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[A comparison of two systems for hydration of children with diabetic ketoacidosis. a randomized controlled trial].
Ferreira, JP, Penazzi, M, Taborda, M, Funes, S, Villareal, M
Revista de la Facultad de Ciencias Medicas (Cordoba, Argentina). 2015;(2):93-9
Abstract
BACKGROUND Treatment of diabetic ketoacidosis (DKA) requires hourly controls of blood glucose, which define changes in the intravenous glucose and insulin administration. Every change requires preparing a new solution, wasting time and allowing errors. The two bag system (same electrolytes composition, but one with and the other without glucose) allows immediate changes in glucose administration rate, just by changing the solutions drip. OBJECTIVE To compare the time needed to reach stabilization of patients with DKA using two different hydration systems: the traditional one (1 glucose/electrolyte solution) vs. the alternative one (2 glucose/electrolyte solutions -"two bag system"-). METHODS Randomized controlled trial, including children aged 1 to 18 years, hospitalized for DKA (glycemia >200 mg/dl, pH <7.3, bicarbonate <15 mmol/L, glycosuria and ketonuria). After initial emergency re-hydration, patients were randomized to one of the 2 hydration systems (traditional or alternative), using it until patient stabilization (glycemia ≤250 mg/dl, pH ≥ 7.3, bicarbonate ≥ 15 mmol/L); the time required to reach stabilization was the outcome variable. RESULTS After enrolling 12 of the 32 planned subjects (6 in each group) Data Monitoring Committee performed a scheduled interim analysis, finding that the time required to reach stabilization was significantly shorter using the alternative system (9.8±1.16 hs vs. 13.3±2.8 hs; p=0.018). Because of the magnitude of this finding, the Ethics Committee decided to terminate the study.
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Cerebral edema in children with diabetic ketoacidosis: vasogenic rather than cellular?
Tasker, RC, Acerini, CL
Pediatric diabetes. 2014;(4):261-70
Abstract
Cerebral edema (CE) is accumulation of water in the intracellular or extracellular spaces of the brain. Vasogenic edema occurs when there is breakdown of the tight endothelial junctions of the blood-brain barrier (BBB), leading to extravasation of intravascular protein and fluid into the interstitial space of the brain. In cellular edema the BBB remains intact and there is swelling of astrocytes with corresponding reduction in extracellular space. In this review we bring together clinical evidence from neuropathology and cerebral magnetic resonance (MR) studies in pediatric patients presenting in diabetic ketoacidosis (DKA), and use applied physiology to understand whether CE complicating DKA is vasogenic, rather than cellular in origin. Because the first-line of defense against CE is the interface between the intravascular compartment and the extracellular space in the brain much of the focus in this review is the BBB. The principal pathologic finding in fatal cases is perivascular with BBB disruption and albumin extravasation, suggesting increased vascular permeability. DKA induces an inflammatory response and the mechanism of BBB transcellular permeability may be an immunologic cascade that disrupts tight junctions. The principal MR finding in subclinical cases of CE is vasogenic rather than cellular edema. We propose that the following physiology be considered when treating cases: bolus dose of intravenous mannitol may result in fall in serum sodium concentration, and therefore clinical worsening. Failure to respond to mannitol should prompt the use of 3% hypertonic saline (HS). Bolus dose of intravenous 3% HS is expected to effect vasogenic edema provided that the reflection coefficient is close to 1. Failure to respond to 3% HS should prompt the use of mannitol.
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Low-dose vs standard-dose insulin in pediatric diabetic ketoacidosis: a randomized clinical trial.
Nallasamy, K, Jayashree, M, Singhi, S, Bansal, A
JAMA pediatrics. 2014;(11):999-1005
Abstract
IMPORTANCE The standard recommended dose (0.1 U/kg per hour) of insulin in diabetic ketoacidosis (DKA) guidelines is not backed by strong clinical evidence. Physiologic dose-effect studies have found that even lower doses could adequately normalize ketonemia and acidosis. Lowering the insulin dose may be advantageous in the initial hours of therapy when a gradual decrease in glucose, electrolytes, and resultant osmolality is desired. OBJECTIVE To compare the efficacy and safety of low-dose insulin against the standard dose in children with DKA. DESIGN, SETTING, AND PARTICIPANTS This was a prospective, open-label randomized clinical trial conducted in the pediatric emergency department and intensive care unit of a tertiary care teaching hospital in northern India from November 1, 2011, through December 31, 2012. A total of 50 consecutive children 12 years or younger with a diagnosis of DKA were randomized to low-dose (n = 25) and standard-dose (n = 25) groups. INTERVENTIONS Low-dose (0.05 U/kg per hour) vs standard-dose (0.1 U/kg per hour) insulin infusion. MAIN OUTCOMES AND MEASURES The primary outcome was the rate of decrease in blood glucose until a level of 250 mg/dL or less is reached (to convert to millimoles per liter, multiply by 0.0555). The secondary outcomes included time to resolution of acidosis, episodes of treatment failures, and incidences of hypokalemia and hypoglycemia. RESULTS The mean (SD) rate of blood glucose decrease until a level of 250 mg/dL or less is reached (45.1 [17.6] vs 52.2 [23.4] mg/dL/h) and the mean (SD) time taken to achieve this target (6.0 [3.3] vs 6.2 [2.2] hours) were similar in the low- and standard-dose groups, respectively. Mean (SD) length of time to achieve resolution of acidosis (low vs standard dose: 16.5 [7.2] vs 17.2 [7.7] hours; P = .73) and rate of resolution of acidosis were also similar in the groups. Hypokalemia was seen in 12 children (48%) receiving the standard dose vs 5 (20%) of those receiving the low dose (P = .07); the tendency was more pronounced in malnourished children (7 [88%] vs 2 [28%]). Five children (20%) and 1 child (4%) receiving standard- and low-dose infusion (P = .17), respectively, developed hypoglycemia. Treatment failure was rare and comparable. One child in the standard-dose group developed cerebral edema, and no deaths occurred during the study period. CONCLUSIONS AND RELEVANCE Low dose is noninferior to standard dose with respect to rate of blood glucose decrease and resolution of acidosis. We advocate a superiority trial with a larger sample size before 0.05 U/kg per hour replaces 0.1 U/kg per hour in the practice recommendations. TRIAL REGISTRATION ctri.nic.in Identifier: CTRI/2012/04/002548.
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Effect of insulin therapy on IGF-1 level in children with new-onset type 1 diabetes mellitus: a comparison between DKA and non-DKA.
Shiva, S, Behbod, H, Ghergherechi, R
Journal of pediatric endocrinology & metabolism : JPEM. 2013;(9-10):883-6
Abstract
BACKGROUND AND OBJECTIVE The issue of insulin-like growth factor 1 (IGF-1) and diabetes in adults and type 2 diabetes has been well investigated. A few studies have investigated the serum IGF-1 level at the onset of type 1 diabetes mellitus (T1DM) in children. In the present study, we investigated the IGF-1 level of T1DM children before and after insulin therapy. SUBJECTS AND METHODS Between August 2011 and October 2012, 62 children with newly diagnosed T1DM were recruited. Serum IGF-1 levels were compared before and 1 month after insulin therapy between diabetic ketoacidosis (DKA) and non-DKA patients. RESULTS Thirty-one patients without DKA (18 girls and 13 boys, mean age 8.8 ± 3.01 years) and 31 patients with DKA (18 girls and 13 boys, mean age 8.3 ± 3.7 years) were studied. The mean IGF-1 in the DKA group was lower than that in the non-DKA group; however, this difference was not statistically significant (p=0.10). Serum IGF-1 levels increased significantly 1 month after insulin therapy in both the DKA (p<0.001) and non-DKA (p<0.001) groups. CONCLUSION Serum IGF-1 level is reduced in new-onset T1DM children. A significant increase in serum IGF-1 level can occur with insulin therapy in both DKA and non-DKA children.
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Low dose (0.05 units/kg/h) is comparable with standard dose (0.1 units/kg/h) intravenous insulin infusion for the initial treatment of diabetic ketoacidosis in children with type 1 diabetes-an observational study.
Puttha, R, Cooke, D, Subbarayan, A, Odeka, E, Ariyawansa, I, Bone, M, Doughty, I, Patel, L, Amin, R, ,
Pediatric diabetes. 2010;(1):12-7
Abstract
OBJECTIVE To compare low dose (0.05 units/kg/h) with standard dose (0.1 units/kg/h) intravenous insulin infusion for the treatment of diabetic ketoacidosis (DKA) in children with type 1 diabetes. STUDY DESIGN Data from five paediatric centres were compared in children who received 0.05 (41 episodes) or 0.1 units/kg/h (52 episodes). RESULTS In the low vs. standard dose group, at 6 h following admission, the fall in blood glucose levels [11.3 (95% confidence interval 8.6 to 13.9) vs. 11.8 (8.4 to 15.2) mmol/L, p = 0.86] and rise in pH [0.13 (0.09 to 0.18) vs. 0.11 (0.07 to 0.15), p = 0.78] were similar. These changes were comparable between doses in relation to: severity of initial acidosis, children newly diagnosed with diabetes or aged less than 5 years. After adjustment for other clinical and biochemical covariates, insulin dose was unrelated to the change in pH and blood glucose levels at 6 h following admission. Comparisons of safety data, particularly in relation to abnormal Glasgow Coma Score, were inconclusive. CONCLUSION In this observational study, low dose was as effective as standard dose intravenous insulin infusion in the initial treatment (less than 6 h) of DKA in children with type 1 diabetes. A randomised controlled trial is required to show true equivalence between doses and to evaluate potential safety benefits.
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Is subcutaneous administration of rapid-acting insulin as effective as intravenous insulin for treating diabetic ketoacidosis?
Mazer, M, Chen, E
Annals of emergency medicine. 2009;(2):259-63
Abstract
To determine whether intermittent subcutaneous administration of rapid-acting insulin is as effective as intravenous infusion of regular insulin for treating uncomplicated diabetic ketoacidosis, we performed a MEDLINE, EMBASE, and Cochrane Library search, using the key words "subcutaneous insulin AND intravenous insulin AND diabetic ketoacidosis; LIMIT humans and English." We also searched the references in these articles for additional studies. This search yielded a total of 35 articles, 4 of which directly addressed the question at hand. According to this review of the available evidence; subcutaneous administration of rapid-acting insulin analogs such as lispro is as effective and safe as intravenous infusion of regular insulin for the management of uncomplicated diabetic ketoacidosis. In addition, use of insulin analogs may confer an overall cost savings, obviating the need for infusion pumps and ICU admissions in certain institutions. Therefore, it would be safe and effective to use subcutaneously administered rapid-acting insulin analogues instead of intravenous regular insulin infusions for patients with uncomplicated diabetic ketoacidosis.
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Towards evidence based emergency medicine: best BETs from the Manchester Royal Infirmary. Capillary blood gases as an alternative to arterial puncture in diabetic ketoacidosis.
Clarke, SF
Emergency medicine journal : EMJ. 2007;(10):722-3
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Abstract
A short cut review was carried out to establish whether capillary blood rather than arterial blood can be used to assess acid base status in patients with diabetic ketoacidosis. A total of 25 papers were found using the reported searches, of which one presented the best evidence to answer the clinical question. The author, date and country of publication, patient group studied, study type, relevant outcomes, results and study weaknesses of this best paper are presented in table 1. It is concluded that while the correlations in the small study found were good, there is insufficient evidence to recommend adoption of this practice in the emergency setting.
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The case for venous rather than arterial blood gases in diabetic ketoacidosis.
Kelly, AM
Emergency medicine Australasia : EMA. 2006;(1):64-7
Abstract
OBJECTIVES For patients with diabetic ketoacidosis (DKA), arterial blood gas (BG) sampling for measurement of pH and bicarbonate has been considered an essential part of initial evaluation and monitoring of progress. There is growing evidence that venous values can be clinically acceptable alternatives to arterial measurements. This article summarizes the recent evidence regarding the validity of venous BG sampling in DKA. METHODS Medline search for the years 1995 to present, hand search of reference lists, search of on-line evidence-based medicine sites. RESULTS In patients with DKA the weighted average difference between arterial and venous pH was 0.02 pH units (95% limits of agreement -0.009 to +0.021 pH units) and between arterial and venous bicarbonate was -1.88 mEq/L. CONCLUSIONS There is reasonable evidence that venous and arterial pH have sufficient agreement as to be clinically interchangeable in patients with DKA who are haemodynamically stable and without respiratory failure. There is some evidence that venous and arterial bicarbonate also agree closely in DKA but this requires confirmation.
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Point-of-care test identifies diabetic ketoacidosis at triage.
Naunheim, R, Jang, TJ, Banet, G, Richmond, A, McGill, J
Academic emergency medicine : official journal of the Society for Academic Emergency Medicine. 2006;(6):683-5
Abstract
BACKGROUND Diabetic ketoacidosis (DKA) is a common, life-threatening complication of diabetes. The diagnosis of DKA relies on signs and symptoms, plus laboratory findings of blood glucose (BG) of > 250 mg/dL, an anion gap (AG) of > or = 15 mmol/L, and carbon dioxide (CO2) of < or = 18 mmol/L when other causes of acidosis are excluded. OBJECTIVES To compare the results of a point-of-care test for the ketone beta-hydroxybutyrate (beta-OHB) with standard measures for accuracy in predicting DKA. METHODS After providing informed consent, 160 patients who presented with BG of > 250 mg/dL underwent testing for beta-OHB with the Precision Xtra meter (Abbott Laboratories, North Chicago, IL) at triage in a large urban hospital emergency department. The diagnosis of DKA was made by clinicians by using standard clinical criteria without knowledge of the beta-OHB test. RESULTS A diagnosis of DKA was made in 57 of 160 subjects. The beta-OHB values correlated strongly with AG (r = 0.66, p < 0.001) and with CO2 (r = -0.69, p < 0.001), as well as with glucose (r = 0.31, p < 0.001). Cross-classification of DKA vs. beta-OHB yielded sensitivity of 98% (95% CI = 91% to 100%), specificity of 85% (95% CI = 78% to 91%), with a positive likelihood ratio of 6.7 (95% CI = 4.22 to 10.78), and negative likelihood ratio of 0.021 (95% CI = 0.003 to 0.144) at the manufacturer-suggested beta-OHB level of 1.5. CONCLUSIONS The point-of-care test for beta-OHB was as sensitive as more established indicators of DKA. It is more useful than glucose alone for the diagnosis of DKA and offers immediate diagnosis of patients at triage.
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Subcutaneous lispro and intravenous regular insulin treatments are equally effective and safe for the treatment of mild and moderate diabetic ketoacidosis in adult patients.
Ersöz, HO, Ukinc, K, Köse, M, Erem, C, Gunduz, A, Hacihasanoglu, AB, Karti, SS
International journal of clinical practice. 2006;(4):429-33
Abstract
In this prospective, randomised, open trial, we wanted to evaluate the efficacy and safety of hourly subcutaneous (SC) insulin lispro administration in the treatment of diabetic ketoacidosis (DKA) in comparison with intravenous (IV) regular insulin treatment. Twenty patients were enrolled in the study. The patients were randomly assigned into two groups. Following a bolus injection of 0.15 U/kg IV regular insulin, group L received half of this dose as hourly SC insulin lispro while group R was treated conventionally with IV regular insulin infusion. At the end of treatment period, time that needed for normalisation of serum glucose, beta-hydroxybutyrate, blood pH and urine ketone levels were not different in groups L and R. There was no mortality or serious side effects in both groups. In this study, we revealed that treatment of mild and moderate DKA with SC insulin lispro is equally effective and safe in comparison with IV regular insulin.