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Glucose Regulation in Acute Stroke Patients (GRASP) trial: a randomized pilot trial.

ABSTRACT: Hyperglycemia is associated with worse outcome in patients with acute stroke.We conducted a prospective, randomized, multicenter, 3-arm trial (tight control [target 70 to 110 mg/dL], loose control [target 70 to 200 mg/dL], and control usual care [70 to 300 mg/dL]) to assess the feasibility and safety of 2 insulin infusion protocol targets in patients with acute ischemic stroke. The planned sample was 72 subjects.A total of 74 subjects were enrolled. Seventy-two (97%) had data available for the primary analyses and 73 (99%) had 3-month clinical outcome data. Median age was 67 years, median National Institutes of Health Stroke Scale score was 8, median glucose was 163 mg/dL, and median time to randomization was 10.7 hours. Fifty-nine percent of patients were diabetic, 35% received thrombolysis, and 14% of subjects died within 3 months. The loose control and usual care groups had median glucose concentrations of 151 mg/dL. The tight control group had a median glucose concentration of 111 mg/dL. The loose control group spent 90% of the first 24 hours in target and the tight group 44% of time in target. There was only one symptomatic patient with hypoglycemia in the loose control group (4%) and zero in the tight control group. The overall rates of hypoglycemia (<55 mg/dL) were 4% in control, 4% in loose, and 30% in tight. Exploratory efficacy analysis was conducted.Insulin infusion for patients with acute ischemic stroke is feasible and safe using the insulin infusion protocol in the Glucose Regulation in Acute Stroke Patients (GRASP) trial. Exploratory efficacy analysis supports further comparative study.

SUBMITTER: Johnston KC

PROVIDER: S-EPMC2790382 | biostudies-literature | 2009 Dec

REPOSITORIES: biostudies-literature

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Glucose Regulation in Acute Stroke Patients (GRASP) trial: a randomized pilot trial.

Johnston Karen C KC Hall Christiana E CE Kissela Brett M BM Bleck Thomas P TP Conaway Mark R MR

Stroke 20091015 12

<h4>Background and purpose</h4>Hyperglycemia is associated with worse outcome in patients with acute stroke.<h4>Methods</h4>We conducted a prospective, randomized, multicenter, 3-arm trial (tight control [target 70 to 110 mg/dL], loose control [target 70 to 200 mg/dL], and control usual care [70 to 300 mg/dL]) to assess the feasibility and safety of 2 insulin infusion protocol targets in patients with acute ischemic stroke. The planned sample was 72 subjects.<h4>Results</h4>A total of 74 subject ...[more]

PMID: 19834016

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Project description:Background and Aim: Remote ischemic conditioning is a procedure purported to reduce the ischemic injury of an organ. This study aimed to explore the efficiency and safety of remote ischemic conditioning in patients with acute ischemic stroke. We hypothesized that remote ischemic conditioning administered from the first day of hospital admission would improve the infarct volume and clinical outcome at 180 days. Material and Methods: We performed a unicentric double-blind randomized controlled trial. We included all patients consecutively admitted to an Emergency Neurology Department with acute ischemic stroke, ineligible for reperfusion treatment, up to 24 hours from onset. All subjects were assigned to receive secondary stroke prevention treatment along with remote ischemic conditioning on the non-paretic upper limb during the first 5 days of hospitalization, twice daily - a blood pressure cuff placed around the arm was inflated to 20 mmHg above the systolic blood pressure (up to 180 mmHg) in the experimental group and 30 mmHg in the sham group. The primary outcome was the difference in infarct volume (measured on brain CT scan) at 180 days compared to baseline, whereas the secondary outcomes included differences in clinical scores (NIHSS, mRS, IADL, ADL) and cognitive/mood changes (MoCA, PHQ-9) at 180 days compared to baseline. Results: We enrolled 40 patients; the mean age was 65 years and 60% were men. Subjects in the interventional group had slightly better recovery in terms of disability, as demonstrated by the differences in disability scores between admission and 6 months (e.g., the median difference score for Barthel was -10 in the sham group and -17.5 in the interventional group, for ADL -2 in the sham group and -2.5 in the interventional group), as well as cognitive performance (the median difference score for MoCA was -2 in the sham group and -3 in the interventional group), but none of these differences reached statistical significance. The severity of symptoms (median difference score for NIHSS = 5 for both groups) and depression rate (median difference score for PHQ-9 = 0 for both groups) were similar in the two groups. The median difference between baseline infarct volume and final infarct volume at 6 months was slightly larger in the sham group compared to the interventional group (p = 0.4), probably due to an initial larger infarct volume in the former. Conclusion: Our results suggest that remote ischemic conditioning might improve disability and cognition. The difference between baseline infarct volume and final infarct volume at 180 days was slightly larger in the sham group.

Project description:BackgroundThis feasibility study is intended to assess the acceptability of home-based task-specific reach-to-grasp (RTG) training for people with stroke, and to gather data to inform recruitment, retention, and sample size for a definitive randomized controlled trial.Methods/designThis is to be a randomized controlled feasibility trial recruiting 50 individuals with upper-limb motor impairment after stroke. Participants will be recruited after discharge from hospital and up to 12 months post-stroke from hospital stroke services and community therapy-provider services. Participants will be assessed at baseline, and then electronically randomized and allocated to group by minimization, based on the time post-stroke and extent of upper-limb impairment. The intervention group will receive 14 training sessions, each 1 hour long, with a physiotherapist over 6 weeks and will be encouraged to practice independently for 1 hour/day to give a total of 56 hours of training time per participant. Participants allocated to the control group will receive arm therapy in accordance with usual care. Participants will be measured at 7 weeks post-randomization, and followed-up at 3 and 6 months post-randomization. Primary outcome measures for assessment of arm function are the Action Research Arm Test (ARAT) and Wolf Motor Function Test (WMFT). Secondary measures are the Motor Activity Log, Stroke Impact Scale, Carer Strain Index, and health and social care resource use. All assessments will be conducted by a trained assessor blinded to treatment allocation. Recruitment, adherence, withdrawals, adverse events (AEs), and completeness of data will be recorded and reported.DiscussionThis study will determine the acceptability of the intervention, the characteristics of the population recruited, recruitment and retention rates, descriptive statistics of outcomes, and incidence of AEs. It will provide the information needed for planning a definitive trial to test home-based RTG training.Trial registration isrctnISRCTN56716589.

Project description:BACKGROUND:The purpose of this study was to examine the relationships between glucose parameters obtained by continuous glucose monitoring and clinical outcomes in acute stroke patients. METHODS AND RESULTS:Consecutive patients with acute ischemic stroke or intracerebral hemorrhage within 24 hours after onset were included. A continuous glucose monitoring device (iPro2) was attached for the initial 72 hours after emergent admission. Eight glucose parameters were obtained from continuous glucose monitoring: maximum, minimum, mean, and SD of blood glucose levels, as well as area under the curve more than 8 mmol/L of blood glucose, distribution time more than 8 mmol/L of blood glucose, coefficient of variation (%CV), and presence of time less than 4 mmol/L over 72 hours. The primary outcome measure was death or dependency at 3 months (modified Rankin Scale score ?3). One hundred patients with acute ischemic stroke (n=58) or intracerebral hemorrhage (n=42) were included. Blood glucose levels varied between 5.2±1.4 and 11.4±3.2 mmol/L over 72 hours, with area under the curve more than 8 mmol/L of blood glucose of 0.7±1.4 min×mmol/L, distribution time more than 8 mmol/L of blood glucose of 31.7±32.7%, coefficient of variation of 15.5±5.4%, and presence of hypoglycemia in 20% of overall patients. Mean glucose level (adjusted odds ratio, 1.60, 95% confidence interval, 1.12-2.28/1 mmol/L), area under the curve more than 8 mmol/L of blood glucose (2.13, 1.12-4.02/1 min×mmol/L), and distribution time more than 8 mmol/L of blood glucose (1.25, 1.05-1.50/10%) were related to death or dependency for overall patients, as well as for acute ischemic stroke patients (2.05, 1.15-3.65; 2.38, 1.04-5.44; 1.85, 1.10-3.10, respectively). CONCLUSIONS:High mean glucose levels, distribution time more than 8 mmol/L of blood glucose, and areas under the curve more than 8 mmol/L of blood glucose during the initial 72 hours of acute stroke were associated with death or dependency at 3 months.

Project description:IntroductionHyperglycemia is common in acute ischemic stroke and is associated with larger infarct volume and unfavorable functional outcome, also in patients who undergo reperfusion therapy. Hyperglycemia during reperfusion may be a therapeutic target. However, previous randomized trials on the effect of glucose lowering in the acute phase of ischemic stroke failed to demonstrate effects on clinical outcome. Inaccurate glucose measurements and not focussing on patients who undergo reperfusion therapy are possible explanations. Our aim was to study the feasibility and accuracy of continuous glucose monitoring (CGM) in patients with acute ischemic stroke undergoing endovascular treatment (EVT).MethodsAll consecutive patients with ischemic stroke and large vessel occlusion (LVO) of the anterior circulation who were eligible for endovascular therapy within 24 hours of symptom onset and presenting at the emergency department of Isala Hospital Zwolle, the Netherlands, were enrolled in this study. CGM was performed using a Freestyle Libre Flash 2 device (FSL-CGM, Abbot Diabetes Care, Alameda, California, USA) which was implanted on arrival at the emergency department. Feasibility was defined as the number of patients who could be registered for 24 hours and delay in door-to-groin time because of sensor implantation. Accuracy of CGM versus capillary and venous based plasma glucose values was determined with the Parkes error grid analysis.ResultsTwenty-three patients were included of whom 20 completed 24 hours monitoring (87%). One patient did not give permission to use the data; one sensor broke during implantation and one meter was broken after a sensor was shot in so no measurements could be recorded. There was no significant delay in treatment due to implantation of the sensor and no adverse events. One hundred percent of CGM data are in zones A and B of the Parkes error grid analysis so data out of the sensor can be interpreted as accurate.ConclusionIn this study, we showed that continuous glucose monitoring in patients with acute ischemic stroke due to large vessel occlusion of the anterior circulation in patients who were treated with endovascular therapy is feasible, safe and accurate.

Project description:BACKGROUND:Current evidence for the effectiveness of post-stroke cognitive rehabilitation is weak, possibly due to two reasons. First, patients typically express cognitive deficits in several domains. Therapies focusing on specific cognitive deficits might not address their interrelated neurological nature. Second, co-occurring psychological problems are often neglected or not diagnosed, although post-stroke depression is common and related to cognitive deficits. This pilot trial aims to test a rehabilitation program in virtual reality that trains various cognitive domains in conjunction, by adapting to the patient's disability and while investigating the influence of comorbidities. METHODS:Thirty community-dwelling stroke patients at the chronic stage and suffering from cognitive impairment performed 30?min of daily training for 6 weeks. The experimental group followed, so called, adaptive conjunctive cognitive training (ACCT) using RGS, whereas the control group solved standard cognitive tasks at home for an equivalent amount of time. A comprehensive test battery covering executive function, spatial awareness, attention, and memory as well as independence, depression, and motor impairment was applied at baseline, at 6 weeks and 18-weeks follow-up. RESULTS:At baseline, 75% of our sample had an impairment in more than one cognitive domain. The experimental group showed improvements in attention ([Formula: see text] (2)?=?9.57, p <?.01), spatial awareness ([Formula: see text] (2)?=?11.23, p <?.01) and generalized cognitive functioning ([Formula: see text] (2)?=?15.5, p <?.001). No significant change was seen in the executive function and memory domain. For the control group, no significant change over time was found. Further, they worsened in their depression level after treatment (T =?45, r?=?.72, p <?.01) but returned to baseline at follow-up. The experimental group displayed a lower level of depression than the control group after treatment (Ws =?81.5, z?=?-?2.76, r?=?-?.60, p <?.01) and (Ws =?92, z?=?-?2.03, r?=?-?.44, p <?.05). CONCLUSIONS:ACCT positively influences attention and spatial awareness, as well as depressive mood in chronic stroke patients. TRIAL REGISTRATION:The trial was registered prospectively at ClinicalTrials.gov (NCT02816008) on June 21, 2016.

Project description:BackgroundIn contrast to the large and increasing number of patients with stroke, clinical rehabilitation resources cannot meet their rehabilitation needs. Especially for those discharged, ways to carry out effective rehabilitation training without the supervision of physicians and receive guidance from physicians remain urgent problems to be solved in clinical rehabilitation and have become a research hot spot at home and abroad. At present, there are many studies on home rehabilitation training based on wearable devices, Kinect, among others, but these have disadvantages (eg, complex systems, high price, and unsatisfactory rehabilitation effects).ObjectiveThis study aims to design a remote intelligent rehabilitation training system based on wearable devices and human-computer interaction training tasks, and to evaluate the effectiveness and safety of the remote rehabilitation training system for nonphysician-supervised motor rehabilitation training of patients with stroke through a clinical trial study.MethodsA total of 120 inpatients with stroke having limb motor dysfunction were enrolled via a randomized, parallel-controlled method in the rehabilitation institutions, and a 3-week clinical trial was conducted in the rehabilitation hall with 60 patients in the experimental group and 60 in the control group. The patients in the experimental group used the remote rehabilitation training system for rehabilitation training and routine clinical physical therapy (PT) training and received routine drug treatment every day. The patients in the control group received routine clinical occupational therapy (OT) training and routine clinical PT training and routine drug treatment every day. At the beginning of the training (baseline) and after 3 weeks, the Fugl-Meyer Motor Function Rating scale was scored by rehabilitation physicians, and the results were compared and analyzed.ResultsStatistics were performed using SAS software (version 9.4). The total mean Fugl-Meyer score improved by 11.98 (SD 8.46; 95% CI 9.69-14.27) in the control group and 17.56 (SD 11.65; 95% CI 14.37-20.74) in the experimental group, and the difference between the 2 groups was statistically significant (P=.005). Among them, the mean Fugl-Meyer upper extremity score improved by 7.45 (SD 7.24; 95% CI 5.50-9.41) in the control group and 11.28 (SD 8.59; 95% CI 8.93-13.62) in the experimental group, and the difference between the 2 groups was statistically significant (P=.01). The mean Fugl-Meyer lower extremity score improved by 4.53 (SD 4.42; 95% CI 3.33-5.72) in the control group and 6.28 (SD 5.28; 95% CI 4.84-7.72) in the experimental group, and there was no significant difference between the 2 groups (P=.06). The test results showed that the experimental group was better than the control group, and that the patients' motor ability was improved.ConclusionsThe remote rehabilitation training system designed based on wearable devices and human-computer interaction training tasks can replace routine clinical OT training. In the future, through medical device registration certification, the system will be used without the participation of physicians or therapists, such as in rehabilitation training halls, and in remote environments, such as communities and homes.Trial registrationChinese Clinical Trial Registry ChiCTR2200061310; https://tinyurl.com/34ka2725.

Dataset Information

Glucose Regulation in Acute Stroke Patients (GRASP) trial: a randomized pilot trial.

Publications

Glucose Regulation in Acute Stroke Patients (GRASP) trial: a randomized pilot trial.

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