DESIGN: A post hoc subgroup analysis of the effect of higher protein dosing in critically ill patients with high nutritional risk (EFFORT Protein): an international, multicenter, pragmatic, registry-based randomized trial.
SETTING: Eighty-five adult ICUs across 16 countries.
PATIENTS: Patients with obesity defined as a body mass index (BMI) greater than or equal to 30 kg/m 2 ( n = 425).
INTERVENTIONS: In the primary study, patients were randomized into a high-dose (≥ 2.2 g/kg/d) or usual-dose protein group (≤ 1.2 g/kg/d).
MEASUREMENTS AND MAIN RESULTS: Protein intake was monitored for up to 28 days, and outcomes (time to discharge alive [TTDA], 60-d mortality, days of mechanical ventilation [MV], hospital, and ICU length of stay [LOS]) were recorded until 60 days post-randomization. Of the 1301 patients in the primary study, 425 had a BMI greater than or equal to 30 kg/m 2 . After adjusting for sites and covariates, we observed a nonsignificant slower rate of TTDA with higher protein that ruled out a clinically important benefit (hazard ratio, 0.78; 95% CI, 0.58-1.05; p = 0.10). We found no evidence of difference in TTDA between protein groups when subgroups with different classes of obesity or patients with and without various nutritional and frailty risk variables were examined, even after the removal of patients with baseline acute kidney injury. Overall, 60-day mortality rates were 31.5% and 28.2% in the high protein and usual protein groups, respectively (risk difference, 3.3%; 95% CI, -5.4 to 12.1; p = 0.46). Duration of MV and LOS in hospital and ICU were not significantly different between groups.
CONCLUSIONS: In critically ill patients with obesity, higher protein doses did not improve clinical outcomes, including those with higher nutritional and frailty risk.
METHODS AND RESULTS: The MY-HF Registry is a 3-year prospective, observational study comprising 2717 Malaysian patients admitted for acute HF. We report the description of baseline data at admission and outcomes of index hospitalization of these patients. The mean age was 60.2 ± 13.6 years, 66.8% were male, and 34.3% had de novo HF. Collectively, 55.7% of patients presented with New York Heart Association (NYHA) Class III or IV; ischaemic heart disease was the most frequent aetiology (63.2%). Most admissions (87.3%) occurred via the emergency department, with 13.7% of patients requiring intensive care, and of these, 21.8% needed intubation. The proportion of patients receiving guideline-directed medical therapy increased at discharge (84.2% vs. 93.6%). The median length of stay (LOS) was 5 days, and in-hospital mortality was 2.9%. Predictors of LOS and/or in-hospital mortality were age, NYHA class, estimated glomerular filtration rate, and comorbid anaemia. LOS and in-hospital mortality were similar regardless of ejection fraction.
CONCLUSIONS: The MY-HF Registry showed that the HF population in Malaysia is younger, predominantly male, and ischaemic-driven and has good prospects with hospitalization for optimization of treatment. These findings suggest a need to reassess current clinical practice and guide resource allocation to improve patient outcomes.
OBJECTIVES: To conduct a systematic review to understand the rapid response team's (RRT) effect on patient outcomes.
METHODS: A systematic search was conducted using PubMed, Cochrane, Embase, CINAHL, Web of Science, and two trial registers. The studies published up to May 6, 2022, from the inception date of the databases were included. Two researchers filtered the title, abstract and full text. The Version 2 of the Cochrane Risk of Bias tool and Bias in Non-Randomized Studies of Interventions (ROBINS-I) tool were used separately for randomized and non-randomized controlled trials for quality appraisal.
RESULTS: Sixty-one eligible studies were identified, four randomized controlled trials(RCTs), four non-randomized controlled trials, six interrupted time-series(ITS) design , and 47 pretest-posttest studies. A total of 52 studies reported hospital mortality, 51 studies reported cardiopulmonary arrests, 18 studies reported unplanned ICU admissions and ten studies reported LOS.
CONCLUSION: This systematic review found the variation in context and the type of RRT interventions restricts direct comparisons. The evidence for improving several aspects of patient outcomes was inconsistent, with most studies demonstrating that RRT positively impacts patient outcomes.
METHODS: A decision tree model was developed based on literature and expert inputs. An epidemiological projection model was then added to the decision tree to calculate the target population size. The budget impact of adapting the different enteral nutrition (EN) formulas was calculated by multiplying the population size with the costs of the formula and ICU length of stay (LOS). A one-way sensitivity analysis (OWSA) was conducted to examine the effect each input parameter has on the calculated output.
RESULTS: Replacing SPF with SEF would lower ICU cost by MYR 1059 (USD 216) per patient. The additional cost of increased LOS due to EFI was MYR 5460 (USD 1114) per patient. If the MOH replaces SPF with SEF for ICU patients with high EFI risk (estimated 7981 patients in 2022), an annual net cost reduction of MYR 8.4 million (USD 1.7 million) could potentially be realized in the MOH system. The cost-reduction finding of replacing SPF with SEF remained unchanged despite the input uncertainties assessed via OWSA.
CONCLUSION: Early use of SEF in ICU patients with high EFI risk could potentially lower the cost of ICU care for the MOH system in Malaysia.
METHODS: In this post hoc analysis of the EFFORT Protein trial, we investigated the effect of high versus usual protein dose (≥ 2.2 vs. ≤ 1.2 g/kg body weight/day) on time-to-discharge alive from the hospital (TTDA) and 60-day mortality and in different subgroups in critically ill patients with AKI as defined by the Kidney Disease Improving Global Outcomes (KDIGO) criteria within 7 days of ICU admission. The associations of protein dose with incidence and duration of kidney replacement therapy (KRT) were also investigated.
RESULTS: Of the 1329 randomized patients, 312 developed AKI and were included in this analysis (163 in the high and 149 in the usual protein dose group). High protein was associated with a slower time-to-discharge alive from the hospital (TTDA) (hazard ratio 0.5, 95% CI 0.4-0.8) and higher 60-day mortality (relative risk 1.4 (95% CI 1.1-1.8). Effect modification was not statistically significant for any subgroup, and no subgroups suggested a beneficial effect of higher protein, although the harmful effect of higher protein target appeared to disappear in patients who received kidney replacement therapy (KRT). Protein dose was not significantly associated with the incidence of AKI and KRT or duration of KRT.
CONCLUSIONS: In critically ill patients with AKI, high protein may be associated with worse outcomes in all AKI stages. Recommendation of higher protein dosing in AKI patients should be carefully re-evaluated to avoid potential harmful effects especially in patients who were not treated with KRT.
TRIAL REGISTRATION: This study is registered at ClinicalTrials.gov (NCT03160547) on May 17th 2017.
MATERIALS AND METHODS: Written medical records of burn patients admitted to the Sultanah Aminah Hospital paediatric surgical ward, from January 2016 to December 2018, were retrospectively reviewed. Details on the patients' socio-demographic background, burn injuries, management and outcomes were recorded and analysed with logistic regression.
RESULTS AND CONCLUSION: Of the 255 children included in the study, the majority were males (62.7%), children aged between 1 to 3 years (43.1%), and of the Malay ethnic group (83.1%). The commonest injury mechanism was scalds burns (81.2%). Staphylococcus aureus remained the commonest organism cultured from paediatric burn wounds. Most patients (66.4%) were hospitalised for less than 1 week. A significant number of patients experienced complications from their injuries. Multivariate analysis showed burns affecting total body surface area > 10% (adjusted OR, 13.45 [95% CI 6.25 - 28.96]; p = < 0.001) and non-scald burns (adjusted OR, 2.70 [95% CI 1.12 - 6.50]; p = 0.027) were the two main factors associated with prolonged hospitalisation of more than 1 week. These findings describing the epidemiology and outcomes of paediatric burn cases in a tertiary centre in Malaysia may inform future practice. More importantly, the information may contribute to the identification of at-risk populations and advise the development of effective prevention strategies to reduce the incidence and morbidity associated with paediatric burns in this region.
DATA SOURCES: MEDLINE, Embase, CINAHL, and Cochrane Central were searched from inception to February 10, 2023.
STUDY SELECTION: RCTs evaluating the effect of enteral or IV glutamine supplementation alone in severe adult burn patients were included.
DATA EXTRACTION: Two reviewers independently extracted data on study characteristics, burn injury characteristics, description of the intervention between groups, adverse events, and clinical outcomes.
DATA SYNTHESIS: Random effects meta-analyses were performed to estimate the pooled risk ratio (RR). Trial sequential analyses (TSA) for mortality and infectious complications were performed. Ten RCTs (1,577 patients) were included. We observed no significant effect of glutamine supplementation on overall mortality (RR, 0.65, 95% CI, 0.33-1.28; p = 0.21), infectious complications (RR, 0.83; 95% CI, 0.63-1.09; p = 0.18), or other secondary outcomes. In subgroup analyses, we observed no significant effects based on administration route or burn severity. We did observe a significant subgroup effect between single and multicenter RCTs in which glutamine significantly reduced mortality and infectious complications in singe-center RCTs but not in multicenter RCTs. However, TSA showed that the pooled results of single-center RCTs were type 1 errors and further trials would be futile.
CONCLUSIONS: Glutamine supplementation, regardless of administration, does not appear to improve clinical outcomes in severely adult burned patients.
METHODS AND ANALYSIS: This is double-blind randomised controlled trial, with parallel group, concealed allocation, blinding of patients and assessors, and intention-to-treat analysis. 240 adult participants who had median sternotomy from eight hospitals in Malaysia will be recruited. Sample size calculations were based on the unsupported upper limb test. All participants will be randomised to receive either standard or early supervised incremental resistance training. The primary outcomes are upper limb function and pain. The secondary outcomes will be functional capacity, multidomain recovery (physical and psychological), length of hospital stay, incidence of respiratory complications and quality of life. Descriptive statistics will be used to summarise data. Data will be analysed using the intention-to-treat principle. The primary hypothesis will be examined by evaluating the change from baseline to the 4-week postoperative time point in the intervention arm compared with the usual care arm. For all tests to be conducted, a p value of <0.05 (two tailed) will be considered statistically significant, and CIs will be reported. The trial is currently recruiting participants.
ETHICS AND DISSEMINATION: The study was approved by a central ethical committee as well as the local Research Ethics Boards of the participating sites (UKM:JEP-2019-654; Ministry of Health: NMMR-50763; National Heart Centre: IJNREC/501/2021). Approval to start was given prior to the recruitment of participants commencing at any sites. Process evaluation findings will be published in peer-reviewed journals and presented at relevant academic conferences.
TRIAL REGISTRATION NUMBER: International Standard Randomised Controlled Trials Number (ISRCTN17842822).
METHODS: This is a retrospective review of all mechanically ventilated surgical patients in the wards, in a tertiary hospital, in 2020. Sixty-two patients out of 116 patients ventilated in surgical wards fulfilled the inclusion criteria. Demography, surgical diagnosis and procedures and physiologic, biochemical and survival data were analyzed to explore the outcomes and predictors of mortality.
RESULTS: Twenty-two out of 62 patients eventually gained ICU admission. Mean time from intubation to ICU entry and mean length of ICU stay were 48 h (0 to 312) and 10 days (1 to 33), respectively. Survival for patients admitted to ICU compared to ventilation in the acute surgery wards was 54.5% (12/22) vs 17.5% (7/40). Thirty-four patients underwent surgery, and the majority were bowel-related emergency operations. SAPS2 score validation revealed AUC of 0.701. More than half of patients with mortality risk
AIMS: We aimed to perform a meta-analysis of randomized trials investigating the effect of colchicine in patients with COVID-19.
MATERIALS & METHODS: We systematically searched electronic databases and clinical trial registries (up to October 17, 2021) for eligible studies. The outcomes of interest were all-cause mortality and duration of hospital stay. Meta-analysis with the random-effects model was used to estimate the pooled odds ratio (OR) of mortality and 95% confidence interval (CI). The pooled standardized mean difference of duration of hospital stay with 95% CI between colchicine users and non-colchicine users was estimated using Cohen's d index.
RESULTS: The meta-analyses revealed no significant difference in the odds of mortality (pooled OR = 0.76; 95% CI: 0.53-1.07), but a significant reduction in the duration of hospital stay with the use of colchicine (pooled standardized mean difference = -0.59; 95% CI: -1.06 to -0.13).
DISCUSSION AND CONCLUSION: The ability of colchicine to reduce the length of stay in hospitalized patients with COVID-19 is consistent with its potential to prevent clinical deterioration via inhibition of NLRP3 inflammasome. Nevertheless, such beneficial effects of colchicine did not translate into mortality benefits in patients with COVID-19.
METHODS: This was a randomized controlled trial at 2 centers. A total of 78 patients requiring DC were randomized in a 1:1:1 ratio into 3 groups: vacuum drains (VD), passive drains (PD), and no drains (ND). Complications studied were need for surgical revision, SGH amount, new remote hematomas, postcraniectomy hydrocephalus (PCH), functional outcomes, and mortality.
RESULTS: Only 1 VD patient required surgical revision to evacuate SGH. There was no difference in SGH thickness and volume among the 3 drain types (P = 0.171 and P = 0.320, respectively). Rate of new remote hematoma and PCH was not significantly different (P = 0.647 and P = 0.083, respectively), but the ND group did not have any patient with PCH. In the subgroup analysis of 49 patients with traumatic brain injury, the SGH amount of the PD and ND group was significantly higher than that of the VD group. However, these higher amounts did not translate as a significant risk factor for poor functional outcome or mortality. VD may have better functional outcome and mortality.
CONCLUSIONS: In terms of complication rates, VD, PD, and ND may be used safely in DC. A higher amount of SGH was not associated with poorer outcomes. Further studies are needed to clarify the advantage of VD regarding functional outcome and mortality, and if ND reduces PCH rates.
MATERIAL AND METHODS: A randomized trial was conducted in the University of Malaya Medical Center. A total of 163 term multiparas (no dropouts) with unripe cervixes (Bishop score ≤5) scheduled for labor induction were randomized to outpatient or inpatient Foley catheter. Primary outcomes were delivery during "working hours" 08:00-18:00 h and maternal satisfaction on allocated care (assessed by 11-point visual numerical rating score 0-10, with higher score indicating more satisfied).
CLINICAL TRIAL REGISTRATION: ISRCTN13534944.
RESULTS: Comparing outpatient and inpatient arms, delivery during working hours were 54/82 (65.9%) vs. 48/81 (59.3%) (relative risk 1.1, 95% CI 0.9-1.4, p = 0.421) and median maternal satisfaction visual numerical rating score was 9 (interquartile range 9-9) vs. 9 (interquartile range 8-9, p = 0.134), repectively. Duration of hospital stay and membrane rupture to delivery interval were significantly shorter in the outpatient arm: 35.8 ± 20.2 vs. 45.2 ± 16.2 h (p = 0.001) and 4.1 ± 2.9 vs. 5.3 ± 3.6 h (p = 0.020), respectively. Other maternal and neonatal secondary outcomes were not significantly different.
CONCLUSIONS: The trial failed to demonstrate the anticipated increase in births during working hours with outpatient compared with inpatient induction of labor with Foley catheter in parous women with an unripe cervix. Hospital stay and membrane rupture to delivery interval were significantly shortened in the outpatient group. The rate of maternal satisfaction was high in both groups and no significant differences were found.
METHOD: This is a non-interventional, retrospective analysis of documented CPI in a 100-bed, acute-care private hospital in Amman, Jordan. Study consisted of 542 patients, 574 admissions, and 1694 CPI. Team collected demographic and clinical data using a standardized tool. Input consisted of 54 variables with some taking merely repetitive values for each CPI in each patient whereas others varying with every CPI. Therefore, CPI was consolidated to one rejected and/or one accepted per patient per admission. Groups of accepted and rejected CPI were compared in terms of matched and unmatched variables. ANN were, subsequently, trained and internally as well as cross validated for outcomes of interest. Outcomes were length of hospital and intensive care stay after the index CPI (LOSTA & LOSICUA, respectively), readmissions, mortality, and cost of hospitalization. Best models were finally used to compare the two scenarios of approving 80% versus 100% of CPI. Variable impacts (VI) automatically generated by the ANN were compared to evaluate the effect of rejecting CPI. Main outcome measure was Lengths of hospital stay after the index CPI (LOSTA).
RESULTS: ANN configurations converged within 18 s and 300 trials. All models showed a significant reduction in LOSTA with 100% versus 80% accepted CPI of about 0.4 days (2.6 ± 3.4, median (range) of 2 (0-28) versus 3.0 ± 3.8, 2 (0-30), P-value = 0.022). Average savings with acceptance of those rejected CPI was 55 JD (~ 78 US dollars) and could help hire about 1.3 extra clinical pharmacist full-time equivalents.
CONCLUSIONS: Maximizing acceptance of CPI reduced the length of hospital stay in this model. Practicing Clinical Pharmacists may qualify for further privileges including promotion to a fully independent prescriber status.
Purpose: To report the perioperative and radiological outcomes of single-stage posterior passive correction and fusion (SSPPCF) in adolescent patients who present with congenital scoliosis.
Overview of Literature: The surgical treatment for congenital scoliosis is complex. There is no definitive guide on surgical options for skeletally matured adolescent patients who have congenital scoliosis.
Methods: Patients with congenital scoliosis who underwent SSPPCF using a pedicle screw system were reviewed. We identified the following three surgical indications: (1) hemivertebra or wedge vertebra over the thoracic or thoracolumbar region with structural lumbar curves, (2) hemivertebra or wedge vertebra at the lumbar region with significant pelvic obliquity or sacral slanting, and (3) mixed or complex congenital scoliosis. The demographic, perioperative, and radiographic data of these patients were collected.
Results: Thirty-four patients were reviewed. The mean patient age was 14.6±3.4 years. There were 13 hemivertebrae, three wedged vertebrae, two butterfly vertebrae, three hemivertebrae with butterfly vertebra, eight unsegmented bars, and five multiple complex lesions. The average surgical duration was 219.4±68.8 minutes. The average blood loss was 1,208.4±763.5 mL. Seven patients required allogeneic blood transfusion. The mean hospital stay duration was 6.1±2.5 days. The complication rate was 11.8% (4/34): one patient had severe blood loss, one had rod breakage, and two had distal adding-on. The Cobb angle reduced from 65.9°±17.4° to 36.3°±15.3° (p<0.001) with a correction rate (CR) of 44.8%±17.4%. The regional kyphotic angle decreased from 39.9°±20.5° to 27.5°±13.9° (p=0.001) with a CR of 19.3%±49.6%. Radiographic parameters (radiographic shoulder height, clavicle angle, T1 tilt, cervical axis, pelvic obliquity, coronal balance, and apical vertebral translation) showed significant improvement postoperatively.
Conclusions: SSPPCF was a feasible option for adolescent patients with congenital scoliosis who were skeletally matured.