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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.

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ClinicalTrials.gov Identifier: NCT00473473
Recruitment Status : Unknown
Verified February 2012 by Menachem Oberbaum, Shaare Zedek Medical Center.
Recruitment status was:  Recruiting
First Posted : May 15, 2007
Last Update Posted : February 22, 2012
Sponsor:
Collaborator:
Hadassah Medical Organization
Information provided by (Responsible Party):
Menachem Oberbaum, Shaare Zedek Medical Center

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Mechanical Ventilation Drug: Potassium Dichromate (Homeopathy) Drug: Placebo homeopathic remedy Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : July 2008
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
potassium bichromate
 Drug: Potassium Dichromate (Homeopathy)
twice daily with an interval of 12 hours, for a period of up to 14 days
Placebo Comparator: 2
placebo
 Drug: Placebo homeopathic remedy
identical to treatment without active component


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00473473


Contacts
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Contact: Menachem Oberbaum, M.D. 972-2-6666395 oberbaum@szmc.org.il

Locations
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Israel
Intensive Care Unit, Shaare Zedek Medical Center Recruiting
Jerusalem, Israel, 91031
Dept. of Internal Medicine, Intensive Care Unit G8, Hadassah University Hospital, Ein Kerem Recruiting
Jerusalem, Israel
Contact: Sigal Svir, M.D.    972-2-6777111      
Sponsors and Collaborators
Shaare Zedek Medical Center
Hadassah Medical Organization
Investigators
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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
More Information
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Publications:

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Responsible Party: Menachem Oberbaum, Director, Center for Integrative Complementary Medicine, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT00473473    
Other Study ID Numbers: KaliBic.ICU.07
First Posted: May 15, 2007    Key Record Dates
Last Update Posted: February 22, 2012
Last Verified: February 2012
Keywords provided by Menachem Oberbaum, Shaare Zedek Medical Center:
homeopathy
Traumeel
mechanical ventilation
secretions