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

NCT ID: NCT00473473

Last Updated: 2012-02-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2012-12-31

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.

Conditions

Mechanical Ventilation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

potassium bichromate

Group Type: EXPERIMENTAL

Potassium Dichromate (Homeopathy)

Intervention Type: DRUG

twice daily with an interval of 12 hours, for a period of up to 14 days

2

placebo

Group Type: PLACEBO_COMPARATOR

Placebo homeopathic remedy

Intervention Type: DRUG

identical to treatment without active component

Interventions

Potassium Dichromate (Homeopathy)

twice daily with an interval of 12 hours, for a period of up to 14 days

Intervention Type: DRUG

Placebo homeopathic remedy

identical to treatment without active component

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: collaborator

Shaare Zedek Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Menachem Oberbaum

Director, Center for Integrative Complementary Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Menachem Oberbaum, M.D.

Role: PRINCIPAL_INVESTIGATOR

Shaare Zedek Medical Center, Jerusalem, Israel

Moshe Hersch, M.D.

Role: STUDY_DIRECTOR

Intensive Care Unit, Shaare Zedek Medical Center, Jerusalem, Israel

Locations

Intensive Care Unit, Shaare Zedek Medical Center

Jerusalem, , Israel

Site Status: RECRUITING

Dept. of Internal Medicine, Intensive Care Unit G8, Hadassah University Hospital, Ein Kerem

Jerusalem, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Menachem Oberbaum, M.D.

Role: CONTACT

oberbaum@szmc.org.il

972-2-6666395

Facility Contacts

Sigal Svir, M.D.

Role: primary

972-2-6777111

References

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.

Reference Type: BACKGROUND

PMID: 15764779 (View on PubMed)

Other Identifiers

KaliBic.ICU.07

Identifier Type: -

Identifier Source: org_study_id