Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00425633
Status:
TERMINATED
Last Update Posted:
2011-03-25
First Post:
2007-01-22
Brief Title:
Efficacy Study of Homeopathic Potassium Dichromate to Treat Tracheal Secretions in Critically Ill Patients
Sponsor:
Sunnybrook Health Sciences Centre
Organization:
Sunnybrook Health Sciences Centre
Study Overview
Official Title:
A Study To Evaluate The Effect Of Homeopathic Concentrations Of Potassium Dichromate On Tracheal Secretions In Critically Ill Patients
Status:
TERMINATED
Status Verified Date:
2011-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to find out whether homeopathic potassium dichromate will decrease the time on the breathing machine and the amount of phlegm that you produce in your lungs In addition this study will look at whether participants spend less time in a critical care unit and if the chances of being placed back on a breathing machine can be lessened
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 p00001 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 Bichromicumvs 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
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 p00001 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 Bichromicumvs 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None