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Effect of the Homeopathic Remedy Kalium Bichromicum (Potassium Dichromate) on Viscosity and Amount of Sputum and Time to Extubation in Mechanically Ventilated ICU Patients.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Shaare Zedek Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Hadassah Medical Organization
Information provided by (Responsible Party):
Menachem Oberbaum, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT00473473
First received: May 14, 2007
Last updated: February 19, 2012
Last verified: February 2012

May 14, 2007
February 19, 2012
July 2008
December 2012   (final data collection date for primary outcome measure)
the amount of tracheal secretions in patients intubated with a conventional endotracheal tube and receiving controlled mechanical ventilation with a respirator two days after the initiation of the study. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
the amount of tracheal secretions in patients intubated with a conventional endotracheal tube and receiving controlled mechanical ventilation with a respirator two days after the initiation of the study.
Complete list of historical versions of study NCT00473473 on ClinicalTrials.gov Archive Site
grade 3 tracheal secretions, number of suctionings and sputum neutrophil count on day 2; tracheal secretions on day 14/extubation; time to extubation and need for re-intubation; time to discharge; safety of of Kali bichromicums after 14 days/extubation. [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
grade 3 tracheal secretions, number of suctionings and sputum neutrophil count on day 2; tracheal secretions on day 14/extubation; time to extubation and need for re-intubation; time to discharge; safety of of Kali bichromicums after 14 days/extubation.
Not Provided
Not Provided
 
Effect of the Homeopathic Remedy Kalium Bichromicum (Potassium Dichromate) on Viscosity and Amount of Sputum and Time to Extubation in Mechanically Ventilated ICU Patients.
A Multicenter, Randomized, Double Blind, Placebo Controlled Trial to Investigate the Efficacy and Safety of the Homeopathic Remedy Kalium Bichromicum (Potassium Dichromate) to Decrease Viscosity and Amount of Sputum as Well as Time to Extubation, in Intubated Mechanically Ventilated ICU Patients.

ICU-Protocol.Summary Profuse and tenacious tracheal secretions are a significant factor impeding the weaning process in mechanically ventilated patients in the intensive care unit (ICU). In homeopathy, high dilutions of plant extracts, minerals, and other biological substances are used as remedies for the treatment of illness, which is based on the "Law of Similars" (the higher the dilution, the stronger the effect). Kali Bichromicum (potassium dichromate) is a drug that is commonly used in homeopathy, mostly for conditions involving profuse, stringy, tenacious mucous and tracheal secretions. A recent randomized, double-blind, placebo-controlled study found a statistically significant effect of this remedy on improving the amount of tracheal secretion, timing to extubation and discharge from the ICU among critically ill patients, with no side effects observed.

The proposed study will compare the efficacy of Kali bichromicum 10-60 (C30) versus placebo in reducing the amount of tracheal secretions in patients intubated with a conventional endotracheal tube or tracheostomy and receiving controlled mechanical ventilation in the ICU setting. The quantity of the secretions will be studied, as well as sputum neutrophil count (using direct microscopy). Time to extubation and the need for re-intubation will also be evaluated. 56 patients over the age of 18 years treated with mechanical ventilation for at least 3 days will be recruited from the ICU departments of 4 medical centers in Israel. The preparations will be administered in the form of small pellet-like globules, which will be placed on the mucosa of the mouth, to the side of the endotracheal tube. Patients will be randomly allocated to either verum (n=28) or placebo (n=28) treatment, with the remedies administered twice daily with an interval of 12 hours, for a period of up to 14 days or until the patient is extubated. Any adverse event will be recorded.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Mechanical Ventilation
  • Drug: Potassium Dichromate (Homeopathy)
    twice daily with an interval of 12 hours, for a period of up to 14 days
  • Drug: Placebo homeopathic remedy
    identical to treatment without active component
  • Experimental: 1
    potassium bichromate
    Intervention: Drug: Potassium Dichromate (Homeopathy)
  • Placebo Comparator: 2
    placebo
    Intervention: Drug: Placebo homeopathic remedy
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
56
December 2012
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • endotracheally intubated or tracheostomy ICU patient on mechanical ventilation support for at least 3 days prior to study enrollment, who is due for Spontaneous Breathing Trial (SBT).
  • profuse tenacious, stringy tracheal secretions (from 2+ to 4+)

Exclusion Criteria:

  • Unstable septic patients
  • Concomitant disease of the larynx and trachea obstructing the airway or inhibiting the extubation process.
  • active heart disease.
  • Need for catecholamines.
  • Pregnancy.
  • underlying neuromuscular disorder or any other condition preventing patient cooperation with voluntary coughing and expectoration of secretions.
  • underlying conditions requiring continuous therapy with bronchorrheic medications (i.e. myasthenia gravis)
  • Patients on home ventilation or BIPAP support
  • Failure of the patient or legal guardian to give written informed consent.
Both
18 Years and older
No
Contact: Menachem Oberbaum, M.D. 972-2-6666395 oberbaum@szmc.org.il
Israel
 
NCT00473473
KaliBic.ICU.07
No
Menachem Oberbaum, Shaare Zedek Medical Center
Shaare Zedek Medical Center
Hadassah Medical Organization
Principal Investigator: Menachem Oberbaum, M.D. Shaare Zedek Medical Center, Jerusalem, Israel
Study Director: Moshe Hersch, M.D. Intensive Care Unit, Shaare Zedek Medical Center, Jerusalem, Israel
Shaare Zedek Medical Center
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP