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
  Purpose

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 Intervention Phase
Mechanical Ventilation
Drug: Potassium Dichromate (Homeopathy)
Drug: Placebo homeopathic remedy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 56
Study Start Date: July 2008
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00473473

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

Locations
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
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

Publications:
Responsible Party: Menachem Oberbaum, Director, Center for Integrative Complementary Medicine, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT00473473     History of Changes
Other Study ID Numbers: KaliBic.ICU.07
Study First Received: May 14, 2007
Last Updated: February 19, 2012
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Shaare Zedek Medical Center:
homeopathy
Traumeel
mechanical ventilation
secretions

ClinicalTrials.gov processed this record on October 02, 2014