Efficacy Study of Homeopathic Potassium Dichromate to Treat Tracheal Secretions in Critically Ill Patients
|Ventilator Adverse Event||Drug: Homeopathic Potassium Dichromate||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||A Study To Evaluate The Effect Of Homeopathic Concentrations Of Potassium Dichromate On Tracheal Secretions In Critically Ill Patients.|
- To evaluate the impact of potassium dichromate on the quantity of tracheal secretions. [ Time Frame: until extubation ]
- 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 ]
|Study Start Date:||January 2007|
|Study Completion Date:||January 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Drug: Homeopathic Potassium Dichromate
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00425633
|Sunnybrook Health Sciences Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|Principal Investigator:||Sharon Yamashita, PharmD||Sunnybrook Health Sciences Centre|