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The Effect of Hypo-Hydration on Mood and Cognition Is Influenced by Electrolyte in a Drink and Its Colour: A Randomised Trial.
Cousins, AL, Young, HA, Thomas, AG, Benton, D
Nutrients. 2019;(9)
Abstract
Traditionally, it has been thought necessary to lose 2% of body mass due to dehydration to disrupt functioning, although recently, adverse effects have been reported, with a loss of 0.5%-0.7%. It is, however, unclear whether the response to small reductions in mass reflects dehydration as homeostatic mechanisms are thought to be effective. As psychological responses are most commonly reported, it is strange that the possibility of a placebo response has not been considered. Individuals were therefore subject to a temperature of 30 °C for three hours, and mood and cognition were monitored. To consider changes in hydration status, drinks were compared, differing in their ability to rehydrate due to the presence or absence of electrolytes. The possibility of a placebo response was considered by comparing the response to plain or coloured water. Not drinking was disruptive, although a combination of plain water and electrolyte tended to be the most effective means of preventing a decline in mood, indicating a role for rehydration after a loss of 0.66% body mass. There was, however, also evidence of a placebo response: a combination of plain water and electrolyte tended to be better able to prevent a decline in mood than coloured water and electrolyte.
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Multicentre endoscopist-blinded randomised clinical trial to compare two bowel preparations after a colonoscopy with inadequate cleansing: a study protocol.
Sey, MSL, von Renteln, D, Sultanian, R, McDonald, C, Martel, M, Barkun, A
BMJ open. 2019;(7):e029573
Abstract
INTRODUCTION Inadequate bowel preparation is common and negatively impacts colonoscopy quality. The objective of this study is to compare two bowel preparation regimens in cleansing the colon after an index colonoscopy with failed bowel preparation. METHODS AND ANALYSIS This is a phase III, multicentre, randomised clinical trial comparing two bowel preparation regimens after failure to adequately cleanse at the index colonoscopy. Regimen A consists of 4 L split-dose polyethylene glycol electrolyte solution (PEG-ELS) and Regimen B consists of 6 L split-dose PEG-ELS, both preceded by 15 mg of bisacodyl the day before the procedure along with a low-fibre diet 3 and 2 days before the procedure followed by a clear fluid diet starting the day before the procedure. The primary outcome is adequate bowel preparation, defined as a Boston Bowel Preparation Scale (BBPS) score of ≥6 with each segment score ≥2. Secondary outcomes include mean BBPS score, bowel preparation adequacy using the US Multi-Society Task Force on Colorectal Cancer definition, detection rate by polyp subtype, caecal intubation rate, mean Validated Patient Tolerability Questionnaire for Bowel Preparation score, subject willingness to repeat the preparation and faecal incontinence rate. ETHICS AND DISSEMINATION The study will be conducted in accordance with Good Clinical Practice guidelines and local institutional standards. Study findings will be disseminated at an international gastroenterology conference and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER NCT02976805; Pre-results.
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Balanced Crystalloids versus Saline in Critically Ill Adults.
Semler, MW, Self, WH, Wanderer, JP, Ehrenfeld, JM, Wang, L, Byrne, DW, Stollings, JL, Kumar, AB, Hughes, CG, Hernandez, A, et al
The New England journal of medicine. 2018;(9):829-839
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Abstract
BACKGROUND Both balanced crystalloids and saline are used for intravenous fluid administration in critically ill adults, but it is not known which results in better clinical outcomes. METHODS In a pragmatic, cluster-randomized, multiple-crossover trial conducted in five intensive care units at an academic center, we assigned 15,802 adults to receive saline (0.9% sodium chloride) or balanced crystalloids (lactated Ringer's solution or Plasma-Lyte A) according to the randomization of the unit to which they were admitted. The primary outcome was a major adverse kidney event within 30 days - a composite of death from any cause, new renal-replacement therapy, or persistent renal dysfunction (defined as an elevation of the creatinine level to ≥200% of baseline) - all censored at hospital discharge or 30 days, whichever occurred first. RESULTS Among the 7942 patients in the balanced-crystalloids group, 1139 (14.3%) had a major adverse kidney event, as compared with 1211 of 7860 patients (15.4%) in the saline group (marginal odds ratio, 0.91; 95% confidence interval [CI], 0.84 to 0.99; conditional odds ratio, 0.90; 95% CI, 0.82 to 0.99; P=0.04). In-hospital mortality at 30 days was 10.3% in the balanced-crystalloids group and 11.1% in the saline group (P=0.06). The incidence of new renal-replacement therapy was 2.5% and 2.9%, respectively (P=0.08), and the incidence of persistent renal dysfunction was 6.4% and 6.6%, respectively (P=0.60). CONCLUSIONS Among critically ill adults, the use of balanced crystalloids for intravenous fluid administration resulted in a lower rate of the composite outcome of death from any cause, new renal-replacement therapy, or persistent renal dysfunction than the use of saline. (Funded by the Vanderbilt Institute for Clinical and Translational Research and others; SMART-MED and SMART-SURG ClinicalTrials.gov numbers, NCT02444988 and NCT02547779 .).
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Comparison of normal saline and balanced crystalloid (plasmalyte) in patients undergoing elective craniotomy for supratentorial brain tumors: A randomized controlled trial.
Dey, A, Adinarayanan, S, Bidkar, PU, Bangera, RK, Balasubramaniyan, V
Neurology India. 2018;(5):1338-1344
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BACKGROUND The choice of fluid is important in neurosurgical patients, who may be dehydrated due to the administration of diuretics in order to reduce cerebral edema. Normal saline, the infused fluid routinely used in neurosurgical patients, can cause hyperchloremic metabolic acidosis. A balanced crystalloid (BC) may help to maintain the metabolic status more favorably in these patients, without adversely affecting brain relaxation. METHODS We conducted a prospective, randomized controlled trial on patients undergoing elective craniotomy for supratentorial tumor resection under general anesthesia. 44 patients were randomly allocated into two groups of 22 each to receive either normal saline or BC (Plasmalyte) as the maintenance fluid, intra-operatively. The metabolic parameters and osmolality were measured at regular intervals. Brain relaxation score was assessed by the operating surgeon. The patients were monitored with serum neutrophil gelatinase-associated lipocalin (NGAL), blood urea and serum creatinine for assessing the degree of acute kidney injury. RESULTS The metabolic profile was better maintained with the BC. The brain relaxation score was comparable between the two groups. The postoperative NGAL, urea and creatinine values were significantly higher in the normal saline group compared to the BC group. CONCLUSION The balanced crystalloid maintains metabolic status more favorably than normal saline in neurosurgical patients. Hyperchloremic metabolic acidosis, and the other problems which occur as a consequence of normal saline infusion may be circumvented by choosing a balanced crystalloid electrolyte solution. Neither of the crystalloids appeared to have any adverse effect on brain relaxation.
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Calcium Mass Balance during Citrate Hemodialysis: A Randomized Controlled Trial Comparing Normal and Low Ionized Calcium Target Ranges.
Gubensek, J, Orsag, A, Ponikvar, R, Buturovic-Ponikvar, J
PloS one. 2016;(12):e0168593
Abstract
BACKGROUND Regional citrate anticoagulation (RCA) during hemodialysis interferes with calcium homeostasis. Optimal ionized calcium (iCa) target range during RCA and consequent calcium balance are unknown. METHODS In a randomized controlled trial (ACTRN12613001029785) 30 chronic hemodialysis patients were assigned to normal (1.1-1.2 mmol/) or low (0.95-1.05 mmol/l) iCa target range during a single hemodialysis with RCA. The primary outcome was calcium mass balance during the procedure, using a partial spent dialysate collection method; magnesium mass balance was also measured. Intact parathormone (iPTH), total calcium (tCa) and magnesium were measured before and after procedures. RESULTS Mean iCa during procedures was significantly different in the two groups (1.12±0.06 in normal and 1.06±0.07 mmol/l in low iCa group, p <0.001), resulting in different tCa (2.18±0.22 vs. 1.95±0.17, p = 0.003) after the procedure. Mean delivered calcium during the procedure was 58.3±4.8 mmol in the normal and 51.5±8.2 mmol in the low iCa group (p = 0.010), which resulted in a significantly higher mean positive calcium mass balance of 14.6±8.3 mmol (584±333 mg) per procedure in normal as compared to 7.2±8.5 mmol (290±341 mg) in low iCa group (p = 0.024). Linear mixed effects model showed a significant interaction effect of time and iCa target range group on iPTH, i.e. a significant increase in iPTH in the low as compared to normal iCa target group (p = 0.008). Magnesium mass balance was mildly negative and comparable in both groups. CONCLUSIONS Low iCa target range resulted in a significantly less positive calcium mass balance, but in a significant increase in iPTH. To achieve a more neutral calcium balance, we recommend allowing a mild hypocalcemia during hemodialysis with RCA, especially when it is used for prolonged periods.
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A Comparative Study of Treatment-Emergent Adverse Events Following Use of Common Bowel Preparations Among a Colonoscopy Screening Population: Results from a Post-Marketing Observational Study.
Anastassopoulos, K, Farraye, FA, Knight, T, Colman, S, Cleveland, MV, Pelham, RW
Digestive diseases and sciences. 2016;(10):2993-3006
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BACKGROUND Colonoscopy may be one of the most frequent elective procedures in older adults and is associated with a low occurrence of complications. However, reduction of risks attributable to the bowel preparation may be achieved with the use of effective and safer products. AIM: The aim of this study was to examine the incidence of treatment-emergent adverse events (TEAEs) associated with SUPREP(®) [oral sulfate solution (OSS)] and other common prescription bowel preparations (non-OSS). METHODS This real-world, observational study used de-identified health insurance claims and laboratory results to identify TEAEs in the 3 months following screening colonoscopy in adults with a prescription for a bowel preparation in the prior 60 days. The unadjusted and adjusted (controlling for patient risk factors) cumulative incidences of TEAEs were estimated using Kaplan-Meier and Poisson regression, respectively. RESULTS Among patients ≥45 years, the overall cumulative incidence was significantly lower (p < 0.001) in the OSS cohort than in the non-OSS cohort (unadjusted: 2.31 vs. 2.89 %; adjusted: 1.61 vs. 1.95 %), with significantly lower acute cardiac conditions (1.56 vs. 1.90 %; p < 0.001), renal failure/other serious renal diseases (OSS: 0.21 %, non-OSS: 0.32 %; p < 0.001), and serum electrolyte abnormalities (OSS: 0.39 %, non-OSS: 0.49 %; p = 0.017). There were no significant differences between cohorts in death, seizure disorders, aggravation of gout, and ischemic colitis. Results were similar in the adjusted cumulative incidences. CONCLUSIONS In actual use, the overall cumulative incidence of TEAEs was significantly lower in the OSS cohort, demonstrating that OSS is as safe as, or possibly safer than, non-OSS prescription bowel preparations.
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Comparison of the effectiveness of polyethylene glycol with and without electrolytes in constipation: a systematic review and network meta-analysis.
Katelaris, P, Naganathan, V, Liu, K, Krassas, G, Gullotta, J
BMC gastroenterology. 2016;:42
Abstract
BACKGROUND Polyethylene glycol is commonly used to manage constipation and is available with or without electrolytes. The addition of electrolytes dates back to its initial development as lavage solutions in preparation for gastrointestinal interventions. The clinical utility of the addition of electrolytes to polyethylene glycol for the management of constipation is not established. The objective of this systematic review and network meta-analysis (NMA) was to assess the relative effectiveness of polyethylene glycol with (PEG + E) or without electrolytes (PEG) in the management of functional constipation in adults. METHODS A systematic review was conducted to identify randomised controlled clinical trials that assessed the use of polyethylene glycol in functional constipation. The primary outcome was the mean number of bowel movements per week. RESULTS Nineteen studies were included in the NMA (PEG N = 9, PEG + E N = 8, PEG versus PEG + E N = 2; involving 2247 patients). PEG and PEG + E are both effective, increasing the number of bowel movements per week by 1.8 (95 % Crl 1.0, 2.8) and 1.9 (95 % Crl 0.9, 3.0) respectively versus placebo and by 1.8 (95 % Crl 0.0, 3.5) and 1.9 (95 % Crl 0.2, 3.6) respectively versus lactulose. There was no efficacy difference between PEG + E and PEG (0.1, 95 % Crl -1.1, 1.2) and there were no differences in safety or tolerability. CONCLUSIONS Polyethylene glycol with and without electrolytes are effective and safe treatments for constipation in adults. The addition of electrolytes to polyethylene glycol does not appear to offer any clinical benefits over polyethylene glycol alone in the management of constipation.
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Perioperative use of crystalloids in patients undergoing open radical cystectomy: balanced Ringer's maleate versus a glucose 5%/potassium-based balanced solution: study protocol for a randomized controlled trial.
Löffel, LM, Kleeb, B, Burkhard, FC, Wuethrich, PY
Trials. 2014;:276
Abstract
BACKGROUND The optimal crystalloid solution to use perioperatively in patients undergoing open radical cystectomy remains unclear. Many of the fluids used for intravenous hydration contain supraphysiologic concentrations of chloride, which can induce hyperchloremia and metabolic acidosis, resulting in renal vasoconstriction and decreased renal function. In addition, patients receiving less fluid and less sodium show faster recovery of gastrointestinal (GI) function after colonic surgery. METHODS AND DESIGN This is an investigator-initiated, single-center, randomized, controlled, parallel group trial with assessor-blinded outcome assessment, in the Department of Urology, University Hospital Bern, Switzerland. The study will involve 44 patients with bladder cancer scheduled for radical cystectomy and urinary diversion. The primary outcome is the duration between the end of surgery and the return of the GI function (first defecation). Secondary outcomes are fluid balance (body weight difference postoperatively versus preoperatively) and the incidence of kidney function disorders according to the Risk-Injury-Failure-Loss-End Stage Renal Disease (RIFLE classification). An equal number of patients are allocated to receive Ringerfundin® solution or a glucose/potassium-based balanced crystalloid solution as baseline infusion during the entire time that intravenous administration of fluid is necessary during the perioperative period. The randomized crystalloid solution is infused at a rate of 1 ml/kg/h until the bladder has been removed, followed by 3 ml/kg/h until the end of surgery. Postoperative hydration is identical in both groups and consists of 1,500 ml of the randomized crystalloid solution per 24 hours. Postoperative patient care is identical in both groups; patients are allowed to drink clear fluids immediately after surgery, and liquid diet is started on postoperative day 1, as well as active mobilization and the use of chewing gum. Body weight is measured daily in the morning. Time of first flatus and first defecation are recorded. DISCUSSION This trial assesses the benefits and harms of two different balanced crystalloid solutions for perioperative fluid management in patients undergoing open radical cystectomy with urinary diversion, with regard to return of GI function and effects on postoperative renal function. TRIAL REGISTRATION Current Controlled Trials ISRCTN32976792 (registered on November 21 2013).
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A prospective comparative study of haemodynamic, electrolyte, and metabolic changes during percutaneous nephrolithotomy and minimally invasive percutaneous nephrolithotomy.
Xu, S, Shi, H, Zhu, J, Wang, Y, Cao, Y, Li, K, Wang, Y, Sun, Z, Xia, S
World journal of urology. 2014;(5):1275-80
Abstract
OBJECTIVES To report the haemodynamic, electrolyte, and metabolic changes of a prospective clinical trial comparing minimally invasive percutaneous nephrolithotomy (MPCNL) with percutaneous nephrolithotomy (PCNL) for renal stones. METHODS In all, 71 patients who had undergone MPCNL (37) or PCNL (34) were prospectively assessed. Heart rate and arterial blood pressure were monitored, and samples for electrolyte estimation and arterial blood gas analysis were drawn at the start, 30th, 60th, 90th, and 120th min of irrigation and 24 h later after both procedures. RESULTS In the PCNL group, no significant changes occurred in heart rate, arterial blood pressure, electrolytes, and pH. In the MPCNL group, heart rate, arterial blood pressure, and serum sodium levels kept stably during and after irrigation; the decrease in potassium levels was found from the 30th to 120th min of irrigation and did not recovery until 24 h later after operation (P < 0.05), but the potassium levels was normal during the entire observation period; the increase in Cl(-) levels was noted at the 120th min of irrigation (P < 0.05); there was a decreasing trend of pH from the start to the 120th min of irrigation (P < 0.05) and 24 h later after operation this trend attenuated (P < 0.05); the changes in base excess levels were in accordance with those in pH levels. CONCLUSIONS Although haemodynamic and electrolyte changes remains stable, a trend towards metabolic acidosis is obvious as the irrigation time goes by during MPCNL compared with PCNL. Therefore, arterial blood gases should be monitored during and after MPCNL in patients with prolonged irrigation time.
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Saline versus Plasma-Lyte A in initial resuscitation of trauma patients: a randomized trial.
Young, JB, Utter, GH, Schermer, CR, Galante, JM, Phan, HH, Yang, Y, Anderson, BA, Scherer, LA
Annals of surgery. 2014;(2):255-62
Abstract
OBJECTIVE We sought to compare resuscitation with 0.9% NaCl versus Plasma-Lyte A, a calcium-free balanced crystalloid solution, hypothesizing that Plasma-Lyte A would better correct the base deficit 24 hours after injury. BACKGROUND Sodium chloride (0.9%) (0.9% NaCl), though often used for resuscitation of trauma patients, may exacerbate the metabolic acidosis that occurs with injury, and this acidosis may have detrimental clinical effects. METHODS We conducted a randomized, double-blind, parallel-group trial (NCT01270854) of adult trauma patients requiring blood transfusion, intubation, or operation within 60 minutes of arrival at the University of California Davis Medical Center. Based on a computer-generated, blocked sequence, subjects received either 0.9% NaCl or Plasma-Lyte A for resuscitation during the first 24 hours after injury. The primary outcome was mean change in base excess from 0 to 24 hours. Secondary outcomes included 24-hour arterial pH, serum electrolytes, fluid balance, resource utilization, and in-hospital mortality. RESULTS Of 46 evaluable subjects (among 65 randomized), 43% had penetrating injuries, injury severity score was 23 ± 16, 20% had admission systolic blood pressure less than 90 mm Hg, and 78% required an operation within 60 minutes of arrival. The baseline pH was 7.27 ± 0.11 and base excess -5.9 ± 5.0 mmol/L. The mean improvement in base excess from 0 to 24 hours was significantly greater with Plasma-Lyte A than with 0.9% NaCl {7.5 ± 4.7 vs 4.4 ± 3.9 mmol/L; difference: 3.1 [95% confidence interval (CI): 0.5-5.6]}. At 24 hours, arterial pH was greater [7.41 ± 0.06 vs 7.37 ± 0.07; difference: 0.05 (95% CI: 0.01-0.09)] and serum chloride was lower [104 ± 4 vs 111 ± 8 mEq/L; difference: -7 (95% CI: -10 to -3)] with Plasma-Lyte A than with 0.9% NaCl. Volumes of study fluid administered, 24-hour urine output, measures of resource utilization, and mortality did not significantly differ between the 2 arms. CONCLUSIONS Compared with 0.9% NaCl, resuscitation of trauma patients with Plasma-Lyte A resulted in improved acid-base status and less hyperchloremia at 24 hours postinjury. Further studies are warranted to evaluate whether resuscitation with Plasma-Lyte A improves clinical outcomes.