Adjunctive homeopathic treatment in patients with severe sepsis: a randomized, double-blind, placebo-controlled trial in an intensive care unit

Homeopathy ◽  
2005 ◽  
Vol 94 (2) ◽  
pp. 75-80 ◽  
Author(s):  
M Frass ◽  
M Linkesch ◽  
S Banyai ◽  
G Resch ◽  
C Dielacher ◽  
...  
Keyword(s):  
Intensive Care Unit ◽  
Severe Sepsis ◽  
Intensive Care ◽  
Controlled Trial ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Homeopathic Treatment

scholarly journals Prospective Randomized Double-Blind Placebo Controlled Trial of Recombinant Human Erythropoietin Administration to Reduce Blood Transfusions in Anemic Pediatric Intensive Care Patients

2006 ◽  
Vol 11 (2) ◽  
pp. 101-106 ◽  
Author(s):  
Michael F. Chicella ◽  
Kem P. Krueger
Keyword(s):  
Intensive Care Unit ◽  
Intensive Care ◽  
Pediatric Intensive Care Unit ◽  
Recombinant Human Erythropoietin ◽  
Reticulocyte Count ◽  
Controlled Trial ◽  
Pediatric Intensive Care ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Human Erythropoietin

OBJECTIVE The purpose of this study was to determine if the number of red blood cell (RBC) transfusions anemic pediatric intensive care unit patients receive could be reduced by the prophylactic administration of recombinant human erythropoietin (rHuEPO). METHODS This was a randomized, double-blind placebo controlled trial. Patients were randomized to receive either intravenous rHuEPO 300 units/kg/day or placebo. Both groups received elemental iron 6 mg/kg/day. RESULTS Twenty-seven patients, ages 1 month to 13 years, were enrolled. Baseline hematocrit (Hct), reticulocyte count, and erythropoietin concentration were similar between the two groups. Three patients randomized to rHuEPO received 1 RBC transfusion each, and 4 patients randomized to placebo received 9 transfusions total (P = .68). The end-of-study Hct was not significantly different between the rHuEPO and placebo groups, 30.3 ± 3.6 and 26.8 ± 4.8, respectively (P = .06). Additionally, neither the % Hct change (baseline to final), nor the % reticulocyte change (baseline to final), was statistically different between the two groups. CONCLUSION In this small group of anemic pediatric intensive care unit patients, prophylactic rHuEPO administration did not reduce the number of patients who received RBC transfusions. Furthermore, it did not significantly increase Hct or reticulocyte count when compared to placebo.

scholarly journals Efficacy and safety of dexmedetomidine for prevention of withdrawal syndrome in the pediatric intensive care unit: protocol for an adaptive, multicenter, randomized, double-blind, placebo-controlled, non-profit clinical trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Maria Cristina Mondardini ◽  
Francesca Sperotto ◽  
Marco Daverio ◽  
Fabio Caramelli ◽  
Dario Gregori ◽  
...  
Keyword(s):  
Intensive Care Unit ◽  
Intensive Care ◽  
Pediatric Intensive Care Unit ◽  
Withdrawal Syndrome ◽  
Clinical Signs ◽  
Pediatric Intensive Care ◽  
University Hospital ◽  
Prolonged Treatment ◽  
Double Blind ◽  
Double Blind Placebo

Abstract Background Prolonged treatment with analgesic and sedative drugs in the pediatric intensive care unit (PICU) may lead to undesirable effects such as dependence and tolerance. Moreover, during analgosedation weaning, patients may develop clinical signs of withdrawal, known as withdrawal syndrome (WS). Some studies indicate that dexmedetomidine, a selective α2-adrenoceptor agonist, may be useful to prevent WS, but no clear evidence supports these data. The aims of the present study are to evaluate the efficacy of dexmedetomidine in reducing the occurrence of WS during analgosedation weaning, and to clearly assess its safety. Methods We will perform an adaptive, multicenter, randomized, double-blind, placebo-controlled trial. Patients aged < 18 years receiving continuous intravenous analgosedation treatment for at least 5 days and presenting with clinical conditions that allow analgosedation weaning will be randomly assigned to treatment A (dexmedetomidine) or treatment B (placebo). The treatment will be started 24 h before the analgosedation weaning at 0.4 μg/kg/h, increased by 0.2 μg/kg/h per hour up to 0.8 μg/kg/h (neonate: 0.2 μg/kg/h, increased by 0.1 μg/kg/h per hour up to 0.4 μg/kg/h) and continued throughout the whole weaning time. The primary endpoint is the efficacy of the treatment, defined by the reduction in the WS rate among patients treated with dexmedetomidine compared with patients treated with placebo. Safety will be assessed by collecting any potentially related adverse event. The sample size assuring a power of 90% is 77 patients for each group (total N = 154 patients). The study was approved by the Ethics Committee of the University-Hospital S.Orsola-Malpighi of Bologna on 22 March 2017. Discussion The present trial will allow us to clearly assess the efficacy of dexmedetomidine in reducing the occurrence of WS during weaning from analgosedation drugs. In addition, the study will provide a unique insight into the safety profile of dexmedetomidine. Trial registration ClinicalTrials.gov, NCT03645603. Registered on 24 August 2018. EudraCT, 2015–002114-80. Retrospectively registered on 2 January 2019.

scholarly journals Efficacy and safety of Dexmedetomidine for prevention of withdrawal syndrome in Pediatric Intensive Care Unit: protocol for an adaptive, multicenter, randomized, double blind, placebo-controlled, non-profit clinical trial

2019 ◽  
Author(s):  
Maria Cristina Mondardini ◽  
Francesca Sperotto ◽  
Marco Daverio ◽  
Fabio Caramelli ◽  
Dario Gregori ◽  
...  
Keyword(s):  
Intensive Care Unit ◽  
Intensive Care ◽  
Pediatric Intensive Care Unit ◽  
Withdrawal Syndrome ◽  
Clinical Signs ◽  
Pediatric Intensive Care ◽  
University Hospital ◽  
Prolonged Treatment ◽  
Double Blind ◽  
Double Blind Placebo

Abstract Background: Prolonged treatment with analgesic and sedative drugs in Pediatric Intensive Care Unit (PICU) may lead to undesirable effects as dependence and tolerance. Moreover, during the analgosedation weaning patients may develop clinical signs of withdrawal, known as withdrawal syndrome (WS). Some studies indicated that dexmedetomidine, a selective α2-adrenoceptors agonist, may be useful to prevent WS, but no clear evidences support this data. Aims of the present study are to evaluate the efficacy of dexmedetomidine in reducing the occurrence of WS during the analgosedation weaning, and to clearly assess its safety. Methods: We will perform an adaptive, multicenter, randomized, double-blind, placebo-controlled trial. Patients <18 years receiving a continuous intravenous analgosedation treatment for at least 5 days and presenting with clinical conditions that allows the analgosedation weaning will be randomly assigned to treatment A (dexmedetomidine) or treatment B (placebo). The treatment will be started 24 hours before the analgosedation-weaning at 0.4 mcg/kg/h, increased of 0.2 mcg/kg/h per hour up to 0.8 mcg/Kg/h (neonate: 0.2 mcg/Kg/h, increased of 0.1 mcg/Kg/h per hour up to 0.4 mcg/Kg/h)and continued throughout the whole weaning-time. The primary endpoint is the efficacy of the treatment, defined by the reduction in WS rate among patients treated with dexmedetomidine comparing with patients treated with placebo. Safety will be assessed collecting any potentially-related adverse event. The sample size assuring a power of 90% is 77 patients for each group (N total=154 patients). The study was approved by the Ethics Committee of the University-Hospital S.Orsola-Malpighi of Bologna on 22 March 2017. Discussion: The present trial will allow to clearly assess the efficacy of dexmedetomidine in reducing the occurrence of WS during the weaning of analgosedation drugs. In addition, the study will provide a unique insight into the safety profile of dexmedetomidine. Trial registration: AIFA ID TIP-15-01.ClinicalTrials.govID NCT03645603, registered on 24 August 2018. Retrospectively registered on EudraCT with ID 2015-002114-80 on 2 Jan 2019.

scholarly journals Efficacy of halopeRIdol to decrease the burden of Delirium In adult Critically ill patiEnts (EuRIDICE): study protocol for a prospective randomised multi-centre double-blind placebo-controlled clinical trial in the Netherlands

BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e036735
Author(s):  
Lisa Smit ◽  
Zoran Trogrlić ◽  
John W Devlin ◽  
Robert-Jan Osse ◽  
Huibert H Ponssen ◽  
...  
Keyword(s):  
Intensive Care ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Controlled Trial ◽  
Neurological Injury ◽  
Study Endpoint ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Icu Discharge

IntroductionDelirium in critically ill adults is associated with prolonged hospital stay, increased mortality and greater cognitive and functional decline. Current practice guideline recommendations advocate the use of non-pharmacological strategies to reduce delirium. The routine use of scheduled haloperidol to treat delirium is not recommended given a lack of evidence regarding its ability to resolve delirium nor improve relevant short-term and longer-term outcomes. This study aims to evaluate the efficacy and safety of haloperidol for the treatment of delirium in adult critically ill patients to reduce days spent with coma or delirium.Methods and analysisEuRIDICE is a prospective, multi-centre, randomised, double-blind, placebo-controlled trial. Study population consists of adult intensive care unit (ICU) patients without acute neurological injury who have delirium based on a positive Intensive Care Delirium Screening Checklist (ICDSC) or Confusion Assessment Method for the ICU (CAM-ICU) assessment. Intervention is intravenous haloperidol 2.5 mg (or matching placebo) every 8 hours, titrated daily based on ICDSC or CAM-ICU positivity to a maximum of 5 mg every 8 hours, until delirium resolution or ICU discharge. Main study endpoint is delirium and coma-free days (DCFD) up to 14 days after randomisation. Secondary endpoints include (1) 28-day and 1-year mortality, (2) cognitive and functional performance at 3 and 12 months, (3) patient and family delirium and ICU experience, (4) psychological sequelae during and after ICU stay, (4) safety concerns associated with haloperidol use and (5) cost-effectiveness. Differences in DCFDs between haloperidol and placebo group will be analysed using Poisson regression analysis. Study recruitment started in February 2018 and continues.Ethics and disseminationThe study has been approved by the Medical Ethics Committee of the Erasmus University Medical Centre Rotterdam (MEC2017-511) and by the Institutional Review Boards of the participating sites. Its results will be disseminated via peer-reviewed publication and conference presentations.Trial registrationNCT03628391

scholarly journals Study protocol for a randomised controlled trial evaluating the effects of the orexin receptor antagonist suvorexant on sleep architecture and delirium in the intensive care unit

BMJ Open ◽  
2020 ◽  
Vol 10 (7) ◽  
pp. e038474
Author(s):  
Omid Azimaraghi ◽  
Maximilian Hammer ◽  
Peter Santer ◽  
Katharina Platzbecker ◽  
Friederike C Althoff ◽  
...  
Keyword(s):  
Intensive Care Unit ◽  
Intensive Care ◽  
Receptor Antagonist ◽  
Medical Center ◽  
Controlled Trial ◽  
Sleep Onset ◽  
Secondary Outcome ◽  
Night Time ◽  
Subjective Sleep Quality ◽  
Double Blind

IntroductionInsomnia frequently occurs in patients admitted to an intensive care unit (ICU). Sleep-promoting agents may reduce rapid eye movement sleep and have deliriogenic effects. Suvorexant (Belsomra) is an orexin receptor antagonist with Food and Drug Administration (FDA) approval for the treatment of adult insomnia, which improves sleep onset and maintenance as well as subjective measures of quality of sleep. This trial will evaluate the efficacy of postoperative oral suvorexant treatment on night-time wakefulness after persistent sleep onset as well as the incidence and duration of delirium among adult cardiac surgical patients.Methods and analysisIn this single-centre, randomised, double-blind, placebo-controlled trial, we will enrol 120 patients, aged 60 years or older, undergoing elective cardiac surgery with planned postoperative admission to the ICU. Participants will be randomised to receive oral suvorexant (20 mg) or placebo one time a day starting the night after extubation. The primary outcome will be wakefulness after persistent sleep onset. The secondary outcome will be total sleep time. Exploratory outcomes will include time to sleep onset, incidence of postoperative in-hospital delirium, number of delirium-free days and subjective sleep quality.Ethics and disseminationEthics approval was obtained through the ‘Committee on Clinical Investigations’ at Beth Israel Deaconess Medical Center (protocol number 2019P000759). The findings will be published in peer-reviewed journals.Trial registration numberThis trial has been registered at clinicaltrials.gov on 17 September 2019 (NCT04092894).

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