A randomized trial of Trendelenburg position for acute moderate ischemic stroke.
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SUBMITTER: Chen HS
PROVIDER: S-EPMC10163013 | biostudies-literature | 2023 May
REPOSITORIES: biostudies-literature
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A randomized trial of Trendelenburg position for acute moderate ischemic stroke.
Chen Hui-Sheng HS Zhang Nan-Nan NN Cui Yu Y Li Xiao-Qiu XQ Zhou Cheng-Shu CS Ma Yu-Tong YT Zhang Hong H Jiang Chang-Hao CH Li Run-Hui RH Wan Li-Shu LS Jiao Zhen Z Xiao Hong-Bo HB Li Zhuo Z Yan Ting-Guang TG Wang Duo-Lao DL Nguyen Thanh N TN
Nature communications 20230505 1
We aim to explore the effect of head-down position (HDP), initiated within 24 hours of onset, in moderate anterior circulation stroke patients with probable large artery atherosclerosis (LAA) etiology. This investigator-initiated, multi-center trial prospective, randomized, open-label, blinded-endpoint, multi-center and phase-2 trial was conducted in China and completed in 2021. Eligible patients were randomly assigned (1:1) into the HDP group receiving -20° Trendelenburg, or control group recei ...[more]
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Project description:BackgroundXingnaojing injection (XNJ) is widely used for the treatment of stroke in China. However, there is currently a lack of high-quality evidence of its efficacy for acute ischemic stroke. The main objective of this study is to determine whether the addition of XNJ to standard care improves the 3-month functional outcome in patients with acute ischemic stroke (AIS).Methods/designThe XMAS study is a multicenter, prospective, randomized controlled, open-label trial with a blinded endpoints design. A total of 720 patients will be randomly allocated to either the intervention or the control group in a 1:1 ratio. The intervention group receives XNJ combined with standard care, and the control group receives standard care alone. XNJ will be administered intravenously every 12 h for 10 days. The primary outcome is the proportion of patients who are independent at 3 months after stroke onset defined as a modified Rankin Scale score of 0 to 2. Secondary outcomes include early neurological deterioration at 48 h, the change in National Institutes of Health Stroke Scale score, patient-reported outcome, symptomatic intracranial hemorrhage at 10 days, the Barthel Index score, deaths from any cause and cardiovascular events at 3 months.DiscussionThe results of this trial will provide critical evidence for XNJ in the treatment of AIS as a complementary approach that can be initiated after reperfusion therapy or when the AIS is not eligible for thrombolytic treatment.Trial registrationClinical Trials.gov, ID: NCT02728180 . Registered on 28 March 2016.
| S-EPMC5644245 | biostudies-literature
Project description:IntroductionTwo pharmacological possibilities exist for an acute ischemic stroke (AIS): recanalization of the occluded artery and neuroprotection from ischaemic injury, the latter's efficacy being debatable. We sought to determine whether administration of Citicoline immediately after recanalization therapy for AIS would improve clinical and radiological outcome at three months compared to standard treatment alone.Patients and methodsCAISR was a single centre, randomized, placebo-controlled, parallel-group trial with blinded endpoint assessment. It was approved by the All India Institute of Medical Sciences Institutional ethics committee and registered at the Clinical Trial Registry of India (CTRI/2018/011900). We recruited participants with AIS undergoing recanalization therapy and randomly assigned them to receive either Citicoline or placebo in 1:1 ratio. Citicoline arm patients received Citicoline 1gm BD intravenously for three days, followed by oral citicoline 1gm BD for 39 days. Placebo arm patients received 100ml intravenous normal saline for three days, followed by multivitamin tablet BD for 39 days. All patients received standard of care.OutcomeBlinded assessors did the follow-up assessment at six weeks (MRI Brain-stroke volume) and three months (NIHSS 0-2, mRS 0-2 and Barthel index> = 95).ResultsThe infarct volume decreased from week 1 to week 6 by 2.6 cm3 on placebo versus 4.2 cm3 on Citicoline (p-0.483). The OR for achieving NIHSS 0-2, mRS 0-2 and Barthel index> = 95 with Citicoline was found to be 0.96(95%CI 0.39-2.40), 0.92(95%CI 0.40-2.05) and 0.87(95%CI 0.22-2.98) respectively.ConclusionCAISR was the first to evaluate the role of Citicoline, when used immediately after recanalization therapy, when the penumbral tissue is the most susceptible either to be protected from injury or become ischemic. We did not find any significant difference between the Citicoline or placebo arms with respect to either our primary or secondary outcomes.
| S-EPMC9154187 | biostudies-literature
Project description:ImportancePreclinical and clinical studies have suggested a neuroprotective effect of remote ischemic conditioning (RIC), which involves repeated occlusion/release cycles on bilateral upper limb arteries; however, robust evidence in patients with ischemic stroke is lacking.ObjectiveTo assess the efficacy of RIC for acute moderate ischemic stroke.Design, setting, and participantsThis multicenter, open-label, blinded-end point, randomized clinical trial including 1893 patients with acute moderate ischemic stroke was conducted at 55 hospitals in China from December 26, 2018, through January 19, 2021, and the date of final follow-up was April 19, 2021.InterventionsEligible patients were randomly assigned within 48 hours after symptom onset to receive treatment with RIC (using a pneumatic electronic device and consisting of 5 cycles of cuff inflation for 5 minutes and deflation for 5 minutes to the bilateral upper limbs to 200 mm Hg) for 10 to 14 days as an adjunct to guideline-based treatment (n = 922) or guideline-based treatment alone (n = 971).Main outcomes and measuresThe primary end point was excellent functional outcome at 90 days, defined as a modified Rankin Scale score of 0 to 1. All end points had blinded assessment and were analyzed on a full analysis set.ResultsAmong 1893 eligible patients with acute moderate ischemic stroke who were randomized (mean [SD] age, 65 [10.3] years; 606 women [34.1%]), 1776 (93.8%) completed the trial. The number with excellent functional outcome at 90 days was 582 (67.4%) in the RIC group and 566 (62.0%) in the control group (risk difference, 5.4% [95% CI, 1.0%-9.9%]; odds ratio, 1.27 [95% CI, 1.05-1.54]; P = .02). The proportion of patients with any adverse events was 6.8% (59/863) in the RIC group and 5.6% (51/913) in the control group.Conclusions and relevanceAmong adults with acute moderate ischemic stroke, treatment with remote ischemic conditioning compared with usual care significantly increased the likelihood of excellent neurologic function at 90 days. However, these findings require replication in another trial before concluding efficacy for this intervention.Trial registrationClinicalTrials.gov Identifier: NCT03740971.
| S-EPMC9382441 | biostudies-literature
Project description:ImportanceDespite some promising preclinical and clinical data, it remains uncertain whether remote ischemic conditioning (RIC) with transient cycles of limb ischemia and reperfusion is an effective treatment for acute stroke.ObjectiveTo evaluate the effect of RIC when initiated in the prehospital setting and continued in the hospital on functional outcome in patients with acute stroke.Design, setting, and participantsThis was a randomized clinical trial conducted at 4 stroke centers in Denmark that included 1500 patients with prehospital stroke symptoms for less than 4 hours (enrolled March 16, 2018, to November 11, 2022; final follow-up, February 3, 2023).InterventionThe intervention was delivered using an inflatable cuff on 1 upper extremity (RIC cuff pressure, ≤200 mm Hg [n = 749] and sham cuff pressure, 20 mm Hg [n = 751]). Each treatment application consisted of 5 cycles of 5 minutes of cuff inflation followed by 5 minutes of cuff deflation. Treatment was started in the ambulance and repeated at least once in the hospital and then twice daily for 7 days among a subset of participants.Main outcomes and measuresThe primary end point was improvement in functional outcome measured as a shift across the modified Rankin Scale (mRS) score (range, 0 [no symptoms] to 6 [death]) at 90 days in the target population with a final diagnosis of ischemic or hemorrhagic stroke.ResultsAmong 1500 patients who were randomized (median age, 71 years; 591 women [41%]), 1433 (96%) completed the trial. Of these, 149 patients (10%) were diagnosed with transient ischemic attack and 382 (27%) with a stroke mimic. In the remaining 902 patients with a target diagnosis of stroke (737 [82%] with ischemic stroke and 165 [18%] with intracerebral hemorrhage), 436 underwent RIC and 466 sham treatment. The median mRS score at 90 days was 2 (IQR, 1-3) in the RIC group and 1 (IQR, 1-3) in the sham group. RIC treatment was not significantly associated with improved functional outcome at 90 days (odds ratio [OR], 0.95; 95% CI, 0.75 to 1.20, P = .67; absolute difference in median mRS score, -1; -1.7 to -0.25). In all randomized patients, there were no significant differences in the number of serious adverse events: 169 patients (23.7%) in the RIC group with 1 or more serious adverse events vs 175 patients (24.3%) in the sham group (OR, 0.97; 95% CI, 0.85 to 1.11; P = .68). Upper extremity pain during treatment and/or skin petechia occurred in 54 (7.2%) in the RIC group and 11 (1.5%) in the sham group.Conclusions and relevanceRIC initiated in the prehospital setting and continued in the hospital did not significantly improve functional outcome at 90 days in patients with acute stroke.Trial registrationClinicalTrials.gov Identifier: NCT03481777.
| S-EPMC10548297 | biostudies-literature
Project description:BackgroundPneumonia is a major risk factor of death after acute stroke. In a mouse model, preventive antibacterial therapy with moxifloxacin not only prevents the development of post-stroke infections, it also reduces mortality, and improves neurological outcome significantly. In this study we investigate whether this approach is effective in stroke patients.MethodsPreventive ANtibacterial THERapy in acute Ischemic Stroke (PANTHERIS) is a randomized, double-blind, placebo-controlled trial in 80 patients with severe, non-lacunar, ischemic stroke (NIHSS>11) in the middle cerebral artery (MCA) territory. Patients received either intravenous moxifloxacin (400 mg daily) or placebo for 5 days starting within 36 hours after stroke onset. Primary endpoint was infection within 11 days. Secondary endpoints included neurological outcome, survival, development of stroke-induced immunodepression, and induction of bacterial resistance.FindingsOn intention-to treat analysis (79 patients), the infection rate at day 11 in the moxifloxacin treated group was 15.4% compared to 32.5% in the placebo treated group (p = 0.114). On per protocol analysis (n = 66), moxifloxacin significantly reduced infection rate from 41.9% to 17.1% (p = 0.032). Stroke associated infections were associated with a lower survival rate. In this study, neurological outcome and survival were not significantly influenced by treatment with moxifloxacin. Frequency of fluoroquinolone resistance in both treatment groups did not differ. On logistic regression analysis, treatment arm as well as the interaction between treatment arm and monocytic HLA-DR expression (a marker for immunodepression) at day 1 after stroke onset was independently and highly predictive for post-stroke infections.InterpretationPANTHERIS suggests that preventive administration of moxifloxacin is superior in reducing infections after severe non-lacunar ischemic stroke compared to placebo. In addition, the results emphasize the pivotal role of immunodepression in developing post-stroke infections.Trial registrationControlled-Trials.com ISRCTN74386719.
| S-EPMC2373885 | biostudies-literature
Project description:BackgroundLaparoscopic surgery has become a standard of care for many gynecological surgeries due to its lower morbidity, pain and cost compared to open techniques. Unfortunately, the use of carbon dioxide (CO2) to insufflate the abdomen is the main contributor to post-operative shoulder pain.MethodsWe aim to assess the effect of postoperative Trendelenburg position on shoulder pain after gynecological laparoscopic procedures. We hypothesize that maintaining the patient in Trendelenburg for 24 h postoperatively will significantly decrease postoperative shoulder pain and analgesic consumption. After obtaining written informed consent, 108 patients were prospectively randomized into two groups. In the control group, patients underwent standard gynecologic laparoscopic procedures; then after passive deflation of the pneumoperitoneum at the end of the surgery, the patients were placed in supine head up position in the post anesthesia care unit (PACU) and received our institution's common postoperative care. Patients in the intervention group were subjected to the same maneuver but were positioned in a Trendelenburg position (20 °) once fully awake and cooperative in the PACU and retained this position for the first 24 h. Numerical rating scale (NRS) was used to assess shoulder pain and nausea upon patient arrival to the PACU, at 4, 6, 12 (primary outcome) and 24 h postoperatively. Time to first rescue pain medication, total rescue pain medications and overall satisfaction with pain control were recorded. 101 patients were included in the final data analysis.ResultsBoth groups were comparable in terms of baseline characteristics. NRS pain scores were significantly lower in the intervention group at 12 h compared to the control group (0 [0-1] versus 5 [1-4], p < 0.001), furthermore improvement in postoperative shoulder pain between time of arrival to PACU (time zero) and 12 h postoperatively was significantly higher in patients allocated to the experimental group compared to the control group. Pain scores were significantly lower in patients allocated to the experimental group versus the control group (0 [0-1] versus 5 [1-4], p < 0.001).ConclusionIn conclusion, Trendelenburg position is an easy non-pharmacologic intervention that is beneficial in reducing postoperative shoulder pain following gynecologic laparoscopic surgery.Trial registrationRetrospectively registered at Clinicaltrials.gov, registration number NCT04129385, date of registration: June 28, 2019.
| S-EPMC6988196 | biostudies-literature
Project description:ObjectiveWe evaluated the effect of 2 doses of natalizumab on functional outcomes in patients with acute ischemic stroke (AIS).MethodsIn this double-blind phase 2b trial, patients with AIS aged 18-80 years with NIH Stroke Scale scores of 5-23 from 53 US and European sites were randomized 1:1:1 to receive a single dose of 300 or 600 mg IV natalizumab or placebo, with randomization stratified by treatment window (≤9 or >9 to ≤24 hours from patient's last known normal state). The primary endpoint was a composite measure of excellent outcome (modified Rankin Scale score ≤1 and Barthel Index score ≥95) at day 90 assessed in all patients receiving a full dose. Sample size was estimated from a Bayesian model; p values were not used for hypothesis testing.ResultsAn excellent outcome was less likely with natalizumab than with placebo (natalizumab 300 or 600 mg odds ratio 0.60; 95% confidence interval 0.39-0.93). There was no effect modification by time to treatment or use of thrombolysis/thrombectomy. For natalizumab 300 mg, 600 mg, or placebo, there were no differences in incidence of adverse events (90.0%, 92.1%, and 92.3%, respectively), serious adverse events (25.6%, 32.6%, and 20.9%, respectively), or deaths (6.7%, 4.5%, and 5.5%, respectively).ConclusionsNatalizumab administered ≤24 hours after AIS did not improve patient outcomes.Clinicaltrialsgov identifierNCT02730455 CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that for patients with AIS, an excellent outcome was less likely in patients treated with natalizumab than with placebo.
| S-EPMC7668547 | biostudies-literature
Project description:RationaleEarly neurological deterioration (END) within 72 h of stroke onset is associated with poor prognosis. Optimizing hydration might reduce the risk of END.AimsThis study aimed to determine in acute ischemic stroke patients if enhanced hydration versus standard hydration reduced the incidence of major (primary) and minor (secondary) END, as well as whether it increased the incidence of early neurological improvement (secondary), at 72 h after admission.Sample size estimateA total of 244 participants per arm.Methods and designA prospective, double-blinded, multicenter, parallel-group, randomized controlled trial conducted at four hospitals from April 2014 to July 2020, with data analyzed in August 2020. The sample size estimated was 488 participants (244 per arm). Ischemic stroke patients with measurable neurological deficits of onset within 12 h of emergency department presentation and blood urea nitrogen/creatinine (BUN/Cr) ratio ⩾ 15 at point of admission were enrolled and randomized to 0.9% sodium chloride infusions of varying rates-enhanced hydration (20 mL/kg body weight, one-third given via bolus and remainder over 8 h) versus standard hydration (60 mL/h for 8 h), followed by maintenance infusion of 40-80 mL/h for the subsequent 64 h. The primary outcome measure was the incidence of major END at 72 h after admission, defined as an increase in National Institutes of Health Stroke Scale of ⩾ 4 points from baseline.ResultsOverall, 487 participants were randomized (median age 67 years; 287 females). At 72 h, 7 (2.9%) in the enhanced hydration arm and 5 (2.0%) in the standard hydration developed major END (p = 0.54). The incidence of minor END and early neurological improvement did not differ between treatment arms.Conclusion and relevanceEnhanced hydration did not reduce END or improve short-term outcomes in acute ischemic stroke.Trial registrationClinicalTrials.gov (NCT02099383, https://clinicaltrials.gov/study/NCT02099383).
| S-EPMC11528967 | biostudies-literature
Project description:Delirium is the most common postsurgical neurological complication and has a variable incidence rate. Laparoscopic surgery, when associated with the Trendelenburg position, can cause innumerable physiological changes and increase the risk of neurocognitive changes. The association of general anesthesia with a spinal block allows the use of lower doses of anesthetic agents for anesthesia maintenance and facilitates better control over postoperative pain. Our primary outcome was to assess whether a spinal block influences the incidence of delirium in oncologic patients following laparoscopic surgery in the Trendelenburg position. Our secondary outcome was to analyze whether there were other associated factors. A total of 150 oncologic patients who underwent elective laparoscopic surgeries in the Trendelenburg position were included in this randomized controlled trial. The patients were randomized into 2 groups: the general anesthesia group and the general anesthesia plus spinal block group. Patients were immediately evaluated during the postoperative period and monitored until they were discharged, to rule out the presence of delirium. Delirium occurred in 29 patients in total (22.3%) (general anesthesia group: 30.8%; general anesthesia plus spinal block: 13.8% p = 0.035). Patients who received general anesthesia had a higher risk of delirium than patients who received general anesthesia associated with a spinal block (odds ratio = 3.4; 95% confidence interval: 1.2-9.6; p = 0.020). Spinal block was associated with reduced delirium incidence in oncologic patients who underwent elective laparoscopic surgeries in the Trendelenburg position.
| S-EPMC8128254 | biostudies-literature
Project description:BackgroundAcute ischemic stroke (AIS) complicating an acute myocardial infarction (AMI) is not uncommon, but can severely worsen the clinical prognosis. This study aimed to investigate whether remote ischemic conditioning (RIC) could provide clinical benefits to patients with AIS complicating AMI.MethodsSubjects with AIS complicating AMI were recruited in this double-blind, randomized, controlled trial; assigned to the RIC and sham groups; and respectively underwent twice daily RIC and sham RIC for 2 weeks. All subjects received standard medical therapy. The primary endpoint was the rate of major adverse cardiac and cerebrovascular events (MACCEs) within 3 months after enrollment. MACCEs comprise of death from all causes, unstable anginas, AMI, acute ischemic strokes, and transient ischemic attacks.ResultsEighty subjects were randomly assigned; 37 patients in the RIC group and 40 patients in the sham-RIC group completed the 3-month follow-up and were included in the final analysis. Both RIC and sham RIC procedures were well tolerated. At 3-month follow-up, 11 subjects (29.7%) in the RIC group experienced MACCEs compared to 21 (52.5%) in the sham group (hazard ratio [HR], 0.396; 95% confidence interval, 0.187-0.838; adjusted p < 0.05). Six subjects (16.2%) in the RIC group had died at the 3-month follow up, significantly lower than the 15 (37.5%) deaths in the sham group (adjusted HR 0.333; 95% CI 0.126-0.881; p = 0.027). Seventeen subjects (45.9%) in the RIC group and 6 subjects (15.0%) in the sham group achieved functional independence (mRS score ≤ 2) at 3-month follow-up (adjusted OR 12.75; 95% CI 2.104-77.21; p = 0.006).ConclusionsAmong patients with acute ischemic stroke complicating acute myocardial infarction, treatment with remote ischemic conditioning decreased the major adverse cardiac and cerebrovascular events and improved functional outcomes at 90 days.Trial registrationURL: www.Clinicaltrialsgov . Unique identifier: NCT03868007. Registered 8 March 2019.
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