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TerminatedNCT00425633Updated Mar 25, 2011

Efficacy Study of Homeopathic Potassium Dichromate to Treat Tracheal Secretions in Critically Ill Patients

A Phase 2 interventional study of Homeopathic Potassium Dichromate in Ventilator Adverse Event, sponsored by Sunnybrook Health Sciences Centre. Terminated at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-03-25.

Sponsored by Sunnybrook Health Sciences Centre · Phase 2, Interventional, and Treatment

Why this study was terminated
slow recruitment
Phase
Phase 2
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Ventilator Adverse Event

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Keywords

  • Homeopathic
  • Potassium
  • Dichromate
  • Kalium
  • Bichromicum
  • Mechanical
  • Ventilation
  • Secretions
03

In context

Critical Illness

1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.

This study's enrollment of 16 is below the median of 90 across 979 interventional studies indexed under Critical Illness.

Browse Critical Illness studies →

Lead sponsor

Sunnybrook Health Sciences Centre is the lead sponsor of 566 studies on the registry; 134 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
16 participants (actual)

Interventions

  • DrugHomeopathic Potassium Dichromate

    5 pellets under tongue q12h until extubation

06

What researchers measure

Primary outcomes

  1. To evaluate the impact of potassium dichromate on the quantity of tracheal secretions.

    Time frame: until extubation

Secondary outcomes

  1. 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

07

Study locations

1 site
  • Sunnybrook Health Sciences Centre
    Toronto, Ontario M4N 3M5, Canada
08

References and documents

Publications

  • 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. PubMed 15764779 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00425633
Lead sponsor
Sunnybrook Health Sciences Centre
First posted
Jan 23, 2007
Start date
Jan 2007
Primary completion
Jan 2010
Completion
Jan 2010
Last update
Mar 25, 2011

Study contacts

Sharon Yamashita, PharmD
principal investigator · Sunnybrook Health Sciences Centre

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.

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