Project description:BackgroundSustained hyperglycemia is a known risk factor for adverse outcomes in critically ill patients. The specific aim was to determine if a nurse initiated insulin infusion protocol (IIP) was effective in maintaining blood glucose values (BG) within a target goal of 100-150 mg/dL across different intensive care units (ICUs) and to describe glycemic control during the 48 hours after protocol discontinuation.MethodsA descriptive, retrospective review of 366 patients having 28,192 blood glucose values in three intensive care units, Surgical Trauma Intensive Care Unit (STICU), Medical (MICU) and Coronary Care Unit (CCU) in a quaternary care hospital was conducted. Patients were > 15 years of age, admitted to STICU (n = 162), MICU (n = 110) or CCU (n = 94) over 8 months; October 2003-June 2004 and who had an initial blood glucose level > 150 mg/dL. We summarized the effectiveness and safety of a nurse initiated IIP, and compared these endpoints among STICU, MICU and CCU patients.ResultsThe median blood glucose values (mg/dL) at initiation of insulin infusion protocol were lower in STICU (188; IQR, 162-217) than in MICU, (201; IQR, 170-268) and CCU (227; IQR, 178-313); p < 0.0001. Mean time to achieving a target glucose level (100-150 mg/dL) was similar between the three units: 4.6 hours in STICU, 4.7 hours in MICU and 4.9 hours in CCU (p = 0.27). Hypoglycemia (BG < 60 mg/dL) occurred in 7% of STICU, 5% of MICU, and 5% of CCU patients (p = 0.85). Protocol violations were uncommon in all three ICUs. Mean blood glucose 48 hours following IIP discontinuation was significantly different for each population: 142 mg/dL in STICU, 167 mg/dL in MICU, and 160 mg/dL in CCU (p < 0.0001).ConclusionThe safety and effectiveness of nurse initiated IIP was similar across different ICUs in our hospital. Marked variability in glucose control after the protocol discontinuation suggests the need for further research regarding glucose control in patients transitioning out of the ICU.
Project description:BackgroundAdmissions to intensive care units (ICUs) are increasing due to an ageing population, and rising incidence of cardiac and respiratory disease. With advances in medical care, more patients are surviving an initial stay in critical care; however, they can experience ongoing health and cognitive limitations that may influence return to baseline function up to a year post-admission. Recent research has focused on the introduction of early rehabilitation within the ICU to reduce long-term physical and cognitive complications. The aim of this study is to explore the feasibility and impact of providing early enhanced occupation-based therapy, including cognitive stimulation and activities of daily living, to patients in intensive care.MethodsThis study involves a single site randomised-controlled feasibility trial comparing standard occupational therapy care to an early enhanced occupation-based therapy. Thirty mechanically ventilated ICU patients will be recruited and randomly allocated to the intervention or control group. The primary outcome measure is the Functional Independence Measure (FIM), and secondary measures include the Modified Barthel Index (MBI), Montreal Cognitive Assessment (MoCA), grip strength, Hospital Anxiety and Depression Scale (HADS) and Short-Form 36 Health survey (SF-36). Measures will be collected by a blind assessor at discharge from intensive care, hospital discharge and a 90-day follow-up. Daily outcome measures including the Glasgow Coma Scale (GCS), Richmond Agitation and Sedation Scale (RASS) and Confusion Assessment Measure for intensive care units (CAM-ICU) will be taken prior to treatment. Participants in the intervention group will receive daily a maximum of up to 60-min sessions with an occupational therapist involving cognitive and functional activities such as self-care and grooming. At the follow-up, intervention group participants will be interviewed to gain user perspectives of the intervention. Feasibility data including recruitment and retention rates will be summarised descriptively. Parametric tests will compare outcomes between groups. Interview data will be thematically analysed.DiscussionThis trial will provide information about the feasibility of investigating how occupational therapy interventions in ICU influence longer term outcomes. It seeks to inform the design of a phase III multicentre trial of occupational therapy in critical care general medical intensive care units.Trial registrationAustralia New Zealand Clinical Trials Registry (ANZCTR): ACTRN12618000374268 ; prospectively registered on 13 March 2018/ https://www.anzctr.org.au Trial funding: Metro South Health Research Support Scheme Postgraduate Scholarship.
Project description:The vascular endothelium controls vasomotor tone and microvascular flow and regulates trafficking of nutrients and biologically active molecules. When endothelial activation is excessive, compromised microcirculation and subsequent cellular hypoxia contribute to the risk of organ failure. We hypothesized that strict blood glucose control with insulin during critical illness protects the endothelium, mediating prevention of organ failure and death. In this preplanned subanalysis of a large, randomized controlled study, intensive insulin therapy lowered circulating levels of ICAM-1 and tended to reduce E-selectin levels in patients with prolonged critical illness, which reflects reduced endothelial activation. This effect was not brought about by altered levels of endothelial stimuli, such as cytokines or VEGF, or by upregulation of eNOS. In contrast, prevention of hyperglycemia by intensive insulin therapy suppressed iNOS gene expression in postmortem liver and skeletal muscle, possibly in part via reduced NF-kappaB activation, and lowered the elevated circulating NO levels in both survivors and nonsurvivors. These effects on the endothelium statistically explained a significant part of the improved patient outcome with intensive insulin therapy. In conclusion, maintaining normoglycemia with intensive insulin therapy during critical illness protects the endothelium, likely in part via inhibition of excessive iNOS-induced NO release, and thereby contributes to prevention of organ failure and death.
Project description:BackgroundEarly palliative care practice implementation in the intensive care unit (ICU) improves advance care planning, promotes patient and family satisfaction, and decreases health care costs. The consensus for protocolized palliative care delivery is unknown. We assessed the impact of a qualitive improvement educational intervention that promotes the identification of critically ill patients who will benefit from early expert palliative care interventions.MethodsIn this observational study, we examined the impact of an educational intervention that promoted (1) early detection of palliative care triggers (PCT) during ICU multidisciplinary rounds (MDRs), (2) admission and 48-hour pain assessment, and (3) family meetings within the first 72 hours of ICU admission among critically-ill patients in a mixed adult community ICU. The primary outcome was the monthly number of hospital-wide palliative care consultations pre- and post-intervention. Secondary outcomes included trends in the rate of PCT detection by the MDR team, pain assessment, and family meetings within 72 hours in ICU patients after the implementation of the education intervention.ResultsThe median monthly palliative care consultations progressively increased after the ICU-PAL implementation (preceding year: median 49 [45.5-54], first year: 70 [57.25-78.5], second year: 90 [79-105.25], P < .05 for all comparisons). Family meeting documentation within 72 hours among critically ill patients progressively became more frequent after implementation without changes in PCT detection in MDRs nor pain assessment frequency.ConclusionImplementing the ICU-PAL qualitive improvement initiative was associated with a consistent increase in the median average hospital-wide palliative care consultations over several years and a progressively increased rate of early family meetings in critically ill patients after its deployment.
Project description:BackgroundCritical care populations experience demographic shifts in response to trends in population and healthcare, with increasing severity and/or complexity of illness a common observation worldwide. Inflammation in critical illness impacts glucose-insulin metabolism, and hyperglycaemia is associated with mortality and morbidity. This study examines longitudinal trends in insulin sensitivity across almost a decade of glycaemic control in a single unit.MethodsA clinically validated model of glucose-insulin dynamics is used to assess hour-hour insulin sensitivity over the first 72 h of insulin therapy. Insulin sensitivity and its hour-hour percent variability are examined over 8 calendar years alongside severity scores and diagnostics.ResultsInsulin sensitivity was found to decrease by 50-55% from 2011 to 2015, and remain low from 2015 to 2018, with no concomitant trends in age, severity scores or risk of death, or diagnostic category. Insulin sensitivity variability was found to remain largely unchanged year to year and was clinically equivalent (95% confidence interval) at the median and interquartile range. Insulin resistance was associated with greater incidence of high insulin doses in the effect saturation range (6-8 U/h), with the 75th percentile of hourly insulin doses rising from 4-4.5 U/h in 2011-2014 to 6 U/h in 2015-2018.ConclusionsIncreasing insulin resistance was observed alongside no change in insulin sensitivity variability, implying greater insulin needs but equivalent (variability) challenge to glycaemic control. Increasing insulin resistance may imply greater inflammation and severity of illness not captured by existing severity scores. Insulin resistance reduces glucose tolerance, and can cause greater incidence of insulin saturation and resultant hyperglycaemia. Overall, these results have significant clinical implications for glycaemic control and nutrition management.
Project description:ObjectiveThe purpose of this study was to analyze the economic outcomes of a clinical program implemented to achieve strict glycemic control with intensive insulin therapy in patients admitted to the intensive care unit (ICU).Research design and methodsA difference-in-differences (quasi-experimental) study design was used to examine the associations of an intensive insulin therapy intervention with changes in hospital length of stay (ICU and total), costs (ICU and total), and mortality. Hospital administrative data were obtained for 6,719 adult patients admitted between 2003 and 2005 to one of five intervention or four comparison ICUs in a large academic medical center. Linear regression models with log transformations and appropriate retransformations were used to estimate length of stay (LOS) and costs; logistic regressions were used to estimate mortality.ResultsAfter adjustment for observable patient characteristics and secular time trends, the intervention was consistently associated with lower average glucose levels and a trend toward shorter LOS, lower costs, and lower mortality. However, associations with resource use and outcomes were statistically significant in only ICU LOS, with an average reduction of 1.19 days of ICU care per admission. Other associations, although large in magnitude and in the hypothesized directions, were not estimated with sufficient precision to rule out other net effects. The associations with ICU days and costs were larger in magnitude than total days and costs.ConclusionsA clinical team focused on hyperglycemia management for ICU patients can be a valuable investment with significant economic benefits for hospitals.
Project description:BackgroundObservational studies have shown improvement in patients with type 2 diabetes mellitus after bariatric surgery.MethodsIn this randomized, nonblinded, single-center trial, we evaluated the efficacy of intensive medical therapy alone versus medical therapy plus Roux-en-Y gastric bypass or sleeve gastrectomy in 150 obese patients with uncontrolled type 2 diabetes. The mean (±SD) age of the patients was 49±8 years, and 66% were women. The average glycated hemoglobin level was 9.2±1.5%. The primary end point was the proportion of patients with a glycated hemoglobin level of 6.0% or less 12 months after treatment.ResultsOf the 150 patients, 93% completed 12 months of follow-up. The proportion of patients with the primary end point was 12% (5 of 41 patients) in the medical-therapy group versus 42% (21 of 50 patients) in the gastric-bypass group (P=0.002) and 37% (18 of 49 patients) in the sleeve-gastrectomy group (P=0.008). Glycemic control improved in all three groups, with a mean glycated hemoglobin level of 7.5±1.8% in the medical-therapy group, 6.4±0.9% in the gastric-bypass group (P<0.001), and 6.6±1.0% in the sleeve-gastrectomy group (P=0.003). Weight loss was greater in the gastric-bypass group and sleeve-gastrectomy group (-29.4±9.0 kg and -25.1±8.5 kg, respectively) than in the medical-therapy group (-5.4±8.0 kg) (P<0.001 for both comparisons). The use of drugs to lower glucose, lipid, and blood-pressure levels decreased significantly after both surgical procedures but increased in patients receiving medical therapy only. The index for homeostasis model assessment of insulin resistance (HOMA-IR) improved significantly after bariatric surgery. Four patients underwent reoperation. There were no deaths or life-threatening complications.ConclusionsIn obese patients with uncontrolled type 2 diabetes, 12 months of medical therapy plus bariatric surgery achieved glycemic control in significantly more patients than medical therapy alone. Further study will be necessary to assess the durability of these results. (Funded by Ethicon Endo-Surgery and others; ClinicalTrials.gov number, NCT00432809.).
Project description:BackgroundLong-term results from randomized, controlled trials that compare medical therapy with surgical therapy in patients with type 2 diabetes are limited.MethodsWe assessed outcomes 5 years after 150 patients who had type 2 diabetes and a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of 27 to 43 were randomly assigned to receive intensive medical therapy alone or intensive medical therapy plus Roux-en-Y gastric bypass or sleeve gastrectomy. The primary outcome was a glycated hemoglobin level of 6.0% or less with or without the use of diabetes medications.ResultsOf the 150 patients who underwent randomization, 1 patient died during the 5-year follow-up period; 134 of the remaining 149 patients (90%) completed 5 years of follow-up. At baseline, the mean (±SD) age of the 134 patients was 49±8 years, 66% were women, the mean glycated hemoglobin level was 9.2±1.5%, and the mean BMI was 37±3.5. At 5 years, the criterion for the primary end point was met by 2 of 38 patients (5%) who received medical therapy alone, as compared with 14 of 49 patients (29%) who underwent gastric bypass (unadjusted P=0.01, adjusted P=0.03, P=0.08 in the intention-to-treat analysis) and 11 of 47 patients (23%) who underwent sleeve gastrectomy (unadjusted P=0.03, adjusted P=0.07, P=0.17 in the intention-to-treat analysis). Patients who underwent surgical procedures had a greater mean percentage reduction from baseline in glycated hemoglobin level than did patients who received medical therapy alone (2.1% vs. 0.3%, P=0.003). At 5 years, changes from baseline observed in the gastric-bypass and sleeve-gastrectomy groups were superior to the changes seen in the medical-therapy group with respect to body weight (-23%, -19%, and -5% in the gastric-bypass, sleeve-gastrectomy, and medical-therapy groups, respectively), triglyceride level (-40%, -29%, and -8%), high-density lipoprotein cholesterol level (32%, 30%, and 7%), use of insulin (-35%, -34%, and -13%), and quality-of-life measures (general health score increases of 17, 16, and 0.3; scores on the RAND 36-Item Health Survey ranged from 0 to 100, with higher scores indicating better health) (P<0.05 for all comparisons). No major late surgical complications were reported except for one reoperation.ConclusionsFive-year outcome data showed that, among patients with type 2 diabetes and a BMI of 27 to 43, bariatric surgery plus intensive medical therapy was more effective than intensive medical therapy alone in decreasing, or in some cases resolving, hyperglycemia. (Funded by Ethicon Endo-Surgery and others; STAMPEDE ClinicalTrials.gov number, NCT00432809 .).
Project description:BackgroundIn short-term randomized trials (duration, 1 to 2 years), bariatric surgery has been associated with improvement in type 2 diabetes mellitus.MethodsWe assessed outcomes 3 years after the randomization of 150 obese patients with uncontrolled type 2 diabetes to receive either intensive medical therapy alone or intensive medical therapy plus Roux-en-Y gastric bypass or sleeve gastrectomy. The primary end point was a glycated hemoglobin level of 6.0% or less.ResultsThe mean (±SD) age of the patients at baseline was 48±8 years, 68% were women, the mean baseline glycated hemoglobin level was 9.3±1.5%, and the mean baseline body-mass index (the weight in kilograms divided by the square of the height in meters) was 36.0±3.5. A total of 91% of the patients completed 36 months of follow-up. At 3 years, the criterion for the primary end point was met by 5% of the patients in the medical-therapy group, as compared with 38% of those in the gastric-bypass group (P<0.001) and 24% of those in the sleeve-gastrectomy group (P=0.01). The use of glucose-lowering medications, including insulin, was lower in the surgical groups than in the medical-therapy group. Patients in the surgical groups had greater mean percentage reductions in weight from baseline, with reductions of 24.5±9.1% in the gastric-bypass group and 21.1±8.9% in the sleeve-gastrectomy group, as compared with a reduction of 4.2±8.3% in the medical-therapy group (P<0.001 for both comparisons). Quality-of-life measures were significantly better in the two surgical groups than in the medical-therapy group. There were no major late surgical complications.ConclusionsAmong obese patients with uncontrolled type 2 diabetes, 3 years of intensive medical therapy plus bariatric surgery resulted in glycemic control in significantly more patients than did medical therapy alone. Analyses of secondary end points, including body weight, use of glucose-lowering medications, and quality of life, also showed favorable results at 3 years in the surgical groups, as compared with the group receiving medical therapy alone. (Funded by Ethicon and others; STAMPEDE ClinicalTrials.gov number, NCT00432809.).