Mechanically Ventilated ICU PatientsPhase 3NCT00326365
Effect of Homeopathic Remedy Kalium Bichromicum on Viscosity and Amount of Sputum Mechanically Ventilated ICU Patients.
A Phase 3 study testing Kali bichromicum 10-60 (C30) in people with Mechanically Ventilated ICU Patients, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanically Ventilated ICU Patients
- What is being tested?
- Kali bichromicum 10-60 (C30)
- How many people
- 56 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2006to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- any endotracheally intubated ICU patient on mechanical ventilation support for at least 3 days prior to study enrollment.
- profuse tenacious, stringy tracheal secretions
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Intensive Care Unit, Shaare Zedek Medical Center
Jerusalem, 91031
Menachem Oberbaum, M.D., 972-2-6666395, oberbaum@szmc.org.il
About this study
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.
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.
Read the detailed description
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 and receiving controlled mechanical ventilation in the ICU setting. Both the quantity and viscoelasticity (measured by rheometry) 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
- Mechanically Ventilated ICU Patients
- Being tested
- Kali bichromicum 10-60 (C30)
- Keywords
- mechanical ventilation, secretions, viscosity, homeopathy, kalium bichromate, extubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kali bichromicum 10-60 (C30)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2006 (estimated)
- Study startJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mechanically Ventilated ICU PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Menachem Oberbaum, M.D., Principal investigator, Shaare Zedek Medical Center, Jerusalem, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00326365
- Sponsor's protocol ID
- KAL.ICU.2006
- Status last verified
- May 2006
- First submitted
- 15 May 2006
- Last updated
- 31 Oct 2007
- Results posted
- No
Publications
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.
PubMed 15764779
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00326365
- Acronym / sponsor ID
- KAL.ICU.2006
- Conditions
- Mechanically Ventilated ICU Patients
- Keywords
- mechanical ventilation, secretions, viscosity, homeopathy, kalium bichromate, extubation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Jun 2006
- First posted
- 16 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 and receiving controlled mechanical ventilation in the ICU setting. Both the quantity and viscoelasticity (measured by rheometry) 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- any endotracheally intubated ICU patient on mechanical ventilation support for at least 3 days prior to study enrollment.
- profuse tenacious, stringy tracheal secretions
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kali bichromicum 10-60 (C30) | Drug | – |
Primary outcome
To compare efficacy of Kali bichromicum (C30) in reducing tracheal secretions in mechanically ventilated patients
2 secondary outcomes
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2007.
- Background: PubMed 15764779Frass 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Menachem Oberbaum, M.D. principal investigator
Shaare Zedek Medical Center, Jerusalem, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Kali bichromicum 10-60 (C30) in people with Mechanically Ventilated ICU Patients, run by Shaare Zedek Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Menachem Oberbaum, M.D. (972-2-6666395, oberbaum@szmc.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare efficacy of Kali bichromicum (C30) in reducing tracheal secretions in mechanically ventilated patients. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00326365, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2007.