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

February 19, 2012 updated by: Menachem Oberbaum, Shaare Zedek Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

56

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Jerusalem, Israel, 91031
        • Recruiting
        • Intensive Care Unit, Shaare Zedek Medical Center
      • Jerusalem, Israel
        • Recruiting
        • Dept. of Internal Medicine, Intensive Care Unit G8, Hadassah University Hospital, Ein Kerem
        • Contact:
          • Sigal Svir, M.D.
          • Phone Number: 972-2-6777111

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
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
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaare Zedek Medical Center

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

May 14, 2007

First Submitted That Met QC Criteria

May 14, 2007

First Posted (Estimate)

May 15, 2007

Study Record Updates

Last Update Posted (Estimate)

February 22, 2012

Last Update Submitted That Met QC Criteria

February 19, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KaliBic.ICU.07

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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