Clinical Effects of Balanced Crystalloids vs Saline in Adults With Diabetic Ketoacidosis: A Subgroup Analysis of Cluster Randomized Clinical Trials.

Importance: Saline (0.9% sodium chloride), the fluid most commonly used to treat diabetic ketoacidosis (DKA), can cause hyperchloremic metabolic acidosis. Balanced crystalloids, an alternative class of fluids for volume expansion, do not cause acidosis and, therefore, may lead to faster resolution of DKA than saline. Objective: To compare the clinical effects of balanced crystalloids with the clinical effects of saline for the acute treatment of adults with DKA. Design, Setting, and Participants: This study was a subgroup analysis of adults with DKA in 2 previously reported companion trials-Saline Against Lactated Ringer's or Plasma-Lyte in the Emergency Department (SALT-ED) and the Isotonic Solutions and Major Adverse Renal Events Trial (SMART). These trials, conducted between January 2016 and March 2017 in an academic medical center in the US, were pragmatic, multiple-crossover, cluster, randomized clinical trials comparing balanced crystalloids vs saline in emergency department (ED) and intensive care unit (ICU) patients. This study included adults who presented to the ED with DKA, defined as a clinical diagnosis of DKA, plasma glucose greater than 250 mg/dL, plasma bicarbonate less than or equal to 18 mmol/L, and anion gap greater than 10 mmol/L. Data analysis was performed from January to April 2020. Interventions: Balanced crystalloids (clinician's choice of Ringer lactate solution or Plasma-Lyte A solution) vs saline for fluid administration in the ED and ICU according to the same cluster-randomized multiple-crossover schedule. Main Outcomes and Measures: The primary outcome was time between ED presentation and DKA resolution, as defined by American Diabetes Association criteria. The secondary outcome was time between initiation and discontinuation of continuous insulin infusion. Results: Among 172 adults included in this secondary analysis of cluster trials, 94 were assigned to balanced crystalloids and 78 to saline. The median (interquartile range [IQR]) age was 29 (24-45) years, and 90 (52.3%) were women. The median (IQR) volume of isotonic fluid administered in the ED and ICU was 4478 (3000-6372) mL. Cumulative incidence analysis revealed shorter time to DKA resolution in the balanced crystalloids group (median time to resolution: 13.0 hours; IQR: 9.5-18.8 hours) than the saline group (median: 16.9 hours; IQR: 11.9-34.5 hours) (adjusted hazard ratio [aHR] = 1.68; 95% CI, 1.18-2.38; P = .004). Cumulative incidence analysis also revealed shorter time to insulin infusion discontinuation in the balanced crystalloids group (median: 9.8 hours; IQR: 5.1-17.0 hours) than the saline group (median: 13.4 hours; IQR: 11.0-17.9 hours) (aHR = 1.45; 95% CI, 1.03-2.03; P = .03). Conclusions and Relevance: In this secondary analysis of 2 cluster randomized clinical trials, compared with saline, treatment with balanced crystalloids resulted in more rapid resolution of DKA, suggesting that balanced crystalloids may be preferred over saline for acute management of adults with DKA. Trial Registration: ClinicalTrials.gov Identifiers: NCT02614040; NCT02444988.

Saline versus balanced crystalloids for intravenous fluid therapy in the emergency department: study protocol for a cluster-randomized, multiple-crossover trial.

BACKGROUND: Prior studies in critically ill patients suggest the supra-physiologic chloride concentration of 0.9% ("normal") saline may be associated with higher risk of renal failure and death compared to physiologically balanced crystalloids. However, the comparative effects of 0.9% saline and balanced fluids are largely unexamined among patients outside the intensive care unit, who represent the vast majority of patients treated with intravenous fluids. METHODS/DESIGN: This study, entitled Saline Against Lactated Ringer's or Plasma-Lyte in the Emergency Department (SALT-ED), is a pragmatic, cluster, multiple-crossover trial at a single institution evaluating clinical outcomes of adults treated with 0.9% saline versus balanced crystalloids for intravenous fluid resuscitation in the emergency department. All adults treated in the study emergency department receiving at least 500 mL of isotonic crystalloid solution during usual clinical care and subsequently hospitalized outside the intensive care unit are included. Treatment allocation of 0.9% saline versus balanced crystalloids is assigned by calendar month, with study patients treated during the same month assigned to the same fluid type. The first month (January 2016) was randomly assigned to balanced crystalloids, with each subsequent month alternating between 0.9% saline and balanced crystalloids. For balanced crystalloid treatment, clinicians can choose either Lactated Ringer's or Plasma-Lyte A©. The study period is set at 16 months, which will result in an anticipated estimated sample size of 15,000 patients. The primary outcome is hospital-free days to day 28, defined as the number of days alive and out of the hospital from the index emergency department visit until 28 days later. Major secondary outcomes include proportion of patients who develop acute kidney injury by creatinine measurements; major adverse kidney events by hospital discharge or day 30 (MAKE30), which is a composite outcome of death, new renal replacement therapy, and persistent creatinine elevation >200% of baseline; and in-hospital mortality. DISCUSSION: This ongoing pragmatic trial will provide the most comprehensive evaluation to date of clinical outcomes associated with 0.9% saline compared to physiologically balanced fluids in patients outside the intensive care unit. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02614040 . Registered on 18 November 2015.

Embracing a Nurse-Driven Alcohol Withdrawal Protocol Through Quality Improvement.

BACKGROUND: Alcohol withdrawal can lead to severe complications including seizures, delirium tremens, and death if not treated appropriately. Nurses are critical to the safety and outcomes of these patients. OBJECTIVE: The objective of this retrospective study was to determine if nursing education on a community hospital's alcohol withdrawal protocol led to improved nursing compliance. METHODS: This is a quality improvement project involving a two-part retrospective review-an initial needs assessment followed by nursing education and a subsequent posteducation retrospective review. The initial needs assessment included 65 patients. The subsequent posteducation group included 50 patients. RESULTS: Nursing compliance of 1-hour assessments increased after the educational intervention; however, there was no statistically significant difference in 6-hour assessment or medication administration protocol compliance between preeducation and posteducation groups. CONCLUSION: Nursing education is a good place to start in improving compliance with an alcohol withdrawal protocol, but physicians need to be included to increase standardization within the institution. Future study should look at the effectiveness of different assessment frequency intervals and its impact on patient-centered outcomes.

Correlation of patient-reported outcomes of sedation and sedation assessment scores in critically ill patients.

PURPOSE: Patient-reported outcomes (PROs) are recommended as indicators of quality in the intensive care unit. We studied the correlation between PROs of sedation quality and a universal sedation assessment scale in critically ill patients. MATERIALS AND METHODS: Twenty-nine mechanically ventilated adults admitted to a surgical/trauma or medical intensive care unit requiring continuous infusion sedation for 24 hours or more were prospectively included. Patient-reported outcomes were evaluated through sedation questionnaire 24 hours post-continuous infusion sedation. The primary outcome was the correlation of PROs with Sedation-Agitation Scale (SAS) scores. RESULTS: Mean (SD) SAS scores per 12-hour nursing shift for propofol (n=179), midazolam (n=42), and dexmedetomidine (n=8) were 3.78 (77), 3.31 (1.1), and 2.98 (0.76), respectively. The mean score for survey questions addressing perceptions of comfort was 5.3 (1, complete comfort; 10, not comfortable at all). Of the patients, 34%, 7%, and 52% would want more, less, or the same amount of sedation, respectively, if this situation were to arise again. Patient perception of comfort correlated with the percent time at goal SAS score; r=0.31 (P<.05). CONCLUSION: Patient-reported outcomes of sedation correlate with the percentage of time spent in the goal range of scores for a universal sedation assessment scale. These findings represent initial attempts to appreciate the patient's perspective in the management and monitoring of agitation.