Safety and efficacy of three enteral feeding strategies in patients with severe stroke in China (OPENS): a multicentre, prospective, randomised, open-label, blinded-endpoint trial.

BACKGROUND: Early enteral nutrition is crucial for preventing malnutrition and improving outcomes in patients with severe stroke, but previous trials have provided conflicting results regarding the optimal nutritional strategy. We aimed to compare the efficacy and safety of three enteral feeding strategies in patients with severe stroke. METHODS: The Optimizing Early Enteral Nutrition in Severe Stroke (OPENS) study was a multicentre, investigator-initiated, prospective, open-label, randomised controlled trial, with blinded outcome assessment, in 16 tertiary and district general hospitals in the west of China. Adult patients with acute severe ischaemic or haemorrhagic stroke (Glasgow Coma Scale score ≤12 or National Institutes of Health Stroke Scale score ≥11 on admission) who were expected to receive enteral nutrition for more than 7 days were randomly assigned (1:1:1) to full enteral nutrition (70-100% of estimated caloric requirements), modified full enteral nutrition (full enteral nutrition plus prokinetic agents), or hypocaloric enteral nutrition (40-60% of estimated caloric requirements) via a centralised web-based randomisation system. The assigned nutrition was initiated within 24 h after enrolment and continued for 7 days. The computer-generated randomisation sequence was prepared by a statistician not involved with the rest of the study. Randomisation was done with an automated permuted block size of six. The allocation was unblinded to participants and investigators. The primary efficacy outcome was the proportion of participants with poor outcome (modified Rankin Scale score ≥3) at day 90 and the prespecified primary safety outcome was mortality at day 90, assessed in the intention-to-treat population. The trial is registered with ClinicalTrials.gov, NCT02982668. FINDINGS: Between Jan 15, 2017, and Sept 23, 2020, 321 patients were randomly assigned (107 in each group) and 315 patients (175 [56%] men, median age 71 years, IQR 60-78) were included in the final analysis. The study was terminated ahead of schedule on Sept 23, 2020, because a significant difference between groups was detected in mortality. The proportion of participants with poor outcomes at 90 days did not differ (modified full enteral nutrition 86 [82%] of 105 patients vs full enteral nutrition 85 [80%] of 106 patients, adjusted odds ratio [OR] 0·87, 95% CI 0·41-1·86, p=0·721; hypocaloric enteral nutrition 76 [73%] of 104 patients vs full enteral nutrition 0·61, 0·30-1·27, p=0·186; hypocaloric enteral nutrition vs modified full enteral nutrition 0·70, 0·34-1·46, p=0·340). Hypocaloric enteral nutrition showed significantly higher 90-day mortality than did modified full enteral nutrition (35 [34%] of 104 patients vs 18 [17%] of 105 patients, adjusted OR 2·89, 95% CI 1·46-5·72; p=0·0023), whereas the difference was not significant between hypocaloric enteral nutrition and full enteral nutrition (24 [23%] of 106 patients; adjusted OR 1·92, 95% CI 1·00-3·69; p=0·049), and between modified full enteral nutrition and full enteral nutrition (adjusted OR 0·61, 0·29-1·28; p=0·187). The most common adverse event was pneumonia, the incidence of which showed no significant difference among groups (full enteral nutrition 82 [78%] of 105 patients, modified full enteral nutrition 83 [81%] of 103 patients, hypocaloric enteral nutrition 78 [75%] of 104 patients; p=0·625). INTERPRETATION: In the early phase of severe stroke, modified full enteral nutrition or hypocaloric enteral nutrition did not significantly reduce the risk of a poor outcomes compared with full enteral nutrition over a 90-day period. Hypocaloric enteral nutrition might be associated with increased mortality compared with modified full enteral nutrition. Further studies are needed to investigate whether modified full enteral nutrition might be the optimal strategy. FUNDING: Shaanxi province Key Research and Development Project.

Optimizing early enteral nutrition in severe stroke (OPENS): protocol for a multicentre randomized controlled trial.

BACKGROUND: Malnutrition is one of the crucial factors associated with poor prognosis in critical ill patients, yet a significant evidence gap surrounds the management of initial enteral feeding in severe stroke. The Optimizing Early Enteral Nutrition in Severe Stroke (OPENS) trial will compare a strategy of modified full enteral nutrition (EN) (standard full EN in conjunction with prokinetic drug) and a strategy of permissive underfeeding (40 to 60% of estimated caloric requirements) with standard full EN (advancement to target nutrition goals) in patients with severe stroke. METHODS: The OPENS trial is a multicenter randomized controlled study. A total of 600 adult patients with severe stroke will be enrolled in 12 study sites in China, and randomized to standard full EN, modified full EN, or permissive underfeeding. The primary outcome measurement is the proportion of participants with a poor outcome (modified Rankin Scale ≥3) at day 90 of enrollment. Secondary outcomes include incidence rates of complications during hospitalization, disability at hospital discharge, and the ability of activities of daily living at day 90 of enrollment. The relationship between intervention and the primary outcome will be analyzed using multivariate logistic regression adjusted for study site, demographics, and baseline characteristics. DISCUSSION: The OPENS trial will explore the optimum initial feeding strategy for acute severe stroke. This trial is, therefore, an important step in bridging the evidence gap surrounding the enteral feeding for patients with severe stroke during the first week of hospitalization. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02982668 ; First Posted: December 5, 2016.

Surgical Technique for Subtrochanteric Fracture of Femur.

A 56-year-old woman had fell over herself 4 h prior to her presentation to our hospital. The diagnosis was a subtrochanteric fracture of the right femur (AO-32-A3). The patient was placed in a supine position was set up on a fracture traction table after general anesthesia. The right leg was placed in abduction while the left leg was positioned so that there was flexion of the knee and hip joint. The C-arm was placed on the left side. The surgical field was sterilized and draped. Deformity and external rotation are always present for this type of fracture, so the first step was to place a joystick in the proximal fragment to correct the external rotation. Then the perfect entry point could be defined by K wire. After inserting guide wire into the canal dreaming was followed. An appropriate nail was selected and inserted. The distal tip of the nail should be located in the cancellous bone. Before inserting the proximal lag screws into the femoral head, the external rotation of the proximal fragment must be corrected by the joystick. The traction was loosened and the distal fragment was pushed towards the proximal side so that the gap between the fragments disappeared. The affected leg was maintained in perfect alignment. Meanwhile, the distal locking screws were inserted using the free hand perfect circle technique.

Iliac bars lever reduction and fixation system used in the treatment of spondylolisthesis.

BACKGROUND: The purpose of the current study was to use the Iliac Bars Lever Reduction and Fixation System (IBLRFS) for Grades 1 and 2 spondylolytic spondylolisthesis, evaluate its stability and reductive efficacy, and examine the complications. METHODS: Between April 2005 and August 2006, 44 patients with Grades 1 and 2 spondylolytic spondylolisthesis were treated surgically: 21 patients underwent posterior Iliac Bars Lever Reduction and Fixation (IBRLFS), 23 patients were treated with traditional stabilization and reduction systems (SRS). The follow-up periods ranged from 1 to 2 years (mean, 1 year and 2 months). The clinical outcome, fusion rate, average percentile degree of displacement, displacement angle, sacral inclination, ratio of intervertebral height, and complications were evaluated. Operating time, blood loss, and duration of hospital stay were compared. RESULTS: There were no statistically significant differences between the 2 groups in blood loss, recovery rate, and radiographic results. However, there were statistically significant differences in operating time (P < .05), duration of hospital stay (P < .05). There were no cases of nonunion in the two groups. In the IBLRFS group, preoperatively, the average percentile degree of displacement, displacement angle, sacral inclination, and ratio of intervertebral height were 23.48% ± 5.36%, 2.2° ± 1.1°, 29.4° ± 6.5°, and 0.68 ± 0.21, respectively. Postoperatively, the respective measurements were 6.47% ± 1.49%, 10.3° ± 3.3°, 42.6° ± 8.1°, and 0.85 ± 0.12. No patients experienced major complications. In the SRS group, preoperatively, the average percentile degree of displacement, displacement angle, sacral inclination, and ratio of intervertebral height were 21.78% ± 5.16%, 2.3° ± 1.0°, 26.4° ± 8.5°, and 0.62 ± 0.25, respectively. Postoperatively, the respective measurements were 6.34% ± 2.01%, 9.8° ± 2.1°, 44.1° ± 7.6°, and 0.79 ± 0.23. One patient experienced a badly placed screw in the right pedicle of lumbar 4. CONCLUSIONS: This kind of new fixation system (IBLRFS) was shown to be useful in the treatment of spondylolisthesis, and its use was associated with minimal complications after 14 months of mean follow-up. LEVEL OF EVIDENCE: Therapeutic, case studies (level 4).

[Monitoring retrograde adenoviral transgene expression in spinal cord and anterograde labeling of the peripheral nerves].

OBJECTIVE: Targeted adenoviral gene delivery from peripheral nerves was used to integrally analyse the characterization and time course of LacZ gene (AdLacZ) retrograde transfer to spinal cord and transgene product anterograde labeling of peripheral nerve. METHODS: Recombinant replication-defective adenovirus containing AdLacZ was administrated to the cut proximal stumps of median and tibial nerves in Wistar rats. Then the transected nerve was repaired with 10-0 nylon sutures. At different time point post-infection the spinal cords of C5 to T1 attached with DRGs and brachial plexuses, or L2 to L6 attached with DRGs and lumbosacral plexuses were removed. The removed spinal cord and DRCs were cut into 50 microm serial coronal sections and processed for X-gal staining and immunohistochemical staining. The whole specimens of brachial or lumbosacral plexuses attaching with their peripheral nerves were processed for X-gal staining. The number of X-gal stained neurons was counted and the initial detected time of retrograde labeling, peak time and persisting period of gene expression in DRG sensory neurons, spinal cord motor neurons and peripheral nerves were studied. RESULTS: The gene transfer was specifically targeted to the particular segments of spinal cord and DRGs, and transgene expression was strictly unilaterally corresponding to the infected nerves. Within the same nerve models, the initial detected time of gene expression was earliest in DRG neurons, then in the motor neurons and latest in peripheral nerves. The persisting duration of beta-gal staining was shortest in motor neurons, then in sensory neurons and longest in peripheral nerves. The initial detected time of beta-gal staining in median nerve models was earlier in median nerve models compared with that in the tibial nerve models. Although the initial detected time and the beginning of peak duration of beta-gal staining were not same, the decreasing time of beta-gal staining in motor and sensory neurons of the two nerve models were started at about the same day 8 post-infection. The labeled neurons were more in tibial nerve models than that in median nerve models. Within the same models, the labeled sensory neurons of DRGs were more than labeled motor neurons of ventral horn. The beta-gal staining was tender in median nerves than that in tibial nerves. However the persisting time of beta-gal staining was longer in tibial nerve models. CONCLUSION: The strong gene expression in neurons and PNS renders this system particularly attractive for neuroanatomical tracing studies. Furthermore this gene delivery method allowing specific targeting of motor and sensory neurons without damaging the spinal cord might offer potentialities for the gene therapy of peripheral nerve injury.