/m2. Significantly greater energy (mean (SD) 1712 (511) calories vs. 1130 (601) calories, p?<?0.0001) and proportion of estimated energy requirement (mean (SD) 83 (25) % vs. 53 (29) %, p?<?0.0001) from EN and/or PN was delivered to the intervention group compared to usual care. Delivery of protein and proportion of estimated protein requirements were also greater in the intervention group (mean (SD) 86 (25) g, 86 (23) %) compared to usual care (mean (SD) 53 (29) g, 51 (25) %, p?<?0.0001). Antibiotic use, ICU and hospital length of stay, mortality and functional outcomes were similar between the two groups. CONCLUSIONS:This individually titrated supplemental PN strategy applied over 7 days significantly increased energy delivery when compared to usual care delivery. Clinical and functional outcomes were similar between the two patient groups. TRIAL REGISTRATION:Clinical Trial registry details: NCT01847534 (First registered 22 April 2013, last updated 31 July 2016).

Project description:Nutrition guidelines recommendations differ on the use of parenteral nutrition (PN), and existing clinical trial data are inconclusive. Our recent observational data show that amounts of energy/protein received early in the intensive care unit (ICU) affect patient mortality, particularly for inadequate nutrition intake in patients with body mass indices (BMIs) of <25 or >35. Thus, we hypothesized increased nutrition delivery via supplemental PN (SPN)?+?enteral nutrition (EN) to underweight and obese ICU patients would improve 60-day survival and quality of life (QoL) versus usual care (EN alone).In this multicenter, randomized, controlled pilot trial completed in 11 centers across four countries, adult ICU patients with acute respiratory failure expected to require mechanical ventilation for >72 hours and with a BMI of <25 or ?35 were randomized to receive EN alone or SPN?+?EN to reach 100% of their prescribed nutrition goal for 7 days after randomization. The primary aim of this pilot trial was to achieve a 30% improvement in nutrition delivery.In total, 125 patients were enrolled. Over the first 7 post-randomization ICU days, patients in the SPN?+?EN arm had a 26% increase in delivered calories and protein, whereas patients in the EN-alone arm had a 22% increase (both p?<?0.001). Surgical ICU patients received poorer EN nutrition delivery and had a significantly greater increase in calorie and protein delivery when receiving SPN versus medical ICU patients. SPN proved feasible to deliver with our prescribed protocol. In this pilot trial, no significant outcome differences were observed between groups, including no difference in infection risk. Potential, although statistically insignificant, trends of reduced hospital mortality and improved discharge functional outcomes and QoL outcomes in the SPN?+?EN group versus the EN-alone group were observed.Provision of SPN?+?EN significantly increased calorie/protein delivery over the first week of ICU residence versus EN alone. This was achieved with no increased infection risk. Given feasibility and consistent encouraging trends in hospital mortality, QoL, and functional endpoints, a full-scale trial of SPN powered to assess these clinical outcome endpoints in high-nutritional-risk ICU patients is indicated-potentially focusing on the more poorly EN-fed surgical ICU setting.NCT01206166.

Project description:ObjectiveSeveral observational studies have demonstrated that increased nutritional delivery by supplemental parenteral nutrition (SPN) plus enteral nutrition (EN) reduces the rate of all-cause mortality in critically ill patients. Therefore, we aimed to compare and evaluate the effect of SPN plus EN on all-cause mortality in critically ill adults.MethodsRandomized controlled trials were retrieved from PubMed, Embase, Google Scholar, Cochrane Library, and Sinomed (up to May 2021). Adults with severe illness treated with SPN plus EN or with EN alone were enrolled. The risk of bias was evaluated using the Newcastle-Ottawa scale, and a meta-analysis was conducted using Stata software. The primary outcome was all-cause mortality and was evaluated by pooled odds ratio (OR) with the fixed-effects model. Required information size was also calculated using trial sequential analysis.ResultsWe identified 10 randomized controlled trials, with a total of 6,908 patients. No significant differences in rate of all-cause mortality (OR = 0.96, 95% CI: 0.84-1.09, P = 0.518), intensive care unit (ICU) mortality (OR = 0.90, 95% CI: 0.75-1.07, P = 0.229), and hospital mortality (OR = 0.95, 95% CI: 0.82-1.10, P = 0.482) were found between the SPN plus EN and EN alone groups. SPN plus EN support was associated with a significantly decreased risk of infection (OR = 0.83, 95% CI: 0.74-0.93, P = 0.001), although the duration of mechanical ventilation [standardized mean difference (SMD) = - 0.20], length of hospital stay (SMD = 0.12), and ICU stay (SMD = - 0.57) were similar between the two groups (all P > 0.05). Meta-regression analyses showed no significant correlations between all-cause mortality and baseline clinical factors, including patients' age, the Acute Physiology and Chronic Health Evaluation II (APACHE II) score, time of SPN initiation, and follow-up duration (all P > 0.05). Subgroup analysis showed that SPN plus EN support was associated with a trend toward decreased rate of all-cause mortality in studies with follow-up < 30 days (OR = 0.61, 95% CI: 0.36-1.02, P = 0.058). Trial sequence analysis showed that the required information size for all-cause mortality was 16,972, and the cumulative Z-curve indicated no significant differences in the risk of all-cause mortality between the two groups (P > 0.05).ConclusionSPN plus EN support can significantly reduce the risk of infection, although it has no significant effect on all-cause mortality among critically ill patients. More studies are warranted to confirm these findings.

Project description:BackgroundParenteral nutrition (PN) is needed to avoid the development of malnutrition when enteral nutrition (EN) is not possible. Our main aim was to assess the current use, complications, and nutrition delivery associated with PN administration in adult critically ill patients, especially when used early and as the initial route. We also assessed the differences between patients who received only PN and those in whom EN was initiated after PN (PN-EN).MethodsA multicenter (n = 37) prospective observational study was performed. Patient clinical characteristics, outcomes, and nutrition-related variables were recorded. Statistical differences between subgroups were analyzed accordingly.ResultsFrom the entire population (n = 629), 186 (29.6%) patients received PN as initial nutrition therapy. Of these, 74 patients (11.7%) also received EN during their ICU stay (i.e., PN-EN subgroup). PN was administered early (<48 h) in the majority of patients (75.3%; n = 140) and the mean caloric (19.94 ± 6.72 Kcal/kg/day) and protein (1.01 ± 0.41 g/kg/day) delivery was similar to other contemporary studies. PN showed similar nutritional delivery when compared with the enteral route. No significant complications were associated with the use of PN. Thirty-two patients (43.3%) presented with EN-related complications in the PN-EN subgroup but received a higher mean protein delivery (0.95 ± 0.43 vs 1.17 ± 0.36 g/kg/day; p = 0.03) compared with PN alone. Once adjusted for confounding factors, patients who received PN alone had a lower mean protein intake (hazard ratio (HR): 0.29; 95% confidence interval (CI): 0.18-0.47; p = 0.001), shorter ICU stay (HR: 0.96; 95% CI: 0.91-0.99; p = 0.008), and fewer days on mechanical ventilation (HR: 0.85; 95% CI: 0.81-0.89; p = 0.001) compared with the PN-EN subgroup.ConclusionThe parenteral route may be safe, even when administered early, and may provide adequate nutrition delivery. Additional EN, when possible, may optimize protein requirements, especially in more severe patients who received initial PN and are expected to have longer ICU stays. NCT Registry: 03634943.

Project description:BackgroundThe state-of-the-art nutrition used for critically ill children is based essentially on expert opinion and extrapolations from adult studies or on studies in non-critically ill children. In critically ill adults, withholding parenteral nutrition (PN) during the first week in ICU improved outcome, as compared with early supplementation of insufficient enteral nutrition (EN) with PN. We hypothesized that withholding PN in children early during critical illness reduces the incidence of new infections and accelerates recovery.Methods/designThe Pediatric Early versus Late Parenteral Nutrition in Intensive Care Unit (PEPaNIC) study is an investigator-initiated, international, multicenter, randomized controlled trial (RCT) in three tertiary referral pediatric intensive care units (PICUs) in three countries on two continents. This study compares early versus late initiation of PN when EN fails to reach preset caloric targets in critically ill children. In the early-PN (control, standard of care) group, PN comprising glucose, lipids and amino acids is administered within the first days to reach the caloric target. In the late-PN (intervention) group, PN completing EN is only initiated beyond PICU-day 7, when EN fails. For both study groups, an early EN protocol is applied and micronutrients are administered intravenously. The primary assessor-blinded outcome measures are the incidence of new infections during PICU-stay and the duration of intensive care dependency. The sample size (n = 1,440, 720 per arm) was determined in order to detect a 5% absolute reduction in PICU infections, with at least 80% 1-tailed power (70% 2-tailed) and an alpha error rate of 5%. Based on the actual incidence of new PICU infections in the control group, the required sample size was confirmed at the time of an a priori- planned interim-analysis focusing on the incidence of new infections in the control group only.DiscussionClinical evidence in favor of early administration of PN in critically ill children is currently lacking, despite potential benefit but also known side effects. This large international RCT will help physicians to gain more insight in the clinical effects of omitting PN during the first week of critical illness in children.Trial registrationClinicalTrials.gov: NCT01536275 on 16 February 2012.

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Supplemental parenteral nutrition in critically ill patients: a study protocol for a phase II randomised controlled trial.

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