Dataset Information

Insulin glucose infusion versus nebulised salbutamol versus combination of salbutamol and insulin glucose in acute hyperkalaemia in the emergency room: protocol for a randomised, multicentre, controlled study (INSAKA).

ABSTRACT: INTRODUCTION:Hyperkalaemia is a common electrolyte disorder and can be life-threatening. In the emergency room (ER), interventions aim to protect patients from the immediate dangers of elevated serum potassium by redistributing potassium ions from the bloodstream into the cells via intravenous insulin or nebulised beta2-agonists. However, to date, evidence for acute management of hyperkalaemia is limited. The aim of this randomised controlled trial is therefore to compare three strategies, namely insulin/glucose intravenous infusion, nebulised salbutamol or a combination of nebulised salbutamol and insulin/glucose intravenous infusion to reduce serum potassium concentration at 60?min as a first-line treatment in patients admitted to the ER with serum potassium concentrations superior or equal to 6?mmol/L. METHODS AND ANALYSIS:INSAKA is a prospective, multicentre, controlled, open-label, parallel-group, randomised in a 1:1:1 ratio clinical trial. Patients will be eligible for randomisation if they have serum potassium concentrations superior or equal to 6?mmol/L measured in the ER. Patients will receive either: (1) 10?mg of nebulised salbutamol, (2) 10 units of short-acting insulin in an intravenous bolus with 500?mL of 10% glucose or (3) 10 units of short-acting insulin in an intravenous bolus with 500?mL of 10% glucose combined with 10?mg of nebulised salbutamol. The primary endpoint will be the mean change in the absolute serum potassium level from baseline to 60?min measured in mmol/L. We plan to include 525 patients. ETHICS AND DISSEMINATION:The INSAKA trial will be conducted in accordance with the International Council on Harmonization Good Clinical Practices. All trial documents and procedures have been reviewed and approved by the Ethics Committee Sud Méditerranée III (approval ID number: 19.07.16.36428). The results will be actively disseminated through peer-reviewed journals, conference presentations, social media, broadcast media, print media and the internet. TRIAL REGISTRATION:EudraCT number: 2019-002710-39, Clinicaltrials.gov identifier: NCT04012138.

SUBMITTER: Montassier E

PROVIDER: S-EPMC7451466 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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Insulin glucose infusion versus nebulised salbutamol versus combination of salbutamol and insulin glucose in acute hyperkalaemia in the emergency room: protocol for a randomised, multicentre, controlled study (INSAKA).

Montassier Emmanuel E Lemoine Loic L Hardouin Jean Benoit JB Rossignol Patrick P Legrand Matthieu M

BMJ open 20200826 8

<h4>Introduction</h4>Hyperkalaemia is a common electrolyte disorder and can be life-threatening. In the emergency room (ER), interventions aim to protect patients from the immediate dangers of elevated serum potassium by redistributing potassium ions from the bloodstream into the cells via intravenous insulin or nebulised beta2-agonists. However, to date, evidence for acute management of hyperkalaemia is limited. The aim of this randomised controlled trial is therefore to compare three strategie ...[more]

PMID: 32847923

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Project description:ObjectivesTo determine if liver cirrhosis is associated with reduced efficacy of insulin-glucose treatment in moderate to severe hyperkalaemia.DesignRetrospective, cohort study.SettingTwo secondary and one tertiary care hospital at a large metropolitan healthcare network in Melbourne, Australia.ParticipantsThis study included 463 adults with a mean age of 68.7±15.8 years, comprising 79 patients with cirrhosis and 384 without cirrhosis as controls, who received standard insulin-glucose treatment for a serum potassium ≥6.0 mmol/L from October 2016 to March 2020. Patients were excluded if they received an insulin infusion, or if there was inadequate follow-up data for at least 6 hours after IDT due to death, lost to follow-up or inadequate biochemistry monitoring. The mean Model for End-stage Liver Disease score in patients with cirrhosis was 22.2±7.5, and the distribution of the Child-Pugh score for cirrhosis was: class A (24%), class B (46%), class C (30%).Outcome measuresThe primary outcome was the degree of potassium lowering and the secondary outcome was the proportion of patients who achieved normokalaemia, within 6 hours of treatment.ResultsThe mean pretreatment potassium for the cohort was 6.57±0.52 mmol/L. After insulin-glucose treatment, mean potassium lowering was 0.84±0.58 mmol/L in patients with cirrhosis compared with 1.33±0.75 mmol/L for controls (p<0.001). The proportion of patients achieving normokalaemia was 33% for patients with cirrhosis, compared with 53% for controls (p=0.001). By multivariable regression, on average, liver cirrhosis was associated with a reduced potassium lowering effect of 0.42 mmol/L (95% CI 0.22 to 0.63 mmol/L, p<0.001) from insulin-glucose treatment, after adjusting for age, serum creatinine, cancer, pretreatment potassium level, β-blocker use and cotreatments (sodium polystyrene sulfonate, salbutamol, sodium bicarbonate).ConclusionsOur observational data suggest reduced efficacy of insulin-glucose treatment for hyperkalaemia in patients with cirrhosis.

Project description:BackgroundPatients at their end-of-life (EOL) phase frequently visit the emergency department (ED) due to their symptoms, yet the environment and physicians in ED are not traditionally equipped or trained to provide palliative care. This multicentre study aims to measure the current quality of EOL care in ED to identify gaps, formulate improvements and implement the improved EOL care protocol. We shall also evaluate healthcare resource utilisation and its associated costs.Methods and analysisThis study employs a quasiexperimental interrupted time series design using both qualitative and quantitative methods, involving the EDs of three tertiary hospitals in Singapore, over a period of 3 years. There are five phases in this study: (1) retrospective chart reviews of patients who died within 5 days of ED attendance; (2) pilot phase to validate the CODE questionnaire in the local context; (3) preimplementation phase; (4) focus group discussions (FGDs); and (5) postimplementation phase. In the prospective cohort, patients who are actively dying or have high likelihood of mortality this admission, and whose goal of care is palliation, will be eligible for inclusion. At least 140 patients will be recruited for each preimplementation and postimplementation phase. There will be face-to-face interviews with patients' family members, review of medical records and self-administered staff survey to evaluate existing knowledge and confidence. The FGDs will involve hospital and community healthcare providers. Data obtained from the retrospective cohort, preimplementation phase and FGDs will be used to guide prospective improvement and protocol changes. Patient, family and staff relevant outcomes from these changes will be measured using time series regression.Ethics and disseminationThe study protocol has been reviewed and ethics approval obtained from the National Healthcare Group Domain Specific Review Board, Singapore. The results from this study will be actively disseminated through manuscript publications and conference presentations.Trial registration numberNCT03906747.

Project description:Background: Emergency rooms (ERs) overcrowded by older adults have been the focus of public health policies during the recent COVID-19 outbreak too. This phenomenon needed a change in the nursing care of older frail people. Health policies have tried to mitigate the frequent use of ER by implementing community care to meet the care demands of older adults. The present study aimed to investigate the predictors of emergency room access (ERA) and not-urgent emergency room access (NUERA) of community-dwelling frail older adults in order to provide an indication for out-of-hospital care services. Method: Secondary analysis of an observational longitudinal cohort study was carried out. The cohort consisted of 1,246 community-dwelling frail older adults (over 65 years) in the Latium region in Italy. The ER admission rate was assessed over 3 years from the administration of the functional geriatric evaluation (FGE) questionnaire. The ordinal regression model was used to identify the predictors of ERA and NUERA. Moreover, the ERA and NUERA rate per 100 observations/year was analyzed. Results: The mean age was 73.6 (SD ± 7.1) years, and 53.4% were women. NUERAs were the 39.2% of the ERAs; robust and pre-frail individuals (79.3% of the sample) generated more than two-third of ERAs (68.17%), even if frails and very frails showed the higher ER rates per observation/year. The ordinal logistic regression model highlighted a predictive role on ERAs of comorbidity (OR = 1.13, p < 0.001) and frailty level (OR = 1.29; p < 0.001). Concerning NUERAs, social network (OR 0.54, P = 0.015) and a medium score of pulmo-cardio-vascular function (OR 1.50, P = 0.006) were the predictors. Conclusion: Comorbidity, lack of social support, and functional limitations increase both ERA and NUERA rates generated by the older adult population. Overall, bio-psycho-social frailty represents an indicator of the frequency of ERAs. However, to reduce the number of ERAs, intervention should focus mainly on the robust and pre-frail needs for prevention and care.

Dataset Information

Insulin glucose infusion versus nebulised salbutamol versus combination of salbutamol and insulin glucose in acute hyperkalaemia in the emergency room: protocol for a randomised, multicentre, controlled study (INSAKA).

Publications

Insulin glucose infusion versus nebulised salbutamol versus combination of salbutamol and insulin glucose in acute hyperkalaemia in the emergency room: protocol for a randomised, multicentre, controlled study (INSAKA).

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