Clinical trial NCT00425633: Efficacy Study of Homeopathic Potassium Dichromate to Treat Tracheal Secretions in Critically Ill Patients
Official title: A Study To Evaluate The Effect Of Homeopathic Concentrations Of Potassium Dichromate On Tracheal Secretions In Critically Ill Patients.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Ventilator Adverse Event
Keywords: Homeopathic
Potassium
Dichromate
Kalium
Bichromicum
Mechanical
Ventilation
Secretions
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2007-01-23
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 (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.

Eligibility criteria: 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.

Primary outcomes:
measure: To evaluate the impact of potassium dichromate on the quantity of tracheal secretions.
timeFrame: until extubation
Secondary outcomes:
measure: 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.
timeFrame: until extubation
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Sharon Yamashita, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Frass M, Dielacher C, Linkesch M, Endler C, Muchitsch I, Schuster E, Kaye A. Influence of potassium dichromate on tracheal secretions in critically ill patients. Chest. 2005 Mar;127(3):936-41. doi: 10.1378/chest.127.3.936.