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

NCT00473473 | Unknown Phase 3

• 1 other identifier: KaliBic.ICU.07
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 2

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

Keywords

homeopathy; Traumeel; mechanical ventilation; secretions

Outcome Measures

Primary Outcomes (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.

  14 days

Secondary Outcomes (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.

  14 days

Study Arms (2)

1

EXPERIMENTAL

potassium bichromate

Drug: Potassium Dichromate (Homeopathy)

2

PLACEBO COMPARATOR

placebo

Drug: Placebo homeopathic remedy

Interventions

Potassium Dichromate (Homeopathy) DRUG

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

1

Placebo homeopathic remedy DRUG

identical to treatment without active component

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead
• Hadassah Medical Organization: collaborator

Study Sites (2)

Intensive Care Unit, Shaare Zedek Medical Center

Jerusalem, 91031, Israel

RECRUITING

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

Jerusalem, Israel

RECRUITING

Related 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. doi: 10.1378/chest.127.3.936.

  PMID: 15764779 BACKGROUND

MeSH Terms

Interventions

Potassium Dichromate; Homeopathy

Intervention Hierarchy (Ancestors)

Chromates; Chromium Compounds; Inorganic Chemicals; Potassium Compounds; Complementary Therapies; Therapeutics

Study Officials

• Menachem Oberbaum, M.D.

  Shaare Zedek Medical Center, Jerusalem, Israel

  PRINCIPAL INVESTIGATOR

• Moshe Hersch, M.D.

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

  STUDY DIRECTOR

Central Study Contacts

Menachem Oberbaum, M.D.

CONTACT

972-2-6666395; oberbaum@szmc.org.il

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Integrative Complementary Medicine

Study Record Dates

• First Submitted: May 14, 2007
• First Posted: May 15, 2007
• Study Start: July 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 22, 2012

Record last verified: 2012-02

Locations

IL (2)