0.9% saline versus Plasma-Lyte as initial fluid in children with diabetic ketoacidosis (SPinK trial): a double-blind randomized controlled trial.

BACKGROUND: Acute kidney injury (AKI) is an important complication encountered during the course of diabetic ketoacidosis (DKA). Plasma-Lyte with lower chloride concentration than saline has been shown to be associated with reduced incidence of AKI in adults with septic shock. No study has compared this in DKA. METHODS: This double-blind, parallel-arm, investigator-initiated, randomized controlled trial compared 0.9% saline with Plasma-Lyte-A as initial fluid in pediatric DKA. The study was done in a tertiary care, teaching, and referral hospital in India in children (> 1 month-12 years) with DKA as defined by ISPAD. Children with cerebral edema or known chronic kidney/liver disease or who had received pre-referral fluids and/or insulin were excluded. Sixty-six children were randomized to receive either Plasma-Lyte (n = 34) or 0.9% saline (n = 32). MAIN OUTCOMES: Primary outcome was incidence of new or progressive AKI, defined as a composite outcome of change in creatinine (defined by KDIGO), estimated creatinine clearance (defined by p-RIFLE), and NGAL levels. The secondary outcomes were resolution of AKI, time to resolution of DKA (pH > 7.3, bicarbonate> 15 mEq/L & normal sensorium), change in chloride, pH and bicarbonate levels, proportion of in-hospital all-cause mortality, need for renal replacement therapy (RRT), and length of ICU and hospital stay. RESULTS: Baseline characteristics were similar in both groups. The incidence of new or progressive AKI was similar in both [Plasma-Lyte 13 (38.2%) versus 0.9% saline 15 (46.9%); adjusted OR 1.22; 95% CI 0.43-3.43, p = 0.70]. The median (IQR) time to resolution of DKA in Plasma-Lyte-A and 0.9% saline were 14.5 (12 to 20) and 16 (8 to 20) h respectively. Time to resolution of AKI was similar in both [Plasma-Lyte 22.1 versus 0.9% saline 18.8 h (adjusted HR 1.72; 95% CI 0.83-3.57; p = 0.14)]. Length of hospital stay was also similar in both [Plasma-Lyte 9 (8 to 12) versus 0.9% saline 10 (8.25 to 11) days; p = 0.39]. CONCLUSIONS: The incidence of new or progressive AKI and resolution of AKI were similar in both groups. Plasma-Lyte-A was similar to 0.9% Saline in time to resolution of DKA, need for RRT, mortality, and lengths of PICU and hospital stay. TRIAL REGISTRATION: Clinical trial registry of India, CTRI/2018/05/014042 (ctri.nic.in) (Retrospectively registered).

Are Salt Tablets Effective in the Treatment of Euvolemic Hyponatremia?

OBJECTIVES: There is limited evidence for the use of salt tablets in the treatment of hyponatremia. This retrospective study evaluated the effectiveness of salt tablet administration in euvolemic hyponatremia. METHODS: This was a single-center, retrospective cohort study. Information on patients' demographics, clinical characteristics, and laboratory data were collected for retrospective review. Treatment for hyponatremia, including the amount of salt tablets, fluid restriction, and diuretics was collected. We compared hyponatremic patients with those who received salt tablets versus those who did not receive salt tablets. The primary outcome of interest was the change in serum sodium at 48 hours between the two groups. RESULTS: A total of 1258 medical records were initially screened with inclusion and exclusion criteria. After screening, there were 83 patients included in the study. Forty-two patients received salt tablets and 41 patients were in the group that did not receive salt tablets. Patients treated with salt tablets were older, more often female, and had lower body weight and lower initial serum sodium. The change in serum sodium after 48 hours was higher in the salt tablet group (5.2 mEq/L) than the non-salt tablet group (3.1 mEq/L; P < 0.001). This difference in serum sodium between the two groups remained statistically significant when adjusted for age, sex, weight, and initial serum sodium. CONCLUSIONS: The use of salt tablets in the treatment of euvolemic hyponatremia is associated with a small but significant improvement in serum sodium compared with patients who did not receive such therapy, even after adjusting for age, sex, weight, and initial serum sodium. This study supports the effectiveness of salt tablets in the treatment of euvolemic hyponatremia in medical patients.

Toxicity testing of "eco-friendly" de-icing formulations using Chironomus dilutus.

An influx of chloride ions from road de-icing solutions can result in toxicological effects to organisms in terrestrial and aquatic environments. As such, "eco-friendly" de-icing alternatives are sought to mitigate environmental impacts of de-icing impervious surfaces, while maintaining human safety. While many alternative de-icers are economically impractical for municipal use, the residential commercial market is flooded with de-icing formulations claiming to be "eco-friendly". Given the little regulation and guidance that surrounds eco-labeling, the meaning of "eco-friendly" remains unclear in the context of biological systems. The objective of the current study was to determine the toxicity of three "eco-friendly" de-icing formulations to Chironomus dilutus using 10 d toxicity tests. The toxicity of these three formulations was compared to a traditional formulation composed entirely of chloride salts. Two of the "eco-friendly" de-icers demonstrated LC50s of 6.61 and 6.32 g/L, which were similar in toxicity to the traditional sodium chloride formulation with a LC50 6.29 g/L. The comparable toxicities of these formulations is likely due to the presence of chloride salts in each of the "eco-friendly" de-icers. The third "eco-friendly" formulation, a urea-based de-icer, demonstrated toxicity an order of magnitude higher than that of the traditional formulation with an LC50 of 0.63 g/L. While C. dilutus may not have been the intended endpoint in consideration when marketing these products as "eco-friendly", consideration of how eco-labeling is utilized and the role of environmental scientists in determining the meaning of such claims must be considered to ensure continued and future protection of the environment.

Stability of tacrolimus injection diluted in 0.9% sodium chloride injection and stored in Excel bags.

PURPOSE: The chemical stability and physical compatibility of tacrolimus i.v. infusion solutions prepared in Excel bags and stored at 23 or 4 °C for up to nine days were studied. METHODS: Tacrolimus admixtures (2, 4, and 8 µg/mL) were prepared in Excel bags using 0.9% sodium chloride injection and stored at 23 °C without protection from light or at 4 °C in the dark. Test samples were withdrawn from triplicate bag solutions immediately after preparation and at predetermined time intervals (1, 3, 5, 7, and 9 days). Chemical stability was assessed by measuring tacrolimus concentrations using a validated stability-indicating high-performance liquid chromatography assay. The physical stability of the admixtures was assessed by visual examination and by measuring turbidity, particle size, and drug content. RESULTS: All test solutions stored at 23 or 4 °C had a no greater than 6% loss of the initial tacrolimus concentration throughout the nine-day study period. All test samples of tacrolimus admixtures, under both storage conditions, were without precipitation and remained clear initially and throughout the nine-day observation period. Changes in turbidities were minor; measured particulates remained few in number in all samples throughout the study. CONCLUSION: Extemporaneously prepared infusion solutions of tacrolimus 2, 4, and 8 µg/mL in 0.9% sodium chloride injection in Excel bags were chemically and physically stable for at least nine days when stored at room temperature (23 °C) without protection from light and when stored in a refrigerator (4 °C) in the dark.

An evaluation of the efficacy of Aqualox for microbiological control of industrial cooling tower systems.

A comprehensive sampling protocol was employed to evaluate the efficacy of Aqualox, a biocide based on electrochemically activated water, against legionellae and heterotrophic bacteria in two industrial cooling tower systems. Both of the towers in the study remained free from evidence of Legionella spp. contamination throughout a five-month evaluation period, despite the previously demonstrated presence of legionellae in one of the test towers, and in two other towers on the same site, at levels well in excess of UK Health and Safety Commission (HSC) Approved Code of Practice and Guidance (ACOP) upper action limits. Levels of heterotrophic bacteria were controlled below 10(4) cfu/mL in both towers throughout most of the trial. Results also provided indirect evidence of significant activity against biofilm bacteria, with biofilm removal beginning almost immediately after commissioning of the Aqualox treatment systems. The results were particularly encouraging as the two towers studied had a long history of poor microbiological control using conventional bromine-based biocide products. Significant differences were observed between laboratory measurements of total viable counts on frequent liquid samples and those obtained from dip slides following HSC recommendations.

Physico-chemical stability and sterility of previously prepared saline infusion solutions for use in out-of-hospital emergencies.

OBJECTIVE: The topic of this research was to determine whether out-of-hospital emergency teams could make use of previously prepared saline solutions (SS). The objective was to discover the physical, chemical and sterility characteristics of previously prepared saline infusions stored in ambulances and ascertain how long they remained in optimum condition. METHOD: Randomised clinical trial, triple blind, where study units consisted of saline solutions prepared with an infusion system and a three-way valve. The duration of the study was 12 months. Six intervention groups were designed on the basis of time of exposure and location. Samples consisted of 672 units. Twelve microbiological cultures were made and the pH, density, viscosity and CINa concentration were determined. We compared hypotheses with four models of linear regression for the variables and a model of logistic regression for the variables. A value of P < 0.05 was considered significant. RESULTS: We obtained results from 669 saline solutions (98.82%). Neither multivariant analysis nor ANOVA tests showed any significant association for a power greater than 99% with regard to the physical-chemical characteristics. The model of logistic regression also did not find any significant association for sterility. Colonisation was present in 1.7% of the 8,028 cultures made and more than 5 CFU per millilitre was found in only two cases. CONCLUSION: There is no evidence to suggest that recently prepared saline infusion solutions are any different from a physical-chemical and sterility point of view than those exposed for 24, 48, or 72 h. It was concluded that use can be made of previously prepared saline solutions with a guarantee their stability and sterility.

Hyponatraemia and non-electrolyte solutions in labouring primigravida.

We performed a prospective randomised study on one hundred primigravid women who required oxytocin to augment labour, comparing dextrose infusion with normal saline. After delivery, the 45 patients whose oxytocin was infused in dextrose had significantly lower serum sodium levels in both mother and baby compared to the 48 patients who had their oxytocin administered in normal saline. This was particularly evident in those cases where epidural analgesia was employed.

Prospective randomized investigation for evaluation of postoperative changes in the microbial climate of paranasal mucosa by the use of different dissoluting techniques during postoperative care.

Endonasal dissolution by the use of NaCl-solution is a common postoperative treatment of the nasal mucosa after endonasal surgery. These procedure involve for example endonasal shower and sterilized solutions. The contamination of nasal shower in case of unprofessional cleaning after treatment was an argument against this technique in earlier discussions. The danger of such an infection should be avoided by the use of sterilized solution. Therefore the dependence of nasal microbial climate on different nasal dissoluting techniques was investigated by the use of such named endonasal shower (Siemens und Co, Bad Ems, Germany) in comparison with sterilized solution (Rhinomer, Zyma SA, Nyon, France). Microbial cultures were investigated of 80 patients after endonasal surgery (53 m, 27 f; 31 +/- 21 age). Surgery was done for the treatment of chronic polypous sinusitis. Pre-, intra- and postoperative samples were taken in 640 cases to proceed microbial cultures. Material was transferred with the use of a Port-A-Cul-transport medium and preparation of the microbial cultures was done during the first four hours. As a result 895 bacterial clones were cultivated. These consisted of 87% aerob and 13% anaerob bacteria. Staphylococcus aureus (39%) and members of the family of Enterobactericae (30%) were the most common microbes. There was neither an evidence for postoperative microbes on the nasal mucosa nor a correlation between the dissoluting technique and the postoperative outcome. The use of sterilized solutions for the postoperative care of endonasal mucosa does not cause an additional worthful effect on neither the postoperative microbial climate nor the outcome in comparison to endonasal shower.

Derivation of a salinity target for the Lower Murray Darling Valley.

The NSW Government commissioned catchment management boards (CMBs) to set the direction and process for catchment scale natural resource management. In the Lower Murray Darling, Rivers are highly regulated and water resources shared between three states. The Catchment Board only has jurisdiction over the northern bank of the Murray but salt and water enter the river from many locations upstream and along the area boundary. River salt and flow modelling has continually been improved to reflect and contribute to an increased understanding of salinity processes. The MDBC Salt Load study correlates 10 years of actual measured data with its modelled outputs, and estimates river salinities for 2020, 2050 and 2100. Routing models such as SALTFLO and MURKEY generate percentile salinity levels at different nodes in the River Murray downstream of the Lower Darling confluence. National, Murray-Darling Basin and NSW salinity management policy and legislative requirements were considered, MDBC model output was used to ensure the interim targets are achievable, auditable, and appropriate to the catchment. The method for an end-of-valley river based target for salinity is described. A target of less than 463 microS/cm for Lock 6, a point in the lower reaches of the Murray River is recommended for year 2010. Catchment management targets that express the main river salinity risk in five hydrologically distinct management zones are also recommended. Salinity management changes are needed in each zone to meet the end-of-valley target.

Compatibility of butorphanol and droperidol in 0.9% sodium chloride injection.

PURPOSE: The compatibility and stability of butorphanol tartrate and droperidol in polyvinyl chloride (PVC) bags and glass bottles stored at 4°C and 25°C for up to 15 days were studied. METHODS: Admixtures were assessed initially and for 15 days after preparation in PVC bags and glass bottles using 0.9% sodium chloride injection as a diluent and stored at 4°C and 25°C. The initial drug concentrations were 0.08 mg/mL for butorphanol tartrate and 0.05 mg/mL for droperidol. Samples were withdrawn from each container immediately after preparation and at predetermined intervals (2, 4, 8, 24, 48, 72, 120, 168, 240, and 360 hours after preparation). The solutions were visually inspected for precipitation, cloudiness, and discoloration at each sampling interval. Drug concentrations were determined using a validated high-pressure liquid chromatography method. RESULTS: After 15 days of storage, all formulations tested retained >98% of the initial concentrations of both drugs. The drug mixtures were clear in appearance, and no color change or precipitation was observed. Throughout this period, pH values remained stable. CONCLUSION: Admixtures of butorphanol tartrate 0.08 mg/mL and droperidol 0.05 mg/mL in 0.9% sodium chloride injection were stable for at least 360 hours when stored in PVC bags or glass bottles at 4°C and 25°C and protected from light.

In vitro function of buffy coat-derived platelet concentrates stored for 9 days in CompoSol, PASII or 100% plasma in three different storage bags.

BACKGROUND AND OBJECTIVES: The aim of the study was to compare the in vitro quality of buffy coat-derived platelet concentrates (PC) during extended storage in plasma or additive solution in three different storage bags. MATERIALS AND METHODS: A pooled and split design was chosen so that identical PCs were produced in either 100% plasma, 70% PASII : 30% plasma or 70% CompoSol : 30% plasma (n = 6 each). This was repeated for three different manufacturers' platelet storage bags (Fresenius, Baxter and Pall). PCs were sampled on days 1, 5, 7 and 9 of storage and tested in vitro using a variety of tests of platelet function. For each bag type, storage in PASII or Composol was compared with plasma (data taken across the entire storage period), and differences occurring with time were analysed for all storage media. RESULTS: The pH of all PCs was > 6.8 at day 9 of storage. In vitro platelet function, as assessed by markers of platelet activation and metabolism, of PCs stored in CompoSol appeared to be similar to that of PCs stored in plasma over 9 days of storage. In contrast, PCs stored in PASII tended to have significantly higher levels of platelet activation (almost a twofold increase in % platelets positive for CD62P by day 5) and lower hypotonic shock response (approximately 40%, by day 7) compared to either PCs stored in 100% plasma or 70% CompoSol. The magnitude of the differences observed between platelet storage media appeared to be dependent on the type of platelet storage bag with the highest degree of platelet activation and lowest hypotonic shock response values being observed in Fresenius bags in combination with PASII. CONCLUSIONS: The maintenance of platelet function in vitro during extended storage of PCs in platelet additive solutions is dependent on the combination of type of additive solution and type of platelet storage bag. For all bag types studied, storage in PASII resulted in poorer platelet function in vitro.