Homoeopathic Association in Aortic Valve Surgery (OMEO)

Preliminary Study of a Homoeopathic Association in Patients Undergoing Aortic Valve Surgery.

Randomized, parallel group, placebo controlled study to assess the effect of an homoeopathic association of Arnica 5 CH et Bryonia 9 CH during aortic valve surgery with extra corporeal circulation, to alleviate inflammation, haemorrhage, myocardial ischemia and pain. This is a pilot study; a confirmative study will be set up if this study is positive.

The study treatment will start the day before surgery, and will comprise 5 granules of each homoeopathic medication, Arnica 5 CH and Bryonia 9 CH, or their matching placebo TID during 5 days, in addition to all routine treatments.) Two groups of 45 patients will be included. Patients have to be over 18 years, to undergo aortic valve surgery only, have no known allergy to one of the study drugs, sign a consent form, and must not have received anti inflammatory drug in the 3 days before surgery. The primary criteria include the amount of drained liquid from the chest, and the CRP evolution from baseline to the 7th postoperative day. Secondary criteria address inflammation, haemorrhage, ischaemia, and pain. A follow-up phone call is given to the patients 30 days after their surgery.

Study Overview

• Status: Completed
• Conditions: Aortic Valve Replacement
• Intervention / Treatment: Drug: Arnica and Bryonia; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69003
    • Anaesthesy service, Louis Pradel Hospital

Participation Criteria

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:

• Patients over 18 years, undergoing aortic valve surgery with extra corporeal circulation

Exclusion Criteria:

• acute infectious or inflammatory concomitant disease, known allergy to one of the investigational products, Patients who did not sign the study consent form, patients having received during the 3 days before surgery any corticoids or non steroid anti-inflammatory drug, patient undergoing a surgery other than surgery of the aortic valve in the same intervention, patient undergoing an iterative cardiac surgery, patients under 18 years, patient over 18 years under the protection of the law.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Arnica 5CH and Bryonia 9CH (homeopathic drugs)	Drug: Arnica and Bryonia; Arnica 5CH granules, 5 per day plus Bryonia 5CH Granules, 5 per day for 5 days
Placebo Comparator: 2; placebo Arnica 5CH and Bryonia 9CH	Drug: placebo; 5 placebo granules for Arnica 5 CH and 5 placebo granules for Bryonia 5 CH

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Amount of drained liquid from the mediastinum or the pleura	At drain removal
plasma C reactive protein (CRP) at anaesthesia induction, plasma C reactive protein (CRP)	Day 2 and Day 7

Secondary Outcome Measures

Outcome Measure	Time Frame
Evolution of body temperature from before surgery to day 2 after surgery.	Day 2
Time from the end of extra corporeal circulation to closure of the thorax,	Closure of thorax
Amount of transfusions of erythrocytes, platelets, plasma.	Day 7
Visual analogical scale (VAS) for pain every 6 hours during stay in PACU, and every day afterwards to day 7,	To day 7
Amount of analgesic drugs, paracetamol and morphine.	Day 7
EKG before surgery, 24 and 48 hours after surgery.	48 hours
Plasma troponin I at induction of anaesthesia, 6, 24 and 48 hours after surgery.	48 hours
Quality of cicatrisation of sternotomy immediately after surgery, at day 2 and 7 after surgery, on a 4 point scale.	Day 7
Clinical events: death, new surgery for haemostasis or infection within 2 weeks of surgery, and any event occurring within 30 days after surgery.	30 days

Collaborators and Investigators

• Sponsor: BOIRON
• Collaborators: Hospices Civils de Lyon
• Investigators: Principal Investigator: Jean-Jacques Lehot, MD, Hospices Civils de Lyon, Lyon, France

Study record dates

Study Major Dates

• Study Start: September 1, 2004
• Primary Completion (Actual): June 1, 2007
• Study Completion (Actual): August 1, 2007

Study Registration Dates

• First Submitted: October 16, 2008
• First Submitted That Met QC Criteria: October 16, 2008
• First Posted (Estimate): October 17, 2008

Study Record Updates

• Last Update Posted (Estimate): October 17, 2008
• Last Update Submitted That Met QC Criteria: October 16, 2008
• Last Verified: October 1, 2008

More Information

Terms related to this study

• Keywords: randomized clinical trial; Homoeopathic treatment,; heart surgery,
• Other Study ID Numbers: Boiron 041052