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

Mechanical Ventilation Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00473473
• Other study ID #: KaliBic.ICU.07
• Status: Recruiting
• Phase: Phase 3
• First received: May 14, 2007
• Last updated: February 19, 2012
• Start date: July 2008
• Est. completion date: December 2012

Study information

• Verified date: February 2012
• Source: Shaare Zedek Medical Center
• Contact: Menachem Oberbaum, M.D.
• Phone: 972-2-6666395
• Email: oberbaum[@]szmc.org.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mechanical Ventilation

Intervention

Drug:
• Potassium Dichromate (Homeopathy)
twice daily with an interval of 12 hours, for a period of up to 14 days
• Placebo homeopathic remedy
identical to treatment without active component

Locations

Country	Name	City	State
Israel	Dept. of Internal Medicine, Intensive Care Unit G8, Hadassah University Hospital, Ein Kerem	Jerusalem
Israel	Intensive Care Unit, Shaare Zedek Medical Center	Jerusalem

Sponsors (2)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center	Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		14 days	No
Secondary	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.		14 days	Yes