scholarly journals Effect of Prolonged-Release Pirfenidone on Renal Function in Septic Acute Kidney Injury Patients: A Double-Blind Placebo-Controlled Clinical Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-7
Author(s):  
Jonathan S. Chávez-Iñiguez ◽  
Jorge L. Poo ◽  
Miguel Ibarra-Estrada ◽  
Leonel García-Benavides ◽  
Guillermo Navarro-Blackaller ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Acute Kidney Injury ◽  
Adverse Events ◽  
Kidney Injury ◽  
Primary Objective ◽  
Controlled Clinical Trial ◽  
Prolonged Release ◽  
Double Blind ◽  
Septic Acute Kidney Injury ◽  
The Mean

Background. There is no treatment for septic acute kidney injury (sAKI). The anti-inflammatory activity of prolonged-release pirfenidone (PR-PFD) could be beneficial in this clinical setting. Methods. This study was a double-blind randomized clinical trial in sAKI patients with nephrology consultation at the Civil Hospital of Guadalajara, in addition to the usual treatment of AKI associated with sepsis; patients were randomized to receive either PR-PFD at 1,200 mg/day (group A) or 600 mg/day (group B) or a matched placebo for 7 consecutive days. The primary objective was the decrease in serum creatinine (sCr) and increase in urinary volume (UV); the secondary objectives were changes in serum electrolytes, acid-base status, and mortality. Results. Between August 2016 and August 2017, 88 patients were randomized. The mean age was 54 (17 ± SD) years, and 47% were male. The main site of infection was the lung (39.8%), septic shock was present in 39.1% of the cases, and the mean SOFA score was 8.8 points. 28 patients received PFD 1,200 mg, 30 patients received PFD 600 mg, and 30 patients received placebo. During the study, sCr did not differ among the groups. The reversion rate of sCr, UV, and mortality was not different among the groups ( p = 0.70 , p = 0.47 , and p = 0.38 , respectively). Mild adverse events were not different among the groups. Conclusion. PR-PFD did not improve the clinical course of sAKI and seemed to be safe in terms of adverse events. This trial is registered with NCT02530359.

scholarly journals A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial of High-Dose, Short-Term Vitamin D Administration in the Prevention of Acute Kidney Injury after Cardiac Surgery

2021 ◽  
pp. 1-7
Author(s):  
Pegah Eslami ◽  
Manouchehr Hekmat ◽  
Mahmoud Beheshti ◽  
Ramin Baghaei ◽  
Seyed Mohsen Mirhosseini ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Vitamin D ◽  
Acute Kidney Injury ◽  
Cardiac Surgery ◽  
Kidney Injury ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
High Dose ◽  
Double Blind ◽  
Postoperative Aki

<b><i>Background:</i></b> Acute kidney injury (AKI) after cardiac surgery is a relatively common complication affecting short- and long-term survival. The renoprotective effect of vitamin D (VitD) has been confirmed in several experimental models. This study was conducted to evaluate the effect of high-dose VitD administration in patients with VitD insufficiency on the incidence of postoperative AKI, the urinary level of tubular biomarkers, and serum anti-inflammatory biomarker after coronary artery bypass graft. <b><i>Design and Method:</i></b> In this randomized double-blind controlled clinical trial, the patients were randomly allocated to either the VitD group (<i>n</i> = 50), receiving 150,000 IU VitD tablets daily for 3 consecutive days before surgery or the control group (<i>n</i> = 61), receiving placebo tablets. <b><i>Results:</i></b> There was no difference in the incidence of postoperative AKI between the groups. Both of the urinary levels of interleukin-18 and kidney injury molecule-1 were significantly increased after the operation (<i>p</i> &#x3c; 0.001, for both). Also, the serum level of interleukin-10 was increased after 3 days of VitD supplementation (<i>p</i> = 0.001). In comparison with the control group, it remained on a higher level after the operation (<i>p</i> &#x3c; 0.001) and the next day (<i>p</i> = 0.03). The patients with AKI had more postoperative bleeding and received more blood transfusion. <b><i>Conclusion:</i></b> VitD pretreatment was unable to impose any changes in the incidence of AKI and the urinary level of renal biomarkers. However, high-dose administration of VitD may improve the anti-inflammatory state before and after the operation. Further studies are needed to assess the renoprotective effect of VitD on coronary surgery patients.

scholarly journals Efficacy of two siddha polyherbal decoctions, Nilavembu Kudineer and Kaba Sura Kudineer, along with standard allopathy treatment in the management of mild to moderate symptomatic COVID-19 patients—a double-blind, placebo-controlled, clinical trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Anurag Srivastava ◽  
Manickavasagam Rengaraju ◽  
Saurabh Srivastava ◽  
Vimal Narayanan ◽  
Vivek Gupta ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Viral Load ◽  
Adverse Events ◽  
Hospital Stay ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Function Test ◽  
Stay Time ◽  
The Mean

Abstract Background and aim Globally, the ongoing pursuit in exploring an effective drug to combat severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) virus has not met with significant success to date. Indian traditional medicines, especially polyherbal formulations like Nilavembu Kudineer (NVK) and Kaba Sura Kudineer (KSK) of the Siddha system of medicine, have been used as public health interventions for controlling viral epidemics like dengue and Chikungunya. These traditional therapies have been found safe, effective, and widely accepted. The current study evaluates the comparative efficacy of NVK and KSK as opposed to the placebo, in the management of mild to moderate COVID-19 disease. Methods The study was a double-blind, placebo-controlled comparative clinical trial, with the primary objective of determining the efficacy of KSK and NVK. Patients (n=125) diagnosed with mild to moderate COVID-19 symptoms were enrolled in the study over a period of 4 months (Aug 2020—Dec 2020). Participants were randomized into 3 arms; placebo-decaffeinated tea in Arm I, NVK in Arm II, and KSK in Arm III. Each arm received 60 ml of the respective treatment twice a day, post morning and evening meals, along with standard allopathy treatment for a maximum of 10 days. The main outcome measures of the study were the reduction in SARS-CoV-2 viral load, hospital stay, and time taken by the patients to become asymptomatic from symptomatic. Efficacy assessments included clinical symptoms (fever, cough, and breathlessness) each day and real-time reverse transcription-polymerase chain reaction (RT-PCR), liver function test (LFT), renal function test (RFT), and electrolytes and electrocardiogram (ECG) at baseline (day 0) and days 3, 6, and 10. Post-treatment, participants were followed up for 30 days via phone for adverse effects if any. Effects of drugs on inflammatory markers (IL6) at the end of treatment were also recorded. Adverse events (AE) were monitored throughout the study. Results The results revealed that when compared to patients in the placebo arm, those in NVK and KSK arms showed a statistically significant reduction in hospital stay time, reduction in viral load of SARS-CoV-2, and the time taken to become symptomatic from asymptomatic. Out of 125 COVID-19 patients recruited, 120 completed the study; two from the placebo group developed severe symptoms and were shifted to the intensive care unit (ICU) and three patients from Arms II and III withdrew from the study. The mean age of females (n=60) and males (n=60) enrolled was between 40.2 and 44.3 years, respectively. Results were more promising for all the patients in NVK and KSK arms as all enrolled participants (100%) under this group got discharged by day 6 as compared to only 42.5% (n=17) from the placebo group on that day. The hospital stay time for patients in Arm I was significantly longer (mean [SD]=8.4 [2.0] days) as compared to the Arms II and III (mean [SD]=4.7 [1.5] and 4.2 [1.5] days, respectively (Kruskal-Wallis test, P=0.0001). Patients in the three groups took a significantly different number of days to become asymptomatic. While Arm II and III patients took mean of 2.5 and 1.7 days, respectively, Arm I, patients took a mean of 4.2 days (Kruskal-Wallis test, P=0.0001). In all, two adverse events were recorded, one for vomiting and one for diarrhea lasting a day in Arm I and Arm II, respectively. The mean value of interleukin-6 (IL6) was significantly different in comparison to the placebo-decaffeinated tea arm (NVK=2.6 and KSK=2.2, placebo=4.0, P=0.02). The other blood biochemical parameters like C-reactive protein (CRP), lactate dehydrogenase (LDH), ferritin, and D-dimer that were analyzed at the baseline and at the time of discharge from the hospital, were not significantly different in the three arms. Conclusion NVK and KSK arms showed a statistically significant reduction in hospital stay time, reduction in viral load of SARS-CoV-2, and time taken for patients to become asymptomatic from symptomatic, when compared to the placebo (decaffeinated tea). The primary outcome measures of the KSK arm were significantly better than those in the NVK arm.

scholarly journals Evaluation of traditional initial vancomycin dosing versus utilizing an electronic AUC/MIC dosing program

2020 ◽  
Vol 18 (3) ◽  
pp. 2024
Author(s):  
Kerri A. McGrady ◽  
Makenzie Benton ◽  
Serina Tart ◽  
Riley Bowers
Keyword(s):  
Acute Kidney Injury ◽  
Adverse Events ◽  
Area Under The Curve ◽  
Kidney Injury ◽  
Vancomycin Dose ◽  
Trough Concentrations ◽  
The Mean ◽  
Trough Levels ◽  
Vancomycin Treatment ◽  
Background Area

Background: Area under the curve to minimum inhibitory concentration (AUC/MIC) has been recommended by the 2020 updated vancomycin guidelines for dosing vancomycin for both efficacy and safety. Previously, AUC/MIC has been cumbersome to calculate so surrogate trough concentrations of 15-20 mg/dL were utilized. However, trough-based dosing is not a sufficient surrogate as AUC/MIC targets of 400-600 can usually be reached without achieving troughs of 15-20 mg/dL. Targeting higher trough levels may also lead to adverse events including acute kidney injury (AKI) and nephrotoxicity. Objective: To compare the mean total first day vancomycin dose in traditional trough-based dosing versus dosing recommended by an AUC/MIC dosing program. Methods: Adult inpatients who received at least 24 hours of IV vancomycin treatment were included in this single-center, retrospective cohort study. The primary endpoint was difference in mean total first day vancomycin dose in milligrams (mg) received between patients’ traditional trough-based dosing and recommended dose via AUC/MIC electronic dosing calculator. Patients served as their own control by analyzing both actual dose received and dose recommended by the electronic AUC/MIC program. Rates of vancomycin induced adverse events, including acute kidney injury, elevated steady-state trough concentrations, and Red Man’s syndrome were also compared between patients who received doses consistent with the AUC/MIC dosing recommendation versus those who did not. Results: 264 patients were included in this study. Initial 24-hour vancomycin exposure was significantly lower with the recommended AUC/MIC dose versus the dose received (2380.7; SD 966.6 mg vs 2649.6; SD 831.8 mg, [95% CI 114.7:423.1] p=0.0007). Conclusions: Utilizing an electronic AUC/MIC vancomycin dosing calculator would result in lower total first day vancomycin doses.

scholarly journals Safety review of 42 cases of COVID-19 treated with low-dose chloroquine

2020 ◽  
Author(s):  
Bo Zhou ◽  
Jing Zhang ◽  
Yanqing Liu ◽  
Wenxin Hong ◽  
Fengbi Jian ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Events ◽  
Adverse Reactions ◽  
Low Dose ◽  
Information Management System ◽  
Controlled Clinical Trial ◽  
Global Pandemic ◽  
High Incidence ◽  
The Mean ◽  
Grade 3

Abstract BackgroundCoronavirus Disease 2019 (COVID-19) has become a global pandemic and caused over one hundred thousand death. Chloroquine (CQ) and hydroxychloroquine (HCQ) were recommended for off-label use in the treatment of COVID-19 in some countries despite their unclear benefit. However, the toxicity of these agents has been ignored, so the investigation of their safety in the treatment of COVID-19 is crucial for providing a reference for the rational use. MethodsThe medical records obtained from the information management system of Guangzhou Eighth People’s Hospital were reviewed to extract data about patients who received chloroquine phosphate tablets for COVID-19 treatment from January 20th to March 5th, 2020. The data were assessed to determine the correlation of adverse reaction with chloroquine phosphate based on Chinese CFDA standards as well as the severity of adverse events based on American CTCAE5.0 standard, and evaluate the safety of this medication.ResultsA total of 42 patients (23 males and 19 females, average 42.19±14.29 years old) with COVID-19 were treated with low-dose chloroquine phosphate (oral, 500 mg, once per day). Totally 18 patients（42.86%）experienced 20 adverse events. The mean duration of CQ administration was 6.57 days (SD, 3.16 days; range: 1 day to 16 days) and 52.4% received CQ for 7 to 9 days. The adverse events occurred within 6–8 days of treatment. For the 20 adverse events, 19 were not higher than grade 2 and only one was grade 3 because of the severely limited self-care ability in one patient. The most common adverse events were related to the digestive, circulatory, hepatic, and nervous systems.ConclusionOral chloroquine phosphate tablets resulted in a high incidence of adverse reactions. In the clinical trial of chloroquine phosphate for COVID-19 treatment, it should be used under pharmaceutical care; timely evaluation of the drug safety during the treatment process is necessary and a randomized controlled clinical trial should be conducted.

scholarly journals Does synbiotic supplementation affect the quality of life in children with cystic fibrosis? A pilot randomized controlled clinical trial

2020 ◽  
Author(s):  
Nemat Bilan ◽  
Effat Marefat ◽  
Leila Nikniaz ◽  
Mahdieh Abbasalizad Farhangi ◽  
Zeinab Nikniaz
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Cystic Fibrosis ◽  
Demographic Data ◽  
Intervention Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
The Mean ◽  
Synbiotic Supplementation

Abstract Background: There is no clinical trial that assesses the effect synbiotic supplementation on HRQOL in CF children. Considering the importance of HRQOL as an essential primary outcome and determinant of therapeutic benefit in chronic diseases like cystic fibrosis, the present clinical trial aimed to determine the efficacy of synbiotic supplementation on HRQOL in children with CF.Methods: In the present double-blind randomized clinical trial, 40 CF children were randomly allocated to the two groups. The intervention group was supplemented with synbiotics supplements and the patients in the placebo group received maltodextrin for six months. Demographic data and information about antibiotic use were recorded using the questionnaire. The health-related quality of life was assessed using the Persian version of quality of life inventory questionnaires. Paired t-test and ANCOVA were used for statistical analysis. Results: Totally, 36 participants completed the trial. The mean score of HRQOL was 76.34±17.33. There were no significant differences between synbiotic and placebo groups regarding baseline demographic and quality of life characteristics. Compared with baseline values, the mean total score and subscores of quality of life did not change significantly after synbiotic and placebo supplementation (p>0.05). Moreover, the results of ANCOVA showed that there were no significant differences between the two groups regarding the post-trial value of HRQOL total score and subscores. Conclusion: According to results, six-month supplementation with synbiotic did not have a significant effect on the HRQOL in children with CF. However, further studies with larger sample sizes and using more disease-specific questionnaires are needed for a more precise conclusion. The protocol of the study was registered at Iranian registry clinical trials (Registration code: IRCT2017011732004N1; Registration date: 2017-02-14).

scholarly journals Efficacy and Safety of Mulberry Twig Alkaloids Tablet for the Treatment of Type 2 Diabetes: A Multicenter, Randomized, Double-Blind, Double-Dummy, and Parallel Controlled Clinical Trial

2021 ◽  
Author(s):  
Ling Qu ◽  
Xiaochun Liang ◽  
Guoqing Tian ◽  
Gaili Zhang ◽  
Qunli Wu ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Clinical Trial ◽  
Adverse Events ◽  
Glycosylated Hemoglobin ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Significant Difference ◽  
Acarbose Treatment

<b>OBJECTIVE </b>This study aimed to evaluate the efficacy and safety of mulberry twig alkaloids (sangzhi alkaloids, SZ-A) in the treatment of type 2 diabetes (T2D).<a></a> <p><b>RESEARCH DESIGN AND METHODS</b><b> </b><a></a>This was a multicenter, randomized, double-blind, double-dummy, and parallel controlled non-inferiority clinical trial that was conducted for 24 weeks. A total of 600 patients were randomly allocated to the SZ-A group (<i>n</i>=360) or acarbose group (<i>n</i>=240). The primary efficacy endpoint was the change of glycosylated hemoglobin (HbA<sub>1c</sub>) in comparison to baseline. In addition, adverse events (AEs), severe adverse events (SAEs), <a>treatment-related </a><a>adverse events</a> (TAEs), and gastrointestinal disorders (GDs) were monitored.</p> <p><b>RESULTS</b> After treatment for 24 weeks, the change <a>in HbA1c was −0.93% (95% CI −1.03 to −0.83) (−10.2 mmol/mol, [95% CI −11.3 to −9.1]) and −0.87% (95% CI −0.99 to −0.76) (−9.5 mmol/mol, [95% CI −10.8 to −8.3]) in the SZ-A and acarbose groups, and the least squares mean difference was −0.05% (95% CI −0.18 to 0.07) (−0.5 mmol/mol, [95% CI −2.0 to 0.8]) between the two groups with no significant difference based on covariance analysis (P > 0.05). The incidence of TAEs and GDs was significantly lower in the SZ-A group than the acarbose group (P < 0.01), but no differences were found for AEs or SAEs between two groups were observed (P > 0.05).</a></p> <p><b>CONCLUSION</b> SZ-A exhibited equivalent hypoglycemic effect to acarbose in patients with T2D. Nevertheless, the incidence of TAEs and GDs was lower following SZ-A treatment than that following acarbose treatment, suggesting good safety.</p>

Efficacy of lettuce seed syrup on insomnia in patients with breast cancer: a pilot double blind randomized placebo controlled clinical trial

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Seyed Hamdollah Mosavat ◽  
Hamid Reza Mirzaei ◽  
Bahram Mofid ◽  
Reyhaneh Gharehgozlou ◽  
Mohammad Mahdi Parvizi ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Sleep Quality ◽  
Sleep Disorders ◽  
Controlled Clinical Trial ◽  
Lettuce Seed ◽  
Breast Cancer Patients ◽  
Double Blind ◽  
Before And After ◽  
The Mean

Abstract Objectives Insomnia and sleep disorders are common and can be severe amongst patients with cancer, especially during chemotherapy. The aim of this study was to evaluate the efficacy of lettuce seed syrup in breast cancer patients who suffer from insomnia or disordered sleep. Methods This pilot study was a double-blinded randomized controlled clinical trial conducted in Shoha-e-Tajrish Hospital (Tehran, Iran) from September 2018 to June 2019. 50 adult patients with breast cancer with insomnia or sleep disorders were enrolled. Participants were randomly allocated to lettuce seed syrup (5 mL twice daily), or placebo syrup at the same dose for four weeks. The Pittsburgh Sleep Quality Index (PSQI) was used to evaluate sleep quality before and after the intervention. Results Compared to placebo, the mean of the total PSQI score decreased significantly in participants who received lettuce seed syrup (p=0.014). In addition, there were statistically significant reductions in the mean scores of subject quality sleep (p=0.002), sleep duration (p=0.038), habitual sleep efficacy (p=0.029) and sleep disturbance (p=0.032) in patients who received lettuce seed syrup. Conclusions Lettuce seed syrup may improve self-reported sleep quality in participants with breast cancer. Larger trials are indicated in diverse samples of participants with caner to learn if these finds are generalizable.

Sign in / Sign up

Export Citation Format

Share Document