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 Evaluation the preventive effect of Selenium on acute kidney injury following on-pump cardiac surgery

2021 ◽  
Keyword(s):  
Acute Kidney Injury ◽  
Cardiac Surgery ◽  
Stress Responses ◽  
Kidney Injury ◽  
Control Group ◽  
Double Blind ◽  
Hospitalization Period ◽  
Significant Difference ◽  
Postoperative Stress ◽  
And Control

Introduction: patients who undergo on-pump cardiac surgery are at risk of acute kidney injury following the operation. This is mainly due to some ischemic events and also pre- and postoperative stress responses which can result in postoperative organ dysfunction. Selenium as an antioxidant may help to reduce the inflammation and subsequent related complications. In this study we tested that if administration of oral Se compliment before and following the on-pump cardiac surgery can reduce the incidence or severity of kidney injury following the operation. Methods: In a randomized double-blind trial we divided the randomly selected patients who were candidate for on-pupm cardiac surgery into two groups of those who received selenium and control group. In selenium group we administrated 500 µg of selenium orally 14 and 2 hours before surgery and every 12 hours postoperatively for 2 days (overall 3000 µg) while the control group received only the routine and standard care. Subsequently patients were closely observed for serum creatinine rise and incidence of post-operative AKI during their hospitalization period in both groups using both Rifle and AKIN criteria separately. Besides, some additional data including: ICU-stay, duration of the operation and need for Blood products during the operation were recorded. At the end, the statistical analysis was carried out using SPSS 11.5 software in order to determine any significant difference in case and control group. Results: The study population included 120 patients divided in two equal groups of 60, consisting of 46 (38.3%) males and 74 (61.7%) females with the mean age of 52.8±16.7 years. Both groups were similar regarding the demographics and comorbidities. Also statistics showed no significant difference regarding Cardiac Operative Risk Evaluation (EuroSCORE) in both groups. Considering the RIFLR criteria, AKI occurred in 11 (17.9%) patients in selenium group and 13 (21.4%) patients in control group while based on AKIN criteria figures were 17 (28.6%) and 21 (35.7%) in selenium and the control group , respectively. The most frequent stage of AKI among patients was the first stage in both group and the highest rate of AKI occurred in 3-4 days after surgery in both groups. Conclusion: According to our research Administrating oral Selenium was not beneficial in order to prevent AKI after on-pump cardiac surgery.

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 Erythropoietin in Acute Kidney Injury (EAKI): a Pragmatic Randomized Clinical Trial

2022 ◽  
Author(s):  
Mabel Aoun ◽  
Ghassan Sleilaty ◽  
Celine Boueri ◽  
Eliane Younes ◽  
Kim Gabriel ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Acute Kidney Injury ◽  
Kidney Injury ◽  
Standard Of Care ◽  
Renal Recovery ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Human Erythropoietin ◽  
Significant Difference ◽  
Erythropoietin Treatment

Abstract Background Treatment with erythropoietin is well established for anemia in chronic kidney disease patients but not well studied in acute kidney injury.MethodsThis is a multicenter, randomized, pragmatic controlled clinical trial. It included 134 hospitalized patients with anemia defined as hemoglobin <11 g/dL and acute kidney injury defined as an increase of serum creatinine of 0.3 mg/dL within 48 hours or 1.5 times baseline. One arm received recombinant human erythropoietin 4000 UI subcutaneously every other day (intervention; n=67) and the second received standard of care (control; n=67) during the hospitalization until discharge or death. The primary outcome was the need for transfusion; secondary outcomes were death, renal recovery, need for dialysis.ResultsThere was no statistically significant difference in transfusion need (RR=1.05, 95%CI 0.65,1.68; p=0.855), in renal recovery full or partial (RR=0.96, 95%CI 0.81,1.15; p=0.671), in need for dialysis (RR=11.00, 95%CI 0.62, 195.08; p=0.102) or in death (RR=1.43, 95%CI 0.58,3.53; p=0.440) between the erythropoietin and the control group. ConclusionsErythropoietin treatment had no impact on transfusions, renal recovery or mortality in acute kidney injury patients with anemia. The trial was registered on ClinicalTrials.gov (NCT03401710, 17/01/2018).

scholarly journals Single High-Dose Vitamin D Supplementation as an Approach for Reducing Ultramarathon-Induced Inflammation: A Double-Blind Randomized Controlled Trial

Nutrients ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 1280
Author(s):  
Jan Mieszkowski ◽  
Andżelika Borkowska ◽  
Błażej Stankiewicz ◽  
Andrzej Kochanowicz ◽  
Bartłomiej Niespodziński ◽  
...  
Keyword(s):  
Vitamin D ◽  
Inflammatory Marker ◽  
Controlled Trial ◽  
Vitamin D Supplementation ◽  
Oncostatin M ◽  
Control Group ◽  
High Dose ◽  
Double Blind ◽  
Single High Dose ◽  
High Dose Vitamin

Purpose: A growing number of studies indicate the importance of vitamin D supplementation for sports performance. However, the effects of a single high-dose vitamin D supplementation on ultramarathon-induced inflammation have not been investigated. We here analyzed the effect of a single high-dose vitamin D supplementation on the inflammatory marker levels in ultramarathon runners after an ultramarathon run (maximal run 240 km). Methods: In the study, 35 runners (amateurs) were assigned into two groups: single high-dose vitamin D supplementation group, administered vitamin D (150,000 IU) in vegetable oil 24 h before the start of the run (n = 16); and placebo group (n = 19). Blood was collected for analysis 24 h before, immediately after, and 24 h after the run. Results: Serum 25(OH)D levels were significantly increased after the ultramarathon in both groups. The increase was greater in the vitamin D group than in the control group. Based on post-hoc and other analyses, the increase in interleukin 6 and 10, and resistin levels immediately after the run was significantly higher in runners in the control group than that in those in the supplementation group. Leptin, oncostatin M, and metalloproteinase tissue inhibitor levels were significantly decreased in both groups after the run, regardless of the supplementation. Conclusions: Ultramarathon significantly increases the serum 25(OH)D levels. Attenuation of changes in interleukin levels upon vitamin D supplementation confirmed that vitamin D has anti-inflammatory effect on exercise-induced inflammation.

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