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Objectives: Saline and Plasma-Lyte have different physiochemical contents; consequently, they may differently affect patients' renal function. We compared the effects of fluid therapy with 0.9% saline and with Plasma-Lyte 148 on renal function as assessed by creatinine concentration among patients undergoing major surgery. Methods: We conducted a prospective, double-blinded cluster crossover trial comparing the effects of the two fluids on major surgery patients. The primary aim was to establish the pilot feasibility, safety and preliminary efficacy evidence base for a large interventional trial to establish whether saline or Plasma-Lyte is the preferred crystalloid fluid for managing major surgery patients. The primary efficacy outcome was the proportion of patients with changes in renal function as assessed by creatinine concentration during their index hospital admission. We used changes in creatinine to define acute kidney injury (AKI) according to the RIFLE criteria. Results: The study was feasible with 100% patient and clinician acceptance. There were no deviations from the trial protocol. After screening, we allocated 602 patients to saline and 458 to Plasma-Lyte. The median (IQR) volume of intraoperative fluid received was 2000 mL (1000:2000) in both groups. Forty-nine saline patients (8.1%) and 49 Plasma-Lyte patients (10.7%) developed a postoperative AKI (adjusted incidence rate ratio [aIRR]: 1.34; 95% CI: 0.93–1.95; p = 0.120). No differences were observed in the development of postoperative complications (aIRR: 0.98; 95% CI: 0.89–1.08) or the severity of the worst complication (aIRR: 1.00; 95% CI: 0.78–1.30). The median (IQR) length of hospital stay was six days (3:11) for the saline group and five days (3:10) for the Plasma-Lyte group (aIRR: 0.85; 95% CI: 0.73–0.98). There were no serious adverse events relating to the trial fluids, nor were there fluid crossover or contamination events. Conclusions: The study design was feasible to support a future follow-up larger clinical trial. Patients treated with saline did not demonstrate an increased incidence of postoperative AKI (defined as changes in creatinine) compared to those treated with Plasma-Lyte. Our findings imply that clinicians can reasonably use either solution intraoperatively for adult patients undergoing major surgery. Trial registration: Registry: Australian New Zealand Clinical Trials Registry; ACTRN12613001042730; URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=364988. [ABSTRACT FROM AUTHOR]

Background: Pre-existing comorbidities can compromise recovery post-stroke. However, the association between comorbidity burden and patient-rated perceived impact has not been systematically investigated. To date, only observer-rated outcome measures of function, disability, and dependence have been used, despite the complexity of the impact of stroke on an individual. Aim: Our aim was to explore the association between comorbidity burden and patient-rated perceived impact and overall recovery, within the first-year post-stroke, after adjusting for stroke severity, age, and sex. Methods: The sample comprised 177 stroke survivors from 18 hospitals throughout Australia and New Zealand. Comorbidity burden was calculated using the Charlson Comorbidity Index. Perceived impact and recovery were measured by the Stroke Impact Scale index and Stroke Impact Scale overall recovery scale. Quantile regression models were applied to investigate the association between comorbidity burden and perceived impact and recovery. Results: Significant negative associations between the Charlson Comorbidity Index and the Stroke Impact Scale index were found at three months. At the.25 quantile, a one-point increase on the Charlson Comorbidity Index was associated with 6.80-points decrease on the Stroke Impact Scale index (95%CI: −11.26, −2.34; p =.003). At the median and.75 quantile, a one-point increase on the Charlson Comorbidity Index was associated, respectively, with 3.58-points decrease (95%CI: −5.62, −1.54; p =.001) and 1.76-points decrease (95%CI: −2.80, −0.73; p =.001) on the Stroke Impact Scale index. At 12 months, at the.25 and.75 quantiles, a one-point increase on the Charlson Comorbidity Index was associated, respectively, with 6.47-points decrease (95%CI: −11.05, −1.89; p =.006) and 1.26-points decrease (95%CI: −2.11, −0.42; p =.004) on the Stroke Impact Scale index. For the Stroke Impact Scale overall recovery measure, significant negative associations were found only at the median at three months and at the.75 quantile at 12 months. Conclusion: Comorbidity burden is independently associated with patient-rated perceived impact within the first-year post-stroke. The addition of patient-rated impact measures in personalized rehabilitation may enhance the use of conventional observer-rated outcome measures. [ABSTRACT FROM AUTHOR]

Background: Older people are often admitted for rehabilitation to improve walking, yet not everyone improves. The aim of this study was to determine key factors associated with a positive response to hospital-based rehabilitation in older people.Methods: This was a secondary data analysis from a multisite randomized controlled trial. Older people (n= 198, median age 80.9 years, IQR 76.6- 87.2) who were admitted to geriatric rehabilitation wards with a goal to improve walking were recruited. Participants were randomized to receive additional daily physical therapy focused on mobility (n = 99), or additional social activities (n = 99). Self-selected gait speed was measured on admission and discharge. Four participants withdrew. People who changed gait speed ≥0.1 m/s were classified as 'responders' (n = 130); those that changed <0.1m/s were classified as 'non-responders' (n = 64). Multivariable logistic regression explored the association of six pre-selected participant factors (age, baseline ambulation status, frailty, co-morbidities, cognition, depression) and two therapy factors (daily supervised upright activity time, rehabilitation days) and response.Results: Responding to rehabilitation was associated with the number of days in rehabilitation (OR 1.04; 95% CI 1.00 to 1.08; p = .039) and higher Mini Mental State Examination scores (OR 1.07, 95% CI 1.00 - 1.14; p = .048). No other factors were found to have association with responding to rehabilitation.Conclusion: In older people with complex health problems or multi-morbidities, better cognition and a longer stay in rehabilitation were associated with a positive improvement in walking speed. Further research to explore who best responds to hospital-based rehabilitation and what interventions improve rehabilitation outcomes is warranted.Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12613000884707; ClinicalTrials.gov Identifier NCT01910740 . [ABSTRACT FROM AUTHOR]

A patient's death can pose significant stress on the family and the treating anaesthetist. Anaesthetists' attitudes about the benefits of and barriers to attending a patient's funeral are unknown. Therefore, we performed a prospective, cross-sectional study to ascertain the frequency of anaesthetists' attendance at a patient's funeral and their perceptions about the benefits and barriers. The primary aim was to investigate the attitudes of anaesthetists towards attending the funeral of a patient. The secondary aims were to examine the perceived benefits of and barriers to attending the funeral and to explore the rate of bonds being formed between anaesthetists, patients and families. Of the 424 anaesthetists who completed the survey (response rate 21.2%), 25 (5.9%) had attended a patient's funeral. Of the participants, 364 (85.9%) rarely formed special bonds with patients or their families; 233 (55%) believed that forming a special bond would increase the likelihood of their attendance. Showing respect to patients or their families was the most commonly perceived benefit of attending a funeral. Participants found expression of personal grief and caring for the patient at the end-of-life and beyond beneficial to themselves and the family. Fear of their attendance being misinterpreted or perceived as not warranted by the family as well as time restraints were barriers for their attendance. Most anaesthetists had never attended a patient's funeral. Few anaesthetists form close relationships with patients or their families. Respect, expression of grief and caring beyond life were perceived benefits of attendance. Families misinterpreting the purpose of attendance or not expecting their attendance and time restraints were commonly perceived barriers. Trial registration:ACTRN 12618000503224. [ABSTRACT FROM AUTHOR]

Background: The utility-weighted modified Rankin Scale (UW-mRS) is an outcome measure recently proposed to improve statistical efficiency and interpretability of the mRS. Statistical properties of the UW-mRS have been well investigated, but construct validity has yet to be established. Aims: To investigate the construct validity of the UW-mRS as a primary outcome measure by assessing variability in utility values within and between mRS categories, over time post-stroke, and by different derivation methods. Methods: UW-mRS was derived using assessment of quality of life (AQoL-4D) and mRS scores at 3 and 12 months (n = 2030) from a large randomized controlled trial, A Very Early Rehabilitation Trial (AVERT). Receiver operator characteristic (ROC) analysis of AQoL-4D was conducted to differentiate between sequential mRS categories. Intraclass correlation was used to explore variability in utility values over time post-stroke, UW-mRS values, and derivation methods from multiple studies. Results: UW-mRS values for mRS categories 0–6 at three months were 0.80, 0.78, 0.63, 0.37, 0.11, 0.03, and 0. Based on AQoL-4D utility values, areas under the ROC curve varied from 0.54 to 0.87. Time post-stroke explained 42%–56% of variability in AQoL-4D utility values in patients with no change in mRS between 3 and 12 months. The choice of the derivation method contributed to 25% of the variability in UW-mRS values. Conclusions: The high variability in utility values between and within mRS categories, over time post-stroke, and using different derivation methods is not adequately reflected in the UW-mRS. These threats to construct validity warrant caution when using UW-mRS as a primary outcome measure. Trial registration: Australian New Zealand Clinical Trials Registry (ACTRN12606000185561). [ABSTRACT FROM AUTHOR]

Background Endovascular thrombectomy (ET) is safe, effective, and cost-effective for large artery occlusion ischemic stroke, even if under different selection criteria. Purpose To study the preferences for ET selection criteria by surveying clinicians and consumers, where number needed to treat to achieve functional independence is the only factor being considered. Methods A survey providing visual representation of the proportion of patients treated and expected functional outcomes, based on the selection criteria in each of the recent randomized trials of ET, was distributed nationwide in Australia and New Zealand to clinicians and consumers. The preferred selection criteria were identified by the frequency of first choice and using decision-analysis techniques to assess consensus by treating respondents as a panel of experts and aggregating their preferences on selection criteria. Results 104 clinicians and 107 consumer respondents (43/107 (40%) stroke survivors) took part in the study. Selection criteria of EXTEND-IA were ranked as the most preferred by the consensus process analysis and were the first choice of 64 individual clinicians (61.5%; 95% CI 52% to 71%). ESCAPE trial selection criteria were ranked as the most preferred option and chosen by 42 individual consumers (39%; 95% CI 29% to 48%). Most clinicians based their choice on the ratio of patients benefiting from ET, while consumers considered the absolute number of patients benefiting. Conclusions Consumers favor maximization of the absolute number achieving good outcome in comparison with clinicians. This finding suggests that less restrictive criteria may be favored in clinical practice. [ABSTRACT FROM AUTHOR]

Background: Loss of hand function is one of the most devastating consequences of spinal cord injury. Intensive hand training provided on an instrumented exercise workstation in conjunction with functional electrical stimulation may enhance neural recovery and hand function. The aim of this trial is to compare usual care with an 8-week program of intensive hand training and functional electrical stimulation.Methods/design: A multicentre randomised controlled trial will be undertaken. Seventy-eight participants with recent tetraplegia (C2 to T1 motor complete or incomplete) undergoing inpatient rehabilitation will be recruited from seven spinal cord injury units in Australia and New Zealand and will be randomised to a control or experimental group. Control participants will receive usual care. Experimental participants will receive usual care and an 8-week program of intensive unilateral hand training using an instrumented exercise workstation and functional electrical stimulation. Participants will drive the functional electrical stimulation of their target hands via a behind-the-ear bluetooth device, which is sensitive to tooth clicks. The bluetooth device will enable the use of various manipulanda to practice functional activities embedded within computer-based games and activities. Training will be provided for one hour, 5 days per week, during the 8-week intervention period. The primary outcome is the Action Research Arm Test. Secondary outcomes include measurements of strength, sensation, function, quality of life and cost effectiveness. All outcomes will be taken at baseline, 8 weeks, 6 months and 12 months by assessors blinded to group allocation. Recruitment commenced in December 2009.Discussion: The results of this trial will determine the effectiveness of an 8-week program of intensive hand training with functional electrical stimulation.Trial Registration: NCT01086930 (12th March 2010)ACTRN12609000695202 (12th August 2009). [ABSTRACT FROM AUTHOR]

Background: The endothelial glycocalyx, a carbohydrate-rich layer coating all endothelial surfaces, plays a fundamental role in the function of microcirculation. The primary aim of this study was to evaluate the feasibility of using dexamethasone and albumin to protect the endothelial glycocalyx in patients undergoing abdominal surgery. Secondary and exploratory outcomes included efficacy and safety., Methods: We conducted a multicenter, open-label, blinded end point, phase 2, randomized trial. Patients undergoing colorectal, pancreas, or liver surgery were recruited and randomized to receive either intravenous dexamethasone (16 mg) and 20% albumin (100 mL) at induction of anesthesia, then 200 mL of 20% albumin with each subsequent 1000 mL of crystalloid administered (dexamethasone and albumin [Dex-Alb] group), or crystalloid fluid only with no dexamethasone (control group). Feasibility end points included patient recruitment and retention, consent rate, and successful study drug administration. The primary efficacy end point was the measurement of plasma syndecan-1 level on postoperative day (POD) 1, and secondary end points were heparan sulfate levels and inflammatory markers measured at 4 perioperative timepoints. Safety end points included errors in administration of the intervention, hyperglycemia, occurrence of postoperative complications, and patient retention., Results: Seventy-two patients were randomized. All feasibility end points were achievable. There were no statistically significant differences observed in median (interquartile range) syndecan-1 levels on POD 1 (39 ng·mL-1 [20-97] in the Dex-Alb group versus 41 ng·mL-1 [19-84] in the control group; difference in medians -2.1, 95% confidence interval [CI], -13 to 8.6; P = .69). The Dex-Alb group had lower POD 1 heparan sulfate levels (319 ng·mL-1 [161-717] in the Dex-Alb group versus 1422 [670-2430] ng·mL-1 in the control group; difference in medians -1085, 95% CI, -1779 to -391) and C-reactive protein (CRP) levels on POD 1 (48 [29-77] mg·L-1 in the Dex-Alb group versus 85 mg·L-1 [49-133] in the control group; difference in medians -48, 95% CI, -75 to -21). Fewer patients had one or more postoperative complication in the Dex-Alb group than in the control group (6 [17%] vs 18 patients [50%]; odds ratio = 0.2, 95% CI, 0.06-0.6)., Conclusions: Intravenous dexamethasone and albumin administration was feasible but did not reduce syndecan-1 on POD 1 in patients undergoing abdominal surgery. Given the clinically important CIs observed between the groups for heparan sulfate, CRP, and postoperative complications, a larger trial assessing the associations between dexamethasone and albumin administration and these outcomes is warranted., Competing Interests: Conflicts of Interest: See Disclosures at the end of the article., (Copyright © 2021 International Anesthesia Research Society.)

Aims: Pre-diabetes is a common condition that affects about 16.4% of Australian adults. Hyperglycaemia is a strong risk factor for the development of stroke. Metformin XR is an approved medication to treat type 2 diabetes in Australia but not pre-diabetes. Additionally, whether it is tolerated following a stroke is unclear. In this pilot study, we aimed to assess the feasibility of Metformin XR in people with stroke and pre-diabetes., Methods: In this PROBE design trial, people who had recent stroke (within 3 months) with pre-diabetes were randomized to either the active arm (n = 13) receiving usual care plus Metformin XR (500 mg daily increased to a total daily dose of 1500 mg) or the control group receiving only usual care (n = 13). At baseline & after four months of intervention, clinical and biomedical characteristics, cardiovascular risk factors and medication data were recorded. At one month and 2.5 months into the study, compliance rateandside effects were determined., Results: This trial showed that it is feasible to recruit, retain and monitor participants. However, the compliance rate was low. Adherence to metformin XR was 52% (IQR:42% to 61%) based on the remaining tablets in the container after 4 months of intervention. None of the reported side effects were deemed to be related to the study treatment and no significant differences were observed between the metformin XR and the control group., Conclusion: Treatment with Metformin XR in participants admitted with stroke and with pre-diabetes is feasible and safe. Strategies are needed to improve adherence in future trials., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Background and hypothesis Intravenous thrombolysis with alteplase remains standard care prior to thrombectomy for eligible patients within 4.5 h of ischemic stroke onset. However, alteplase only succeeds in reperfusing large vessel arterial occlusion prior to thrombectomy in a minority of patients. We hypothesized that tenecteplase is non-inferior to alteplase in achieving reperfusion at initial angiogram, when administered within 4.5 h of ischemic stroke onset, in patients planned to undergo endovascular therapy. Study design EXTEND-IA TNK is an investigator-initiated, phase II, multicenter, prospective, randomized, open-label, blinded-endpoint non-inferiority study. Eligibility requires a diagnosis of ischemic stroke within 4.5 h of stroke onset, pre-stroke modified Rankin Scale≤3 (no upper age limit), large vessel occlusion (internal carotid, basilar, or middle cerebral artery) on multimodal computed tomography and absence of contraindications to intravenous thrombolysis. Patients are randomized to either IV alteplase (0.9 mg/kg, max 90 mg) or tenecteplase (0.25 mg/kg, max 25 mg) prior to thrombectomy. Study outcomes The primary outcome measure is reperfusion on the initial catheter angiogram, assessed as modified treatment in cerebral infarction 2 b/3 or the absence of retrievable thrombus. Secondary outcomes include modified Rankin Scale at day 90 and favorable clinical response (reduction in National Institutes of Health Stroke Scale by ≥8 points or reaching 0-1) at day 3. Safety outcomes are death and symptomatic intracerebral hemorrhage. Trial registration ClinicalTrials.gov NCT02388061.

Background: Spinal cord injury (SCI) leads to a profound muscular atrophy, bone loss and bone fragility. While there is evidence that exercising paralysed muscles may lead to reversal of muscle atrophy in the chronic period after SCI, there is little evidence that exercise can prevent muscle changes early after injury. Moreover, whether exercise can prevent bone loss and microarchitectural decay is not clear., Methods/design: A multi-centre, parallel group, assessor-blinded randomised controlled trial will be conducted. Fifty participants with acute spinal cord injury will be recruited from four SCI units in Australia and New Zealand. Participants will be stratified by site and AIS status and randomised to an experimental or control group. Experimental participants will receive a 12-week programme of functional electrical stimulation (FES)-assisted cycling. Control participants will receive a 12-week programme of passive cycling. The primary outcome is muscle cross-sectional area of the thigh and calf measured using magnetic resonance images (MRI) of the leg. Secondary outcomes include serum biomarkers of SCI osteoporosis (sclerostin, P1NP and β-CTX), markers of immune function (IL-6, IL-10, FGF2, INF-γ, TNF-α), neurological function, body composition, depression and quality of life. Leg MRIs will be measured by a single blinded assessor based in Melbourne. Serum samples will be analysed in a central laboratory. All other characteristics will be measured at baseline and 12 weeks by blinded and trained assessors at each site. The first participant was randomised on 27 November 2012., Discussion: The results of this trial will determine the relative effectiveness of a 12-week programme of FES-assisted cycling versus passive cycling in preventing muscle atrophy and maintaining skeletal integrity after spinal cord injury., Trial Registration: ACTRN12611001079932 (18 October 2011).

Background: Rehabilitation after spinal cord injury (SCI) has traditionally involved teaching compensatory strategies for identified impairments and deficits in order to improve functional independence. There is some evidence that regular and intensive activity-based therapies, directed at activation of the paralyzed extremities, promotes neurological improvement. The aim of this study is to compare the effects of a 12-week intensive activity-based therapy program for the whole body with a program of upper body exercise., Methods/design: A multicenter, parallel group, assessor-blinded randomized controlled trial will be conducted. One hundred eighty-eight participants with spinal cord injury, who have completed their primary rehabilitation at least 6 months prior, will be recruited from five SCI units in Australia and New Zealand. Participants will be randomized to an experimental or control group. Experimental participants will receive a 12-week program of intensive exercise for the whole body, including locomotor training, trunk exercises and functional electrical stimulation-assisted cycling. Control participants will receive a 12-week intensive upper body exercise program. The primary outcome is the American Spinal Injuries Association (ASIA) Motor Score. Secondary outcomes include measurements of sensation, function, pain, psychological measures, quality of life and cost effectiveness. All outcomes will be measured at baseline, 12 weeks, 6 months and 12 months by blinded assessors. Recruitment commenced in January 2011., Discussion: The results of this trial will determine the effectiveness of a 12-week program of intensive exercise for the whole body in improving neurological recovery after spinal cord injury., Trial Registration: NCT01236976 (10 November 2010), ACTRN12610000498099 (17 June 2010).