Dataset Information

Serial monitoring of the physiological effects of the standard Pico-Salax® regimen for colon cleansing in healthy volunteers.

ABSTRACT: BACKGROUND:Sodium picosulfate?magnesium oxide?citric acid (Pico-Salax, Ferring Inc, Canada) is used widely in Canada and other countries for colon cleansing before colonoscopy. It is a low-volume osmotic?stimulant agent with the potential to deplete intravascular volume and alter electrolyte balance, yet there are little data regarding its effects on these clinically important end points. OBJECTIVE:To serially measure parameters of intravascular volume and electrolyte status in healthy volunteers over a 24 h period using the standard two-sachet dosing. METHODS:Twenty volunteers were given one sachet of Pico-Salax at time 0 h and another sachet 5 h later, as per usual bowel cleansing protocol. Subjects were continually monitored during the first 12 h of the study with postural vital signs, serum electrolytes and electrocardiograms obtained at intervals throughout this initial period and again at 24 h postingestion. RESULTS:No adverse events were reported nor were there any signs of intravascular volume depletion observed. There were decreases in potassium and calcium levels from baseline to 12 h, but these appeared minor and were corrected by 24 h. The proportions of patients with hypermagnesmia at 0 h, 5 h, 12 h and 24 h were 5%, 35%, 35% and 20%, respectively (P<0.05). However, the maximal values were only minimally elevated. Mean serum sodium, phosphate and creatinine levels remained within their respective reference ranges. There was a trend toward an increase in maximum corrected QT intervals from time 0 h (418 ms) to 5 h (430 ms) (P=0.06), but no significant change was seen subsequently at 12 h (419 ms). The subjects tolerated the medication well. The mean number of bowel movements per subject was 8.15 (range four to 15). Subjects consumed a mean (± SD) of 3.49±1.53 L of fluids during the observation period. CONCLUSIONS:The proportion of individuals with hypokalemia, hypocalcemia and hypermagnesemia following two sachets of Pico-Salax is significant, but the magnitude of the changes was not clinically relevant in this relatively small group, and both calcium and potassium levels normalized at 24 h. Nonetheless, this could have implications in patients with pre-existing electrolyte abnormalities and the safety of dosing with more than two sachets.

SUBMITTER: Rahman A

PROVIDER: S-EPMC3395442 | biostudies-literature | 2012 Jul

REPOSITORIES: biostudies-literature

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Serial monitoring of the physiological effects of the standard Pico-Salax® regimen for colon cleansing in healthy volunteers.

Rahman Adam A Vanner Stephen J SJ Baranchuk Adrian A Hookey Lawrence C LC

Canadian journal of gastroenterology = Journal canadien de gastroenterologie 20120701 7

<h4>Background</h4>Sodium picosulfate⁄magnesium oxide⁄citric acid (Pico-Salax, Ferring Inc, Canada) is used widely in Canada and other countries for colon cleansing before colonoscopy. It is a low-volume osmotic⁄stimulant agent with the potential to deplete intravascular volume and alter electrolyte balance, yet there are little data regarding its effects on these clinically important end points.<h4>Objective</h4>To serially measure parameters of intravascular volume and electrolyte status in he ...[more]

PMID: 22803016

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Project description:BackgroundDelays in treating anaesthesia-induced malignant hyperthermia increase risks of complications and death. NPJ5008 is a novel formulation of the indicated treatment, dantrolene sodium, developed to shorten preparation and administration times compared with the reference formulation Dantrium®. The two formulations have been compared preclinically.ObjectivesAssess bioequivalence of overall dantrolene (free acid) exposure of NPJ5008 versus Dantrium® and ascertain similarities in their pharmacokinetics and safety/tolerability profiles. Evaluate preparation/administration time savings for the new formulation.DesignPart 1 of this open-label trial in humans was a 1 : 1 randomised crossover study; part 2 was a single-arm study. Trial pharmacy data and laboratory simulations assessed preparation/administration step timings.SettingSingle clinical centre in the UK, April to July 2021.ParticipantsTwenty-one healthy male and female individuals.InterventionsPart 1: single intravenous 60 mg dose of NPJ5008 or Dantrium®, sequentially. Part 2: single intravenous 120 mg dose of NPJ5008. Simulation: five vials per formulation using paediatric and adult cannulas.Main outcome measuresOverall drug exposure to last measurable concentration (AUC 0 to last ) and extrapolated to infinity (AUC 0 to ∞ ) were primary endpoints. Other pharmacokinetic, clinical and muscle-function parameters, and adverse events, were monitored.ResultsAdjusted geometric mean ratios of NPJ5008 versus Dantrium® were 90.24 and 90.44% for AUC 0 to last and AUC 0 to ∞ , respectively, with the 90% confidence intervals (CI) within the 80 to 125% acceptance interval, establishing bioequivalence. No new safety issues emerged: any adverse events were of a similar magnitude across treatments and related to pharmacological properties of dantrolene. Pharmacy and simulation data revealed that every step in preparation and administration was 26 to 69% faster for NPJ5008 than Dantrium®.ConclusionNPJ5008 showed comparable pharmacokinetic and safety profiles to Dantrium®, while reducing dantrolene dose preparation/administration times, potentially reducing patient complications/healthcare resourcing in malignant hyperthermia.Trial registrationEudraCT Number: 2020-005719-35, MHRA approval.

Project description:Audiologists regularly use serial monitoring to evaluate changes in a patient's auditory function over time. Observed changes are compared with reference standards to determine whether further clinical action is necessary. Reference standards are established in a control sample of otherwise healthy subjects to identify the range of auditory shifts that one might reasonably expect to occur in the absence of any pathological insult. Statistical approaches to this seemingly mundane problem typically invoke 1 of 3 approaches: percentiles of the cumulative distribution, the variance of observed shifts, and the "standard error of measurement." In this article, the authors describe the statistical foundation for these approaches, along with a mixed model-based alternative, and identify several necessary, although typically unacknowledged assumptions. Regression to the mean, the phenomenon of an unusual measurement typically followed by a more common one, can seriously bias observed changes in auditory function and clinical expectations. An approach that adjusts for this important effect is also described.Distortion product otoacoustic emissions (DPOAEs) elicited at a single primary frequency, f2 of 3175 Hz, were collected from 32 healthy subjects at baseline and 19 to 29 days later. Ninety percent test-retest reference limits were computed from these data using each statistical approach. DPOAE shifts were also collected from a sample of 18 cisplatin patients tested after 120 to 200?mg of cisplatin. Reference limits established according to each of the statistical approaches in the healthy sample were used to identify clinically alarming DPOAE shifts in the cisplatin patient sample.Reference limits established with any of the parametric methods were similar. The percentile-based approach gave the widest and least precisely estimated intervals. The highest sensitivity for detecting clinically alarming DPOAE shifts was based on a mixed model approach that adjusts for regression to the mean.Parametric methods give similar serial monitoring criteria as long as certain critical assumptions are met by the data. The most flexible method for estimating test-retest limits is based on the linear mixed model. Clinical sensitivity may be further enhanced by adjusting for regression to the mean.

Dataset Information

Serial monitoring of the physiological effects of the standard Pico-Salax® regimen for colon cleansing in healthy volunteers.

Publications

Serial monitoring of the physiological effects of the standard Pico-Salax® regimen for colon cleansing in healthy volunteers.

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