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

NCT00425633 | Terminated Phase 2

• 1 other identifier: 418-2006
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilator Adverse Event

Keywords

Homeopathic; Potassium; Dichromate; Kalium; Bichromicum; Mechanical; Ventilation; Secretions

Outcome Measures

Primary Outcomes (1)

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

  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.

  until extubation

Interventions

Homeopathic Potassium Dichromate DRUG

5 pellets under tongue q12h until extubation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (1)

• 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.

  PMID: 15764779 BACKGROUND

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sharon Yamashita, PharmD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 22, 2007
• First Posted: January 23, 2007
• Study Start: January 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: March 25, 2011

Record last verified: 2011-03

Locations

CA (1)