Safety and Efficacy of Urea for Hyponatremia

2021 ◽  
pp. 001857872110375
Author(s):  
William M. Hammonds ◽  
Ellen A. Keating ◽  
Megan E. Smetana ◽  
Keaton S. Smetana ◽  
Megan M. Bond
Keyword(s):  
Serum Sodium ◽  
Retrospective Cohort ◽  
Primary Outcome ◽  
Median Dose ◽  
Safety And Efficacy ◽  
Median Serum ◽  
Patient Tolerance ◽  
Significant Difference ◽  
Prior Use ◽  
Serum Blood Urea Nitrogen

Background and Objective: Urea is an alternative for treatment of hyponatremia however, its use has not been widely studied. The purpose of this study was to evaluate the safety and efficacy of urea for the treatment of hyponatremia. Methods: A retrospective cohort of patients with hyponatremia (serum sodium <135 mEq/L) of any cause who received at least 1 dose of urea during hospitalization and no prior use of urea. Serum sodium levels were collected at baseline and for 4 days or until urea was discontinued, whichever occurred first. The primary outcome was the serum sodium change between baseline and discharge or urea discontinuation. Results: Median serum sodium increased 2 [IQR, 0-4] mEq/L per day after urea administration at a median dose of 30 g/day. A significant difference in serum sodium was observed between baseline and discharge or discontinuation (124.2 ± 4 vs 130.1 ± 5.1; P < .001) and serum blood urea nitrogen (BUN) levels (18.4 ± 13.1 vs 41.1 ± 26.6; P ≤ .001). Serum sodium overcorrection (increase >8 mEq/L in 24 hours) occurred in 6 patients (8%). Urea was discontinued in 39 patients (53%); 20 discontinuations were due to patient intolerance. Conclusion: Urea appears to be an effective treatment for hyponatremia; however, patient tolerance, the rate of serum sodium overcorrection, and outpatient affordability may limit its use.

Effectiveness and tolerability of oral versus subcutaneous methotrexate in patients with rheumatoid arthritis

Rheumatology ◽  
2021 ◽  
Author(s):  
Janne Heuvelmans ◽  
Nathan den Broeder ◽  
Geke A H van den Elsen ◽  
Alfons A den Broeder ◽  
Bart J F van den Bemt
Keyword(s):  
Rheumatoid Arthritis ◽  
Retrospective Cohort ◽  
Primary Outcome ◽  
Real Life ◽  
Treat To Target ◽  
Oral Methotrexate ◽  
Real Life Setting ◽  
Significant Difference ◽  
The Mean ◽  
Secondary Outcomes

Abstract Objectives The aim of this study was to compare the effectiveness and tolerability between oral methotrexate (MTX) and subcutaneous MTX in a large group of rheumatoid arthritis (RA) patients in a real-life setting. Methods In this retrospective cohort study, adult patients with clinical diagnosis of RA who started MTX treatment (monotherapy or combined with hydroxychloroquine), either started with oral or subcutaneous MTX. The primary outcome was superiority testing of between group difference in change in DAS28CRP between baseline and 3–6 months, and subsequent non inferiority testing (NI margin 0.6) analyses in case of non-superiority. Secondary outcomes included MTX dose, side effects, laboratory abnormalities, and use of comedication. Results 640 RA patients were included: 259 started with oral MTX and 381 with subcutaneous. There was no significant difference in ΔDAS28CRP, after adjusting for confounding, 0.13 (95%-CI: -0.14, 0.40), and oral MTX strategy was non inferior to subcutaneous. The mean MTX dose was slightly lower for the oral strategy (18.0 SD6.9 vs 19.9 SD8.2, p= 0.002), which was accompanied by a lower cumulative incidence of adverse events (41% vs 52%, p= 0.005). No differences were seen in use of other comedication. Conclusions Starting with oral MTX in RA in a real-life setting is non inferior to a subcutaneous MTX treatment with regard to disease activity control, at least when used in dosages up to 25 mg and on a background of HCQ cotreatment and a treat-to-target approach. In addition, tolerability was better. This supports the strategy of starting with oral MTX.

The effect of an oxytocin washout period on blood loss at cesarean delivery

2020 ◽  
Vol 48 (8) ◽  
pp. 799-802
Author(s):  
Elizabeth Cochrane ◽  
Ashley Huber ◽  
Christopher Jou ◽  
Joseph Chappelle
Keyword(s):  
Blood Loss ◽  
Cesarean Delivery ◽  
Retrospective Cohort ◽  
Primary Outcome ◽  
Rest Period ◽  
Demographic Characteristics ◽  
Significant Difference ◽  
Gestational Age At Delivery ◽  
Oxytocin Augmentation ◽  
Primary Cesarean Delivery

AbstractObjectivesProlonged oxytocin exposure may result in increased blood loss during delivery. Our objective was to determine whether an oxytocin rest period before cesarean delivery had an impact on blood loss.MethodsWe performed a retrospective cohort study of women who underwent primary cesarean delivery after oxytocin augmentation. The primary outcome was change between pre- and postoperative hematocrit (Hct) in women with less than 60-min oxytocin rest period (<60 min) and greater than 60-min rest period (>60 min).ResultsThere was no difference in demographic characteristics (age, BMI, or gestational age at delivery) between the two groups. Women in the >60 min group had a higher cumulative dose and longer duration of oxytocin administration. There was no significant difference in change in Hct between the two groups when controlling for these factors.ConclusionsWe did not find a significant correlation between the duration of the oxytocin rest period and blood loss. Oxytocin washout periods of greater than 60 min may not result in decreased blood loss at cesarean delivery, and thus, women may not benefit from such oxytocin washout periods.

The Safety and Efficacy of Desmopressin in Patients With Intracranial Hemorrhage and a History of Alcohol Use

2021 ◽  
pp. 088506662110314
Author(s):  
Michelle Gunther ◽  
Corey J. Witenko ◽  
Morgan Prust ◽  
David Salerno ◽  
Karen Berger
Keyword(s):  
Platelet Aggregation ◽  
Alcohol Use ◽  
Intracranial Hemorrhage ◽  
Serum Sodium ◽  
Retrospective Chart Review ◽  
Hematoma Expansion ◽  
Safety And Efficacy ◽  
Increased Risk ◽  
Significant Difference ◽  
History Of

Background: Patients with a history of alcohol use disorder are at an increased risk of hematoma expansion following intracranial hemorrhage (ICH) due to the effects of alcohol on platelet aggregation. Desmopressin (DDAVP) improves platelet aggregation and may decrease hematoma expansion in patients with ICH. However, DDAVP may also increase the risk of hyponatremia and thrombotic events. Evidence is limited regarding the safety and efficacy of DDAVP in alcohol use (AU)-associated ICH. Methods: This was a retrospective chart review of adult patients with radiographic evidence of ICH and a confirmed or suspected history of alcohol use upon admission. Patients were categorized into groups based on DDAVP administration. Safety outcomes included hyponatremia (serum sodium <135 mEq/L or decrease in serum sodium of ≥ 5 mEq/L for patients with baseline sodium <135 mEq/L) within 24 hours of ICH and thrombotic events within 7 days of ICH. The primary efficacy outcome was the incidence of hematoma expansion, defined as any expansion of the hemorrhage noted on repeat imaging within 32 hours. Results: In total, 52 patients were included in the safety analysis (27 DDAVP and 25 non-DDAVP). Although hyponatremia was numerically higher in the DDAVP group, there was no significant difference between groups (19.2% vs 4.2%, P = 0.192). Thrombotic complications were similar between the DDAVP and non-DDAVP groups (11.1% vs. 8%, P = 1.0). Thirty-nine patients met criteria for hemostatic efficacy analysis. There was no difference in hematoma expansion between the DDAVP and non-DDAVP groups (23.1% vs 34.6%, P = 0.71) and these findings were consistent after adjusting for differences in baseline characteristics (OR 0.63, 95% CI 0.1-3.3). Conclusion: The administration of DDAVP was not associated with adverse safety events, but did not significantly reduce the incidence of hematoma expansion in patients with AU-associated ICH.

scholarly journals Comparison of Efficacy and Safety between Long-Acting Injectable Antipsychotic Monotherapy and Combination of Long-Acting Injectable and Oral Antipsychotics in Patients with Schizophrenia

2021 ◽  
Vol 2021 ◽  
pp. 1-6
Author(s):  
Thanompong Sathienluckana ◽  
Pornyupa Tiangpattanawong ◽  
Karnpreena Chaiyasukthananoan ◽  
Pannapat Jittayanan ◽  
Hathaipat Sawetwangsing ◽  
...  
Keyword(s):  
Cohort Study ◽  
Clinical Practice ◽  
Retrospective Cohort ◽  
Primary Outcome ◽  
Monotherapy Group ◽  
Efficacy And Safety ◽  
Drug Reactions ◽  
Significant Difference ◽  
Oral Antipsychotic ◽  
Long Acting

Background. Long-acting injectable (LAI) antipsychotics are used as a monotherapy in patients with schizophrenia. However, the combination of LAI and oral antipsychotics is commonly used in clinical practice, despite there being very limited studies investigating the efficacy and safety of this combination compared with LAI antipsychotic monotherapy. Objective. To study the efficacy and safety of LAI antipsychotic monotherapy compared with the combination of LAI and oral antipsychotics in patients with schizophrenia. Methods. This study was a retrospective cohort study, which classified eligible patients into two groups: the LAI antipsychotic monotherapy group and the combination of LAI and oral antipsychotic group. The primary outcome was hospitalization between groups. The duration of the study was 2 years. Results. In total, 86 patients completed the study and were analysed (LAI antipsychotic monotherapy group: n = 25 ; combination of LAI and oral antipsychotic group: n = 61 ). There was no significant difference in hospitalization between the two groups ( P = 1.000 ). For other outcomes, there were also no significant differences in both all-cause discontinuation ( P = 0.667 ) and adverse drug reactions ( P = 0.732 ) between the two groups. Conclusion. The efficacy and safety of LAI antipsychotic monotherapy appeared similar to the combination of LAI and oral antipsychotics in patients with schizophrenia. Therefore, the combination of LAI and oral antipsychotics, which is commonly used in clinical practice, may not be necessary.

scholarly journals Clonidine for the Treatment of Agitation After Dexmedetomidine Discontinuation in Pediatric Patients: A Retrospective Cohort Study

2021 ◽  
Vol 26 (8) ◽  
pp. 821-827
Author(s):  
Thao L. Nguyen ◽  
Weng Man Lam ◽  
Hillary Orr ◽  
Brian Gulbis ◽  
Riza Mauricio ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Cohort Study ◽  
Retrospective Cohort Study ◽  
Retrospective Cohort ◽  
Primary Outcome ◽  
Pediatric Patients ◽  
Group Versus ◽  
Significant Difference ◽  
Scoring Tool ◽  
Dexmedetomidine Infusion

OBJECTIVE Dexmedetomidine has become a widely used drug in PICUs for sedation. We aim to determine the effects of clonidine on pediatric patients after dexmedetomidine use. METHODS This was a retrospective cohort study that evaluated all pediatric patients admitted to a tertiary PICU who received dexmedetomidine infusion for &gt;48 hours. Outcomes in patients exposed to clonidine (CLON) were compared with those of patients who were not exposed (NoCLON). RESULTS A total of 216 patients were included in this study (43 CLON and 173 NoCLON). The primary outcome, agitation, was less in the CLON cohort (9.3%) than in the NoCLON cohort (9.3% versus 29.5%, respectively; p &lt; 0.01). Hospital LOS was longer in the CLON group (59 versus 20 days, p &lt; 0.01), as was PICU LOS (37.4 versus 11.1 days, p &lt; 0.01). There was no significant difference in the occurrence of increased heart rate or blood pressure between the 2 cohorts. Patients exposed to concurrent midazolam and opioid infusions had higher incidence of agitation when they did not receive clonidine (CLON 8% versus NoCLON 37%, OR 0.15; 95% CI, 0.05–0.51; p &lt; 0.01). In contrast, there was no difference in the incidence of agitation for the CLON group versus the NoCLON group when dexmedetomidine was administered alone (25% versus 19%, OR 1.4; p = 0.99). CONCLUSIONS Our study confirms the importance and effectiveness of clonidine to treat agitation after dexmedetomidine discontinuation. A validated withdrawal scoring tool can help better define dexmedetomidine withdrawal in pediatric patients.

Abstract P27: Safety and Efficacy of Alteplase in Ischemic Stroke Patients > 80 Years of Age in the Extended Time Window

Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Christoph Stretz ◽  
Brian C Mac Grory ◽  
Nasir Fakhri ◽  
Anusha Boyanpally ◽  
Syed Daniyal Asad ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Functional Outcome ◽  
Primary Outcome ◽  
Intravenous Thrombolysis ◽  
Stroke Severity ◽  
Stroke Patients ◽  
Safety And Efficacy ◽  
Good Functional Outcome ◽  
Significant Difference ◽  
Intravenous Alteplase

Background: While patients > 80 years of age were originally excluded from the ECASS 3 trial showing benefit in the 3 – 4.5-hour window, recent studies have shown that intravenous alteplase is safe and benefits this population. We aimed to assess safety and efficacy of intravenous thrombolysis in stroke patients above 80 presenting both in the 3 and 3 – 4.5-hour windows. Methods: We analyzed data from 3 comprehensive stroke centers in the US of consecutive patients > 80 years of age presenting with acute ischemic stroke who received intravenous alteplase in both the 3 and 4.5-hour time windows over a 3-year period. We collected baseline demographic data, stroke severity as assessed by NIHSS scores, and use of mechanical thrombectomy (MT). Primary outcome was symptomatic intracerebral hemorrhage, as defined by ECASS 2 criteria (hemorrhagic transformation post thrombolysis with worsening of NIHSS score by ≥ 4 points). Secondary outcomes included assessment of efficacy, evaluated by good functional outcome (mRS 0 – 2) at time of discharge. Results: We identified 418 patients with ischemic stroke above 80 years (64.8% women) who received alteplase: 344 (82.3%) within 3 hour and 74 (17.7%) in the 3 to 4.5-hour window, with similar stroke severity by NIHSS scores (median [IQR] 13 [12-32] vs. 12 [6-20], p = 0.87). In addition, 147 patients received MT, 128 (37.2%) versus 19 (25.7%), (p= 0.059) in the 3 and 3-4.5-hour groups. The overall rate of sICH was 6.1% and 4.0% (p = 0.49), in the 3 and 3-4.5-hour groups, respectively. Good functional outcome was achieved in 16.7% at time of discharge, for 17.7% in the 3-hour group and for 12.2% in the 3 – 4.5-hour group (p= 0.24). Conclusions: In our multi-center cohort, the use of alteplase in patients above 80 was safe, with low sICH rates similar to the literature, irrespective of age. Given the rare occurrence of our primary outcome in a selected cohort of acute stroke patients, our study was not powered to detect a possible significant difference in sICH.

scholarly journals Intravenous Immunoglobulin-based Adjuvant Therapy for Severe COVID-19: a Single-center Retrospective Cohort Study

2021 ◽  
Author(s):  
Xiao Hou ◽  
Li Tian ◽  
Lei Zhou ◽  
Xinhua Jia ◽  
Li Kong ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Cohort Study ◽  
Adjuvant Therapy ◽  
Hospital Stay ◽  
Retrospective Cohort ◽  
Primary Outcome ◽  
Length Of Hospital Stay ◽  
Confounding Factors ◽  
Single Center ◽  
Significant Difference

Abstract Objective Coronavirus disease 2019 (COVID-19) is a major challenge facing the world. Certain guidelines recommend intravenous immunoglobulin (IVIG) for adjuvant treatment of COVID-19. However, there is a lack of clinical evidence to support the use of IVIG.Methods This single-center retrospective cohort study included all adult patients with laboratory-confirmed severe COVID-19 in the Respiratory and Critical Care Unit of Dabie Mountain Regional Medical Center, China. Patient information, including demographic data, laboratory indicators, the use of glucocorticoids and IVIG, hospital mortality, the application of mechanical ventilation, and the length of hospital stay was collected. The primary outcome was the composite end point, including death and the use of mechanical ventilation. The secondary outcome was the length of hospital stay.Results Of the 285 patients with confirmed COVID-19, 113 severely ill patients were included in this study. Compared with the non-IVIG group, more patients in the IVIG group reached the composite end point [12 (25.5%) vs 5 (7.6%), P=0.008]. However, there was no statistically significant difference in the primary outcome between the two groups (P=0.167) after adjusting for confounding factors. Patients in the IVIG group had a longer hospital stay [23.0 (19.0-31.0) vs 16.0 (13.8-22.0), P<0.001]. After adjusting for confounding factors, there was still a statistically significant difference between the two groups (P=0.041).Conclusion Adjuvant therapy with IVIG did not improve the in-hospital mortality rate or the need for mechanical ventilation in patients with severe COVID-19. In contrast, the application of IVIG was related to a longer hospital stay.

Are neonatal outcomes of triplet pregnancies different from those of singletons according to gestational age?

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Georgios Mitsiakos ◽  
Dimitra Gialamprinou ◽  
Ilias Chatziioannidis ◽  
Abraham Pouliakis ◽  
Christos Georgios Kontovazainitis ◽  
...  
Keyword(s):  
Cohort Study ◽  
Gestational Age ◽  
Retrospective Cohort Study ◽  
Retrospective Cohort ◽  
Primary Outcome ◽  
Neonatal Morbidity ◽  
Neonatal Outcomes ◽  
Multiple Pregnancies ◽  
Extreme Prematurity ◽  
Significant Difference

ABSTRACT Objectives Multiple pregnancies sustain the high pace of extreme prematurity. Little evidence is available about triplet gestation given the evolution in their management during the last decades. The aim of the study was to compare the neonatal outcomes of triplets with those of matched singletons in a cohort study. Methods An observational retrospective cohort study of triplets and matched singletons born between 2004 and 2017 matched by gestational age was conducted. Additionally, the investigation performed in regard to data from the overall Greek population of interest. The primary outcome was mortality or severe neonatal morbidity based on pregnancy type. Results A total of 237 triplets of 24–36 weeks’ gestation and 482 matched singletons were included. No differences in the primary outcome between triplets and singletons were found. Rates of severe neonatal morbidities did not differ significantly between triplets and singletons. A threshold of 1000 gr for birthweight and 28 weeks’ gestation for gestational age determined survival on triplets [OR: 0.08 (95% CI: 0.02–0.40, p=0.0020) and OR: 0.13 (95% CI: 0.03–0.57, p=0.0020) for gestational age and birthweight respectively]. In Greece stillbirths in triplets was 8 times higher than that of singletons (OR: 8.5, 95% CI: 6.9–10.5). From 3,375 triplets, 94 were stillborn, whereas in singletons, 4,659 out of 1,388,273. In our center 5 times more triplets than the expected average in Greece were delivered with no significant difference in stillbirths’ rates. Conclusions No significant differences were identified in mortality or major neonatal morbidities between triplets and matched singletons highlighting the significance of prematurity and birthweight for these outcomes.

Nonunion Rates in Hind- and Midfoot Arthrodesis in Current, Ex-, and Nonsmokers

2020 ◽  
pp. 107110072097126
Author(s):  
Jack Allport ◽  
Jayasree Ramaskandhan ◽  
Malik S. Siddique
Keyword(s):  
Risk Factor ◽  
Cohort Study ◽  
Relative Risk ◽  
Retrospective Cohort Study ◽  
Retrospective Cohort ◽  
Smoking Status ◽  
Time Frame ◽  
Modifiable Risk Factor ◽  
Level Of Evidence ◽  
Significant Difference

Background: Nonunion rates in hind or midfoot arthrodesis have been reported as high as 41%. The most notable and readily modifiable risk factor that has been identified is smoking. In 2018, 14.4% of the UK population were active smokers. We examined the effect of smoking status on union rates for a large cohort of patients undergoing hind- or midfoot arthrodesis. Methods: In total, 381 consecutive primary joint arthrodeses were identified from a single surgeon’s logbook (analysis performed on a per joint basis, with a triple fusion reported as 3 separate joints). Patients were divided based on self-reported smoking status. Primary outcome was clinical union. Delayed union, infection, and the need for ultrasound bone stimulation were secondary outcomes. Results: Smoking prevalence was 14.0%, and 32.2% were ex-smokers. Groups were comparable for sex, diabetes, and body mass index. Smokers were younger and had fewer comorbidities. Nonunion rates were higher in smokers (relative risk, 5.81; 95% CI, 2.54-13.29; P < .001) with no statistically significant difference between ex-smokers and nonsmokers. Smokers had higher rates of infection ( P = .05) and bone stimulator use ( P < .001). Among smokers, there was a trend toward slower union with heavier smoking ( P = .004). Conclusion: This large retrospective cohort study confirmed previous evidence that smoking has a considerable negative effect on union in arthrodesis. The 5.81 relative risk in a modifiable risk factor is extremely high. Arthrodesis surgery should be undertaken with extreme caution in smokers. Our study shows that after cessation of smoking, the risk returns to normal, but we were unable to quantify the time frame. Level of Evidence: Level III, retrospective cohort study.

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