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Febuxostat combined with hydration for the prevention of contrast-induced nephropathy in hyperuricemia patients undergoing percutaneous coronary intervention: A CONSORT-compliant randomized controlled trial.
Ma, G, Li, M, Teng, W, He, Z, Zhai, X, Xia, Z
Medicine. 2022;(4):e28683
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Abstract
BACKGROUND To assess the efficacy of febuxostat combined with hydration on contrast-induced nephropathy (CIN) in coronary heart disease patients with hyperuricemia undergoing percutaneous coronary intervention (PCI). METHODS Patients with hyperuricemia who underwent PCI were randomly assigned to 2 groups. The control group was given hydration only, and the febuxostat group received febuxostat 40 mg daily before administration of contrast agent and hydration. The primary endpoint of the study was the incidence of CIN, defined as an increase in baseline serum creatinine concentration by 25% at 2 days after contrast media administration, and variations in the serum levels of creatinine, neutrophil gelatinase-associated lipocalin, uric acid, and estimated glomerular filtration rate were compared. RESULTS A total of 202 patients with hyperuricemia were randomly assigned to either the febuxostat group (n = 100) or the control group (n = 102). The baseline characteristics of the 2 groups were similar. The incidence of CIN was 6.0% (6/100) in the febuxostat group and 14.71% (15/102) in the control group.The levels of neutrophil gelatinase-associated lipocalin at 6-hour and serum creatinine and uric acid at 48-hour in the febuxostat combined hydration group were lower than those in the control group after surgery, and the level of estimated glomerular filtration rate was higher than that in the control group (all P < .05). Multivariate logistic regression analysis revealed that febuxostat was an independent predictor of CIN. CONCLUSION Our study demonstrated that prophylactic treatment with febuxostat combined with hydration can reduce the incidence of CIN in patients with coronary heart disease and hyperuricemia after PCI.
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The effect of type of fluid on disease severity in acute pancreatitis treatment.
Kayhan, S, Selcan Akyol, B, Ergul, M, Baysan, C
European review for medical and pharmacological sciences. 2021;(23):7460-7467
Abstract
OBJECTIVE In this study, we aimed to investigate the effect of type of fluid (Normal Saline solution: NSS or Lactated Ringer's solution: LRS) to be selected in fluid replacement in acute pancreatitis (AP) treatment on disease severity. SUBJECTS AND METHODS This study is a prospective, single-center study. Patients diagnosed with acute pancreatitis in emergency service were included in the study and randomized to receive LRS or NSS. The severity of AP was determined regarding Revised Atlanta Classification. C-reactive protein (CRP) levels and serum pH and bicarbonate (HCO3) levels were measured to evaluate the systemic inflammatory response and to detect changes in acid-base balance, respectively. RESULTS Sixty-five and seventy-seven patients receiving NSS and LRS, respectively, were analyzed. Eighty-nine (67.4%) and 43 (32.6%) patients were with mild and moderate AP, respectively; however, there was no patient with severe AP. The frequency of moderate AP was significantly lower in the LRS group than the NSS group in terms of the severity of AP (p=0.011). Subjects that were randomized to receive LRS had lower CRP levels when compared to the participants in the NSS treatment arm 48 hours after resuscitation (p=0.010). In addition to these results, serum pH and HCO3 level in patients resuscitated with NSS reduced in comparison to LRS (p<0.001). CONCLUSIONS Resuscitation with LRS is associated with decreased severity of AP in patients with AP. It may derive from how it causes lower CRP levels.
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Preoperative carbohydrate loading and intraoperative goal-directed fluid therapy for elderly patients undergoing open gastrointestinal surgery: a prospective randomized controlled trial.
Liu, X, Zhang, P, Liu, MX, Ma, JL, Wei, XC, Fan, D
BMC anesthesiology. 2021;(1):157
Abstract
BACKGROUND The effect of a combination of a goal-directed fluid protocol and preoperative carbohydrate loading on postoperative complications in elderly patients still remains unknown. Therefore, we designed this trial to evaluate the relative impact of preoperative carbohydrate loading and intraoperative goal-directed fluid therapy versus conventional fluid therapy (CFT) on clinical outcomes in elderly patients following gastrointestinal surgery. METHODS This prospective randomized controlled trial with 120 patients over 65 years undergoing gastrointestinal surgery were randomized into a CFT group (n = 60) with traditional methods of fasting and water-deprivation, and a GDFT group (n = 60) with carbohydrate (200 ml) loading 2 h before surgery. The CFT group underwent routine monitoring during surgery, however, the GDFT group was conducted by a Vigileo/FloTrac monitor with cardiac index (CI), stroke volume variation (SVV), and mean arterial pressure (MAP). For all patients, demographic data, intraoperative parameters and postoperative outcomes were recorded. RESULTS Patients in the GDFT group received significantly less crystalloids fluid (1111 ± 442.9 ml vs 1411 ± 412.6 ml; p < 0.001) and produced significantly less urine output (200 ml [150-300] vs 400 ml [290-500]; p < 0.001) as compared to the CFT group. Moreover, GDFT was associated with a shorter average time to first flatus (56 ± 14.1 h vs 64 ± 22.3 h; p = 0.002) and oral intake (72 ± 16.9 h vs 85 ± 26.8 h; p = 0.011), as well as a reduction in the rate of postoperative complications (15 (25.0%) vs 29 (48.3%) patients; p = 0.013). However, postoperative hospitalization or hospitalization expenses were similar between groups (p > 0.05). CONCLUSIONS Focused on elderly patients undergoing open gastrointestinal surgery, we found perioperative fluid optimisation may be associated with improvement of bowel function and a lower incidence of postoperative complications. TRIAL REGISTRATION ChiCTR, ChiCTR1800018227 . Registered 6 September 2018 - Retrospectively registered.
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Avoiding the emergence of contrast-induced acute kidney injury in acute coronary syndrome: routine hydration treatment.
Arslan, S, Yildiz, A, Dalgic, Y, Batit, S, Kilicarslan, O, Ser, OS, Dalgic, SN, Kocas, C, Abaci, O
Coronary artery disease. 2021;(5):397-402
Abstract
BACKGROUND Patients with acute coronary syndrome (ACS) have about a three-fold risk for developing contrast-induced acute kidney injury(CI-AKI). Investigating studies on routine hydration therapy have frequently included patients with stable coronary artery disease and high risk of CI-AKI [estimated glomerular filtration rate (eGFR) < 60 ml/min]. However, data on routine hydration treatment in non-ST segment elevation myocardial infarction (NSTEMI) patients with eGFR ≥60 ml/min are insufficient. We aimed to investigate the association between routine hydration therapy and CI-AKI development in NSTEMI patients at low risk for nephropathy. METHODS AND RESULTS We randomly assigned a total of 401 NSTEMI patients to two groups: the routine hydration group (198 patients) and the nonhydration group (control group) (203 patients). Intravenous hydration with isotonic saline (1 ml/kg/h, 0.9% sodium chloride) was given for 3-12 h before and 24 h after contrast exposure to the hydration group. CI-AKI was defined as the increase in serum creatinine values 0.5 mg/dl or 25% between 48 and 72 h after the invasive procedures. In our study, the incidence of CI-AKI development in the routine hydration group (7.1%) was significantly lower than in the nonhydration group (14.1%) (P: 0.02). This study revealed that older age, amount of contrast media, and routine hydration were independent risk factors for developing CI-AKI (P < 0.01, P: 0.04, P < 0.01, respectively). CONCLUSION We found that preprocedural and postprocedural intravenous hydration therapy reduces the development of CI-AKI in patients with NSTEMI at low risk for CI-AKI. We suggest administering routine hydration therapy in all ACS patients regardless of eGFR values.
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Effect of Early Balanced Crystalloids Before ICU Admission on Sepsis Outcomes.
Jackson, KE, Wang, L, Casey, JD, Bernard, GR, Self, WH, Rice, TW, Semler, MW, ,
Chest. 2021;(2):585-595
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BACKGROUND Studies suggest that using balanced crystalloids (lactated Ringer's solution or Plasma-Lyte A) rather than saline (0.9% sodium chloride) may improve outcomes for patients with sepsis in the ED and ICU. RESEARCH QUESTION What is the relative impact on sepsis outcomes of fluid composition during early resuscitation in the ED vs after ICU admission? STUDY DESIGN AND METHODS We performed a secondary analysis of the Isotonic Solutions and Major Adverse Renal Events Trial (SMART) data set, examining medical ICU patients with a diagnosis of sepsis (n = 1,641). SMART was a cluster-crossover trial comparing balanced crystalloids vs saline among critically ill adults. During the first 7 months of SMART, fluid choice was controlled only in the ICU ("ICU-only period"). In the final 15 months, fluid choice was coordinated between the ED and ICU ("ED and ICU period"). We performed logistic regression modeling for 30-day in-hospital mortality with an interaction term between randomized group (balanced crystalloids vs saline) and study period (ICU-only period vs ED and ICU period). RESULTS Three hundred and sixty-seven patients with sepsis were enrolled during the ICU-only period and 1,274 were enrolled during the ED and ICU period. Thirty-day in-hospital mortality occurred in 47 of 142 patients (33.1%) in the balanced crystalloid group vs 74 of 225 patients (32.9%) in the saline group during the ICU-only period (OR, 1.14; 95% CI, 0.70-1.88) and in 170 of 682 patients (24.9%) in the balanced crystalloid group vs 181 of 592 patients (30.6%) in the saline group in the ED and ICU period (OR, 0.68; 95% CI, 0.52-0.89) (P value for interaction, .07), consistent with a beneficial effect of balanced crystalloid primarily in the ED and ICU period. INTERPRETATION Among patients with sepsis, the effect of balanced crystalloids vs saline on mortality was greater among patients for whom fluid choice was controlled starting in the ED compared with starting in the ICU.
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Aggressive fluid hydration plus non-steroidal anti-inflammatory drugs versus non-steroidal anti-inflammatory drugs alone for post-endoscopic retrograde cholangiopancreatography pancreatitis (FLUYT): a multicentre, open-label, randomised, controlled trial.
Sperna Weiland, CJ, Smeets, XJNM, Kievit, W, Verdonk, RC, Poen, AC, Bhalla, A, Venneman, NG, Witteman, BJM, da Costa, DW, van Eijck, BC, et al
The lancet. Gastroenterology & hepatology. 2021;(5):350-358
Abstract
BACKGROUND Pancreatitis is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP). Prophylactic rectal administration of non-steroidal anti-inflammatory drugs (NSAIDs) is considered as standard of care to reduce the risk of post-ERCP pancreatitis. It has been suggested that aggressive hydration might further reduce this risk. Guidelines already recommend aggressive hydration in patients who are unable to receive rectal NSAIDs, although it is laborious and time consuming. We aimed to evaluate the added value of aggressive hydration in patients receiving prophylactic rectal NSAIDs. METHODS FLUYT, a multicentre, open-label, randomised, controlled trial done across 22 Dutch hospitals, included patients aged between 18 and 85 years with moderate to high risk of post-ERCP pancreatitis. Patients were randomly assigned (1:1) by a web-based module with varying block sizes to a combination of aggressive hydration and rectal NSAIDs (100 mg diclofenac or indomethacin; aggressive hydration group) or rectal NSAIDs (100 mg diclofenac or indomethacin) alone (control group). Randomisation was stratified according to treatment centre. Aggressive hydration comprised 20 mL/kg intravenous Ringer's lactate solution within 60 min from the start of ERCP, followed by 3 mL/kg per h for 8 h. The control group received normal intravenous saline with a maximum of 1·5 mL/kg per h and 3 L per 24 h. The primary endpoint was post-ERCP pancreatitis and was analysed on a modified intention-to-treat basis (including all patients who underwent randomisation and an ERCP and for whom data regarding the primary outcome were available). The trial is registered with the ISRCTN registry, ISRCTN13659155. FINDINGS Between June 5, 2015, and June 6, 2019, 826 patients were randomly assigned, of whom 388 in the aggressive hydration group and 425 in the control group were included in the modified intention-to-treat analysis. Post-ERCP pancreatitis occurred in 30 (8%) patients in the aggressive hydration group and in 39 (9%) patients in the control group (relative risk 0·84, 95% CI 0·53-1·33, p=0·53). There were no differences in serious adverse events, including hydration-related complications (relative risk 0·99, 95% CI 0·59-1·64; p=1·00), ERCP-related complications (0·90, 0·62-1·31; p=0·62), intensive care unit admission (0·37, 0·07-1·80; p=0·22), and 30-day mortality (0·95, 0·50-1·83; p=1·00). INTERPRETATION Aggressive periprocedural hydration did not reduce the incidence of post-ERCP pancreatitis in patients with moderate to high risk of developing this complication who routinely received prophylactic rectal NSAIDs. Therefore, the burden of laborious and time-consuming aggressive periprocedural hydration to further reduce the risk of post-ERCP pancreatitis is not justified. FUNDING Netherlands Organisation for Health Research and Development and Radboud University Medical Center.
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Comparison of aggressive versus standard intravenous hydration for clinical improvement among patients with mild acute pancreatitis: A randomized controlled trial.
Angsubhakorn, A, Tipchaichatta, K, Chirapongsathorn, S
Pancreatology : official journal of the International Association of Pancreatology (IAP) ... [et al.]. 2021;(7):1224-1230
Abstract
BACKGROUND Controversy remains regarding fluid management strategy, optimal volume and rate of intravenous fluid in mild acute pancreatitis. We performed a randomized controlled trial to compare clinical improvement and inflammatory markers between aggressive and standard fluid management. METHODS A single center prospective randomized controlled trial was conducted in a tertiary care hospital. We randomized patients with a diagnosis of mild acute pancreatitis using revised Atlanta classification in two groups, the aggressive (20 ml/kg bolus followed by 3 ml/kg/hr) and standard (10 ml/kg bolus followed by 1.5 ml/kg/hr) intravenous hydration with Lactated Ringer's solution. Primary outcome was clinical improvement at 24 and 36 hours. RESULTS The mean age of patients was 46 years and 34 patients (77%) were male. The average volumes of fluid during the first 24 hours in aggressive and standard groups was 4886 ml (71 ml/kg) and 3985 ml (53 ml/kg), respectively; p-value 0.002. Aggressive intravenous hydration did not significantly improve clinical outcome compared with standard intravenous hydration (45.45% vs. 31.82%, respectively; p-value 0.353). However, subgroup analysis between patients with obese and non-obese status, revealed aggressive intravenous hydration significantly improved clinical outcome within the first 24 hours in obese group. CONCLUSION Aggressive intravenous hydration with Lactated Ringer's solution did not improve clinical outcome in mild acute pancreatitis but showed statistically significant improvement only in patients with obese status. Future studies should include a larger sample size to confirm these findings.
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Risk of Electrolyte Disorders in Acutely Ill Children Receiving Commercially Available Plasmalike Isotonic Fluids: A Randomized Clinical Trial.
Lehtiranta, S, Honkila, M, Kallio, M, Paalanne, N, Peltoniemi, O, Pokka, T, Renko, M, Tapiainen, T
JAMA pediatrics. 2021;(1):28-35
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IMPORTANCE The use of isotonic fluid therapy is currently recommended in children, but there is limited evidence of optimal fluid therapy in acutely ill children. OBJECTIVE To evaluate the risk for electrolyte disorders, including hyponatremia, hypernatremia, and hypokalemia, and the risk of fluid retention in acutely ill children receiving commercially available plasmalike isotonic fluid therapy. DESIGN, SETTING, AND PARTICIPANTS This unblinded, randomized clinical pragmatic trial was conducted at the pediatric emergency department of Oulu University Hospital, Finland, from October 3, 2016, through April 15, 2019. Eligible study subjects (N = 614) were between 6 months and 12 years of age, required hospitalization due to an acute illness, and needed intravenous fluid therapy. Exclusion criteria included a plasma sodium concentration of less than 130 mmol/L or greater than 150 mmol/L on admission; a plasma potassium concentration of less than 3.0 mmol/L on admission; clinical need of fluid therapy with 10% glucose solution; a history of diabetes, diabetic ketoacidosis, or diabetes insipidus; a need for renal replacement therapy; severe liver disease; pediatric cancer requiring protocol-determined chemotherapy hydration; and inborn errors of metabolism. All outcomes and samples size were prespecified except those clearly marked as exploratory post hoc analyses. All analyses were intention to treat. INTERVENTIONS Acutely ill children were randomized to receive commercially available plasmalike isotonic fluid therapy (140 mmol/L of sodium and 5 mmol/L potassium in 5% dextrose) or moderately hypotonic fluid therapy (80 mmol/L sodium and 20 mmol/L potassium in 5% dextrose). MAIN OUTCOMES AND MEASURES The primary outcome was the proportion of children with any clinically significant electrolyte disorder, defined as hypokalemia less than 3.5 mmol/L, hypernatremia greater than 148 mmol/L, or hyponatremia less than 132 mmol/L during hospitalization due to acute illness. The main secondary outcomes were the proportion of children with severe hypokalemia and weight change. RESULTS There were 614 total study subjects (mean [SD] age, 4.0 [3.1] years; 315 children were boys [51%] and all 614 were Finnish speaking [100%]). Clinically significant electrolyte disorder was more common in children receiving plasmalike isotonic fluid therapy (61 of 308 patients [20%]) compared with those receiving moderately hypotonic fluid therapy (9 of 306 patients [2.9%]; 95% CI of the difference, 12%-22%; P < .001). The risk of developing electrolyte disorder was 6.7-fold greater in children receiving isotonic fluid therapy. Hypokalemia developed in 57 patients (19%) and hypernatremia developed in 4 patients (1.3%) receiving plasmalike isotonic fluid therapy. Weight change was greater in children receiving isotonic, plasmalike fluid therapy compared with those receiving mildly hypotonic fluids (mean weight gain, 279 vs 195 g; 95% CI, 16-154 g; P = .02). CONCLUSIONS AND RELEVANCE In this randomized clinical trial, commercially available plasmalike isotonic fluid therapy markedly increased the risk for clinically significant electrolyte disorders, mostly due to hypokalemia, in acutely ill children compared with previously widely used moderately hypotonic fluid therapy containing 20 mmol/L of potassium. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT02926989.
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Goal-directed fluid therapy in emergency abdominal surgery: a randomised multicentre trial.
Aaen, AA, Voldby, AW, Storm, N, Kildsig, J, Hansen, EG, Zimmermann-Nielsen, E, Jensen, KM, Tibæk, P, Mortensen, A, Møller, AM, et al
British journal of anaesthesia. 2021;(4):521-531
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BACKGROUND More than 50% of patients have a major complication after emergency gastrointestinal surgery. Intravenous (i.v.) fluid therapy is a life-saving part of treatment, but evidence to guide what i.v. fluid strategy results in the best outcome is lacking. We hypothesised that goal-directed fluid therapy during surgery (GDT group) reduces the risk of major complications or death in patients undergoing major emergency gastrointestinal surgery compared with standard i.v. fluid therapy (STD group). METHODS In a randomised, assessor-blinded, two-arm, multicentre trial, we included 312 adult patients with gastrointestinal obstruction or perforation. Patients in the GDT group received i.v. fluid to near-maximal stroke volume. Patients in the STD group received i.v. fluid following best clinical practice. Postoperative target was 0-2 L fluid balance. The primary outcome was a composite of major complications or death within 90 days. Secondary outcomes were time in intensive care, time on ventilator, time in dialysis, hospital stay, and minor complications. RESULTS In a modified intention-to-treat analysis, we found no difference in the primary outcome between groups: 45 (30%) (GDT group) vs 39 (25%) (STD group) (odds ratio=1.24; 95% confidence interval, 0.75-2.05; P=0.40). Hospital stay was longer in the GDT group: median (inter-quartile range), 7 (4-12) vs 6 days (4-8.5) (P=0.04); no other differences were found. CONCLUSION Compared with pressure-guided i.v. fluid therapy (STD group), flow-guided fluid therapy to near-maximal stroke volume (GDT group) did not improve the outcome after surgery for bowel obstruction or gastrointestinal perforation but may have prolonged hospital stay. CLINICAL TRIAL REGISTRATION EudraCT number 2015-000563-14; the Danish Scientific Ethics Committee and the Danish Data Protection Agency (REG-18-2015).
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Hypertension during Diabetic Ketoacidosis in Children.
DePiero, A, Kuppermann, N, Brown, KM, Schunk, JE, McManemy, JK, Rewers, A, Stoner, MJ, Tzimenatos, L, Garro, A, Myers, SR, et al
The Journal of pediatrics. 2020;:156-163.e5
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OBJECTIVES To characterize hemodynamic alterations occurring during diabetic ketoacidosis (DKA) in a large cohort of children and to identify clinical and biochemical factors associated with hypertension. STUDY DESIGN This was a planned secondary analysis of data from the Pediatric Emergency Care Applied Research Network Fluid Therapies Under Investigation in DKA Study, a randomized clinical trial of fluid resuscitation protocols for children in DKA. Hemodynamic data (heart rate, blood pressure) from children with DKA were assessed in comparison with normal values for age and sex. Multivariable statistical modeling was used to explore clinical and laboratory predictors of hypertension. RESULTS Among 1258 DKA episodes, hypertension was documented at presentation in 154 (12.2%) and developed during DKA treatment in an additional 196 (15.6%), resulting in a total of 350 DKA episodes (27.8%) in which hypertension occurred at some time. Factors associated with hypertension at presentation included more severe acidosis, (lower pH and lower pCO2), and stage 2 or 3 acute kidney injury. More severe acidosis and lower Glasgow Coma Scale scores were associated with hypertension occurring at any time during DKA treatment. CONCLUSIONS Despite dehydration, hypertension occurs in a substantial number of children with DKA. Factors associated with hypertension include greater severity of acidosis, lower pCO2, and lower Glasgow Coma Scale scores during DKA treatment, suggesting that hypertension might be centrally mediated.