NCT00326365

Brief Summary

The purpose of this study is to determine whether the homeopathic remedy Kali Bichromium is effective in reducing the amount of tracheal secretions in patients intubated with a conventional endotracheal tube and receiving controlled mechanical ventilation in the ICU setting.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at below P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 16, 2006

Completed
16 days until next milestone

Study Start

First participant enrolled

June 1, 2006

Completed
Last Updated

October 31, 2007

Status Verified

May 1, 2006

First QC Date

May 15, 2006

Last Update Submit

October 30, 2007

Conditions

Mechanically Ventilated ICU Patients

Keywords

mechanical ventilationsecretionsviscosityhomeopathykalium bichromateextubation

Outcome Measures

Primary Outcomes (1)

  • To compare efficacy of Kali bichromicum (C30) in reducing tracheal secretions in mechanically ventilated patients

Secondary Outcomes (2)

  • To compare the proportion of patients with grade 3 tracheal secretions;number of suctionings;reduction of tracheal secretions;effects on the mucus viscoelasticity and sputum neutrophil count; shortening time to extubation and need for re-intubation.

  • effect in shortening the time to discharge from the ICU. To evaluate the safety of of Kali bichromicum 10-60 (C30) as compared with placebo.

Interventions

Kali bichromicum 10-60 (C30)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • any endotracheally intubated ICU patient on mechanical ventilation support for at least 3 days prior to study enrollment.
  • profuse tenacious, stringy tracheal secretions

You may not qualify if:

  • Unstable septic patients
  • Concomitant disease of the larynx and trachea obstructing the airway or inhibiting the extubation process.
  • Patients with Tracheostomy
  • Concomitant active heart disease.
  • Need for catecholamines.
  • Pregnancy.
  • Patient with underlying neuromuscular disorder or any other condition preventing patient cooperation with voluntary coughing and expectoration of secretions.
  • Patients with underlying conditions requiring continuous therapy with bronchorrheic medications (i.e. myasthenia gravis)
  • Failure of the patient or legal guardian to give written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intensive Care Unit, Shaare Zedek Medical Center

Jerusalem, 91031, Israel

Location

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: 15764779BACKGROUND

Study Officials

  • Menachem Oberbaum, M.D.

    Shaare Zedek Medical Center, Jerusalem, Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Menachem Oberbaum, M.D.

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 15, 2006

First Posted

May 16, 2006

Study Start

June 1, 2006

Last Updated

October 31, 2007

Record last verified: 2006-05

Locations

IL(1)