- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00425633
Efficacy Study of Homeopathic Potassium Dichromate to Treat Tracheal Secretions in Critically Ill Patients
A Study To Evaluate The Effect Of Homeopathic Concentrations Of Potassium Dichromate On Tracheal Secretions In Critically Ill Patients.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Prolonged mechanical ventilation is associated with greater mortality, increased need for tracheostomy, prolonged length of critical care stay and higher costs. Risk factors identifying patients at greater risk of unsuccessful extubation include cough strength, endotracheal secretions and neurological status. These factors are synergistic and patients exhibiting two of the above determinants have an extubation failure rate of 81%. The risk is 100% if all three are present as compared to 3% in a patient with no risk factors. Several strategies including administration of mucolytics, anti-cholinergics and corticosteroids have met with limited success or excessive toxicity. Thus, methods to improve the quality and quantity of secretions could be associated with decreased extubation failure and greater overall outcomes.
The most recent study was a randomized, double blind, placebo controlled trial of 50 critically ill ventilated patients with a previous history of COPD and tobacco use by Frass et al. Five C30 pellets of potassium dichromate or placebo were administered twice daily until extubation and it was found that those receiving the homeopathic formulation had statistically significant (p<0.0001) tracheal secretion reductions, earlier extubation times and shorter lengths of stay in critical care as compared to their placebo counterparts.
Use of homeopathy in the critically ill would convey a number of advantages including lack of adverse effects or drug interactions, due to the dilute nature of the solutions, and be a cost effective adjunct to conventional therapy. In the previous trial of potassium dichromate in critical care patients, only patients with previous tobacco use and history of COPD were included. It is unknown whether those results could be extrapolated to the general critical care population.
Therefore, this study will look at the safety and efficacy of homeopathic potassium dichromate (Kalium Bichromicum)vs placebo. A dosing schedule of five pellets every 12 hours will be utilized; this regimen was chosen based on previous evidence showing efficacy at this dose. Dosing will continue until the patient is extubated or chooses to withdraw from the study. Data collected will include baseline demographic data, quantity of sputum production (at baseline and per day), number of times suctioning required per day, duration of mechanical ventilation, rate of reintubation within 7 days following extubation, critical care length of stay, PaO2/ FiO2 ratios, PaCO2 twice daily, and number of therapeutic bronchoscopies.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Sciences Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients 18yrs and older
- Situated in the Critical Care areas of Sunnybrook Health Sciences Centre including the Critical Care Unit, Cardiovascular Surgery Intensive Care Unit, Ross Tilley Burn Centre and B5/D4 intensive care units.
- They will have been weaned from mechanical ventilation (eg: extubated, face mask or tracheostomy mask, minimal pressure support or CPAP, FiO2 <0.3) but are unable to be transferred out of the unit due to excessive and/or persistent secretions for at least 48 hours.
- Persistent secretions will be defined as suctioning of greater than every 2 hours or a score of greater than 20-24 "MP" per day. (In the Critical Care areas, each time a patient is suctioned, secretions are quantified on a scale of 1-3, with "MP" being mucopurulent in nature).
Exclusion Criteria:
- Those with evidence of untreated respiratory infections or infections treated for less than 48 hours.
- Those patients on high dose steroids as defined by greater than:Fluticasone 125ug inhaler- four puffs twice daily and/or Prednisone 20mg daily orally
- Patients with multiple drug and/or environmental allergies
- Those patients who fail to give informed written consent.
- Those patients currently enrolled in another clinical trial or who have been approached for participation in a trial during the last 30 days.
- Previous enrollment in this study
- Pregnancy- all women of child bearing age will be administered a pregnancy test before inclusion into the study to verify their status.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate the impact of potassium dichromate on the quantity of tracheal secretions.
Time Frame: until extubation
|
until extubation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate the efficacy of homeopathic potassium dichromate on duration of mechanical ventilation, required suctioning per day, re-intubation rate, length of ICU admission and number of therapeutic bronchoscopies required.
Time Frame: until extubation
|
until extubation
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sharon Yamashita, PharmD, Sunnybrook Health Sciences Centre
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 418-2006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ventilator Adverse Event
-
Xuanwu Hospital, BeijingUnknown
-
Nantes University HospitalUniversité de NantesNot yet recruiting
-
Université du Québec à Trois-RivièresCompleted
-
University of Colorado, DenverCompletedVentilator Adverse Event | Infant Showing No Response to Resuscitation | Apparent Life Threatening Event in Newborn and InfantUnited States, Ireland
-
Hospices Civils de LyonUnknown
-
Universidad Miguel Hernandez de ElcheFundación para el Fomento de la Investigación Sanitaria y Biomédica de la...Active, not recruiting
-
Lucie HeinzerlingRecruitingImmune-related Adverse EventGermany
-
Kocaeli UniversityCompletedVentilator-Induced Lung Injury | Ventilator Adverse Event | Lung Injury, AcuteTurkey
-
Chang Gung Memorial HospitalMinistry of Science and Technology, TaiwanRecruitingImmune-related Adverse EventTaiwan
-
University of RochesterAgency for Healthcare Research and Quality (AHRQ)CompletedAdverse Drug Event, Potential Adverse Drug Event, and Quality MeasuresUnited States
Clinical Trials on Homeopathic Potassium Dichromate
-
Shaare Zedek Medical CenterHadassah Medical OrganizationUnknown
-
Michael FrassSigmund Freud PrivatUniversitatCompletedAdjustment Reaction With Physical SymptomsAustria
-
Medical University of ViennaCompleted
-
Charite University, Berlin, GermanyTerminatedMajor DepressionGermany
-
University of TorontoCentre for Addiction and Mental Health; Lotte & John Hecht Memorial FoundationActive, not recruitingAttention Deficit Hyperactivity DisorderCanada
-
Integrative Medicine InstituteSouthwest College of Naturopathic Medicine; Heel GmbHWithdrawn
-
Medical University of ViennaCompleted
-
Hadassah Medical OrganizationCompletedChildren's Dental AnxietyIsrael
-
University of JohannesburgCompletedInsomnia DisorderSouth Africa
-
Michael FrassCompleted