Effect of curcumin-pipeine supplementation on clinical status, mortality rate, oxidative stress, and inflammatory markers in critically ill ICU patients with COVID-19: a structured summary of a study protocol for a randomized controlled trial.
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ABSTRACT:
SUBMITTER: Askari G
PROVIDER: S-EPMC8258487 | biostudies-literature | 2021 Jul
REPOSITORIES: biostudies-literature
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Effect of curcumin-pipeine supplementation on clinical status, mortality rate, oxidative stress, and inflammatory markers in critically ill ICU patients with COVID-19: a structured summary of a study protocol for a randomized controlled trial.
Askari Gholamreza G Alikiaii Babak B Soleimani Davood D Sahebkar Amirhossein A Mirjalili Mahdiye M Feizi Awat A Iraj Bijan B Bagherniya Mohammad M
Trials 20210706 1
<h4>Objectives</h4>This study aims to investigate the efficacy of curcumin-piperine co-supplementation on oxidative stress factors, clinical symptoms, and mortality rate in patients with coronavirus (COVID-19) admitted to the intensive care unit (ICU).<h4>Trial design</h4>This study is a randomized, placebo-controlled, double-blind, parallel-arm clinical trial.<h4>Participants</h4>The study participants will be recruited from patients admitted to the ICU of Al-Zahra hospital with a definitive di ...[more]
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Project description:IntroductionOn February 25, 2020, the first 2 patients were tested positive for severe acute respiratory syndrome coronavirus‑2 (SARS-CoV-2) in Tyrol, Austria. Rapid measures were taken to ensure adequate intensive care unit (ICU) preparedness for a surge of critically ill coronavirus disease-2019 (COVID-19) patients.MethodsThis cohort study included all COVID-19 patients admitted to an ICU with confirmed or strongly suspected COVID-19 in the State of Tyrol, Austria. Patients were recorded in the Tyrolean COVID-19 intensive care registry. Date of final follow-up was July 17, 2020.ResultsA total of 106 critically ill patients with COVID-19 were admitted to 1 of 13 ICUs in Tyrol from March 9 to July 17, 2020. Median age was 64 years (interquartile range, IQR 54-74 years) and the majority of patients were male (76 patients, 71.7%). Median simplified acute physiology score III (SAPS III) was 56 points (IQR 49-64 points). The median duration from appearance of first symptoms to ICU admission was 8 days (IQR 5-11 days). Invasive mechanical ventilation was required in 72 patients (67.9%) and 6 patients (5.6%) required extracorporeal membrane oxygenation treatment. Renal replacement therapy was necessary in 21 patients (19.8%). Median ICU length of stay (LOS) was 18 days (IQR 5-31 days), median hospital LOS was 27 days (IQR 13-49 days). The ICU mortality was 21.7% (23 patients), hospital mortality was 22.6%. There was no significant difference in ICU mortality in patients receiving invasive mechanical ventilation and in those not receiving it (18.1% vs. 29.4%, p = 0.284). As of July 17th, 2020, two patients are still hospitalized, one in an ICU, one on a general ward.ConclusionCritically ill COVID-19 patients in Tyrol showed high severity of disease often requiring complex treatment with increased lengths of ICU and hospital stay. Nevertheless, the mortality was found to be remarkably low, which may be attributed to our adaptive surge response providing sufficient ICU resources.
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Project description:BackgroundPlatelets have been involved in both immune surveillance and host defense against severe infection. To date, whether platelet phenotype or other hemostasis components could be associated with predisposition to sepsis in critical illness remains unknown. The aim of this work was to identify platelet markers that could predict sepsis occurrence in critically ill injured patients.MethodsThis single-center, prospective, observational, 7-month study was based on a cohort of 99 non-infected adult patients admitted to ICUs for elective cardiac surgery, trauma, acute brain injury, and post-operative prolonged ventilation and followed up during ICU stay. Clinical characteristics and severity score (SOFA) were recorded on admission. Platelet activation markers, including fibrinogen binding to platelets, platelet membrane P-selectin expression, plasma soluble CD40L, and platelet-leukocytes aggregates were assayed by flow cytometry at admission and 48 h later, and then at the time of sepsis diagnosis (Sepsis-3 criteria) and 7 days later for sepsis patients. Hospitalization data and outcomes were also recorded.MethodsOf the 99 patients, 19 developed sepsis after a median time of 5 days. These patients had a higher SOFA score at admission; levels of fibrinogen binding to platelets (platelet-Fg) and of D-dimers were also significantly increased compared to the other patients. Levels 48 h after ICU admission no longer differed between the two patient groups. Platelet-Fg % was an independent predictor of sepsis (P = 0.0031). By ROC curve analysis, cutoff point for Platelet-Fg (AUC = 0.75) was 50%. In patients with a SOFA cutoff of 8, the risk of sepsis reached 87% when Platelet-Fg levels were above 50%. Patients with sepsis had longer ICU and hospital stays and higher death rate.ConclusionsPlatelet-bound fibrinogen levels assayed by flow cytometry within 24 h of ICU admission help identifying critically ill patients at risk of developing sepsis.
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Project description:ImportanceAltered heart rate variability has been associated with autonomic dysfunction in a number of disease profiles, in this work we elucidate differences in the biomarker among patients with all-cause sepsis and coronavirus disease 2019.ObjectivesTo measure heart rate variability metrics in critically ill coronavirus disease 2019 patients with comparison to all-cause critically ill sepsis patients.Design setting and participantsRetrospective analysis of coronavirus disease 2019 patients admitted to an ICU for at least 24 hours at any of Emory Healthcare ICUs between March 2020 and April 2020 up to 5 days of ICU stay. The comparison group was a cohort of all-cause sepsis patients prior to coronavirus disease 2019 pandemic.Main outcomes and measuresContinuous waveforms were captured from the patient monitor. The electrocardiogram was then analyzed for each patient over a 300 seconds observational window that was shifted by 30 seconds in each iteration from admission till discharge. A total of 23 heart rate variability metrics were extracted in each iteration. We use the Kruskal-Wallis and Steel-Dwass tests (p < 0.05) for statistical analysis and interpretations of heart rate variability multiple measures.ResultsA total of 141 critically ill coronavirus disease 2019 patients met inclusion criteria, who were compared with 208 patients with all-cause sepsis. Three nonlinear markers, including the ratio of standard deviation derived from the Poincaré plot, sample entropy, and approximate entropy and four linear features, including mode of beat-to-beat interval, acceleration capacity, deceleration capacity, and the proportion of consecutive RR intervals that differ by more than 50 ms, were all statistically significant (p < 0.05) between the coronavirus disease 2019 and all-cause sepsis cohorts. The three nonlinear features and acceleration capacity, deceleration capacity, and beat-to-beat interval (mode) were statistically significant (p < 0.05) when comparing pairwise analysis among the combinations of survivors and nonsurvivors between the coronavirus disease 2019 and sepsis cohorts. Temporal analysis of the main markers showed low variability across the 5 days of analysis compared with sepsis patients.Conclusions and relevanceIn this descriptive statistical study, heart rate variability measures were found to be statistically different across critically ill patients infected with severe acute respiratory syndrome coronavirus 2 and distinct from bacterial sepsis.
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Project description:BackgroundOxidative injury occurs in septic people, but the role of oxidative stress and antioxidants has rarely been evaluated in foals.Objectives/hypothesisTo measure reactive oxygen species (ROS), biomarkers of oxidative injury, and antioxidants in neonatal foals. We hypothesized that ill foals would have higher blood concentrations of ROS and biomarkers of oxidative injury and lower concentrations of antioxidants compared to healthy foals.AnimalsSeventy-two hospitalized and 21 healthy neonatal foals.MethodsProspective cohort study. Reactive oxygen species (hydrogen peroxide [H2O2]), biomarkers of oxidative injury (malondialdehyde [MDA], protein carbonyl), and antioxidants (superoxide dismutase [SOD], catalase [CAT], glutathione, and glutathione reductase [GR] and peroxidase [GPx]) were measured from foals at admission. Measured variables were compared between healthy and ill foals using a 1-way ANOVA by Tukey's multiple comparisons test.ResultsIll foals (n = 51) had significantly higher mean concentrations of H2O2 (healthy 2.6 ± 1.4 nmol/mL, ill 6.8 ± 4.6 L nmol/mL; 95% CI), MDA (healthy 31.2 ± 14.4 nmol/mL, ill 114.3 ± 94.0 nmol/mL; 95% CI), and protein carbonyl (healthy 0.07 ± 0.01 nmol/mg protein, ill 0.12 ± 0.02 nmol/mg protein, 95% CI). Significant lower CAT (healthy 0.4 ± 0.3 mU/mg protein, ill 0.02 ± 0.02 mU/mg protein, 95% CI), glutathione (healthy 238.5 ± 101.9 μg/mL, ill 110.7 ± 37.8 μg/mL, 95% CI; P < .0001), GR (healthy 1.6 ± 1.8 mU/mg protein, ill 0.4 ± 0.5 mU/mg protein, 95% CI), and GPx (healthy 0.01 ± 0.003 mU/mg protein, ill 0.007 ± 0.002 mU/mg protein, 95% CI) were also noted.Conclusions and clinical importanceOxidative stress and lower antioxidant concentrations occur in ill and bacteremic neonatal foals. These variables should be considered during the treatment of ill foals.
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Project description:ObjectivesThis study will evaluate the main hypothesis that supplementation with vitamins A, B, C, D, and E significantly improves the severity and mortality rate in ICU patients with COVID-19.Trial designThis study is a randomized, single-blinded, two-arm (1:1 ratio) parallel group clinical trial.ParticipantsWe are conducting this study in patients with COVID-19 admitted to intensive care units at the Imam Khomeini Hospital Complex in Tehran, Iran. The inclusion criteria are as follows: (1) aged between 20 and 60 years, (2) both male and female patients with COVID-19, (3) clinical or definitive diagnosis (using polymerase chain reaction (PCR) test), (4) patients have not participated in other clinical trials, and (5) no renal or hepatic abnormalities. The exclusion criteria are as follows: (1) patients with specific and rare viral diseases such as HIV and (2) patients who have been undergoing chemotherapy for the past month.Intervention and comparatorDuration of intervention: 7 days from randomization Intervention in the treatment group: Vitamin A 25,000 IU daily Vitamin D 600,000 IU once during study Vitamin E 300 IU twice daily Vitamin C is taken four times per day B vitamins are taken as a daily Soluvit [which included thiamine nitrate 3.1 mg, sodium riboflavin phosphate 4.9 mg (corresponding to vitamin B2 3.6 mg), nicotinamide 40 mg, pyridoxine hydrochloride 4.9 mg (corresponding to vitamin B6 4.0 mg), sodium pantothenate 16.5 mg (corresponding to pantothenic acid 15 mg), sodium ascorbate 113 mg (corresponding to vitamin C 100 mg), biotin 60 μg, folic acid 400 μg, and cyanocobalamin 5 μg] The control group will not receive any supplements or placebo. All supplements are made in Iran except for Soluvit (from Fresenius Kabi, New Zealand).Main outcomes1. Weight, height, and BMI 2. Severity of pulmonary involvement according to CT scan 3. Respiratory support (invasive or non-invasive) 4. Percentage of oxygen saturation (SpO2 level) 5. Serum levels of WBC, CRP, ESR, IL6, IFN-G, and TNF-α 6. The patient's body temperature 7. The presence or absence of involvement of organs other than the lungs (e.g., heart, liver, kidneys) 8. Duration of hospitalization 9. Mortality rate RANDOMIZATION: At baseline, eligible patients were randomly assigned to a 1:1 ratio to one of two groups: intervention and control. Block randomization is used based on the gender of patients.Blinding (masking)Patients are unaware of being placed in the intervention or control groups after signing consent. All treatment staff will be aware of which group each of the patients is in due to the specific conditions of the ICU and the absence of placebo for the control group.Numbers to be randomized (sample size)The researchers plan to include 60 patients in total, with 30 patients in each group.Trial statusThis is the first version of the protocol which started on April 2, 2020. Recruitment began April 2, 2020, and is expected to be complete by July 4, 2020.Trial registrationThe Iranian Registry of Clinical Trials IRCT20200319046819N1 . Registered on April 4, 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol (Fig. 1, Table 1).
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Project description:We report preliminary data from a cohort of adults admitted to COVID-designated intensive care units from March 6 through April 17, 2020 across an academic healthcare system. Among 217 critically ill patients, mortality for those who required mechanical ventilation was 29.7% (49/165), with 8.5% (14/165) of patients still on the ventilator at the time of this report. Overall mortality to date in this critically ill cohort is 25.8% (56/217), and 40.1% (87/217) patients have survived to hospital discharge. Despite multiple reports of mortality rates exceeding 50% among critically ill adults with COVID-19, particularly among those requiring mechanical ventilation, our early experience indicates that many patients survive their critical illness.
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Project description:Critically ill polytrauma patients have increased production of free radicals (FRs) and consequent alterations in biochemical pathways, as well as disruption of cellular integrity, due to increased lipid peroxidation. The aim of this study was to investigate several biomarkers associated with increased oxidative stress in critically ill polytrauma patients, and to evaluate the effect of antioxidant treatment on the clinical outcome in these patients. A total of 67 polytrauma patients from an intensive care unit met the selection criteria. Antiox group included 35/67 patients who received antioxidant therapy, while 32/67 patients without antioxidant treatment were considered as control group. Antioxidant therapy consisted of simultaneous administration of Vitamin C (sodium ascorbate) and N-acetylcysteine, through continuous intravenous infusion. Clinical and paraclinical evaluation of the patients was performed daily until discharge or death. At admission, laboratory parameters did not differ significantly between two groups. At discharge/upon death, statistically significant differences in favor of Antiox group were observed in the following parameters: thrombocytes, activated partial thromboplastin time, prothrombin time, total bilirubin, total cholesterol, high-density lipoproteins, low-density lipoproteins, erythrocyte sedimentation rate, interleukin 6 (all p = 0.0001), total protein (p = 0.0005), serum albumin (p = 0.0004), lactate dehydrogenase (p = 0.0006), and C-reactive protein (p = 0.0014). Starting from day 5, the APACHE II score was significantly decreased in Antiox versus control group (p < 0.05). Finally, the sepsis incidence and mortality rate were significantly lower in Antiox group (p < 0.05). Decreasing the level of oxidative stress by antioxidant substances significantly correlated with a better prognosis and outcome in our patients. Further studies should elucidate more clearly the mechanism of action of antioxidants in critically ill polytrauma patients.
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Project description: Not available
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Project description:ObjectivesPrimary objective: To estimate the effect of corticosteroids compared with usual care or placebo on mortality up to 28 days after randomization. Secondary objectives: To examine whether the effect of corticosteroids compared with usual care or placebo on mortality up to 28 days after randomization varies between subgroups related to treatment characteristics, disease severity at the time of randomization, patient characteristics, or risk of bias. To examine the effect of corticosteroids compared with usual care or placebo on serious adverse events.Study designProspective meta-analysis of randomized controlled trials. Both placebo-controlled and open-label trials are eligible.ParticipantsHospitalised, critically ill patients with suspected or confirmed COVID-19.Intervention and comparatorIntervention groups will have received therapeutic doses of a steroid (dexamethasone, hydrocortisone or methylprednisolone) with IV or oral administration immediately after randomization. The comparator groups will have received standard of care or usual care or placebo.Main outcomeAll-cause mortality up to 28 days after randomization.Search methodsSystematic searching of clinicaltrials.gov , EudraCT, the WHO ISRCTN registry, and the Chinese clinical trials registry. Additionally, research and WHO networks will be asked for relevant trials.Risk of bias assessmentsThese will be based on the Cochrane RoB 2 tool, and will use structured information provided by the trial investigators on a form designed for this prospective meta-analysis. We will use GRADE to assess the certainty of the evidence.Statistical analysesTrial investigators will provide data on the numbers of participants who did and did not experience each outcome according to intervention group, overall and in specified subgroups. We will conduct fixed-effect (primary analysis) and random-effects (Paule-Mandel estimate of heterogeneity and Hartung-Knapp adjustment) meta-analyses. We will quantify inconsistency in effects between trials using I2 statistics. Evidence for subgroup effects will be quantified by ratios of odds ratios comparing effects in the subgroups, and corresponding interaction p-values. Comparisons between subgroups defined by trial characteristics will be made using random-effects meta-regression. Comparisons between subgroups defined by patient characteristics will be made by estimating trial-specific ratios of odds ratios comparing intervention effects between subgroups then combining these using random-effects meta-analysis. Steroid interventions will be classified as high or low dose according to whether the dose is greater or less than or equal to 400 mg hydrocortisone per day or equivalent. We will use network meta-analysis methods to make comparisons between the effects of high and low dose steroid interventions (because one trial randomized participants to both low and high dose steroid arms).Prospero registration numberCRD42020197242 FULL PROTOCOL: The full protocol for this prospective meta-analysis is attached as an additional file, accessible from the Trials website (Additional file 1). To expedite dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol for the systematic review.
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