Clinical trial NCT00774293: Homoeopathic Association in Aortic Valve Surgery
Official title: Preliminary Study of a Homoeopathic Association in Patients Undergoing Aortic Valve Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Aortic Valve Replacement
Keywords: Homoeopathic treatment,
heart surgery,
randomized clinical trial
Lead sponsor: BOIRON
Sponsor class: INDUSTRY
Collaborators: name: Hospices Civils de Lyon
First posted: 2008-10-17
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Amount of drained liquid from the mediastinum or the pleura
timeFrame: At drain removal
measure: plasma C reactive protein (CRP) at anaesthesia induction, plasma C reactive protein (CRP)
timeFrame: Day 2 and Day 7
Secondary outcomes:
measure: Evolution of body temperature from before surgery to day 2 after surgery.
timeFrame: Day 2
measure: Time from the end of extra corporeal circulation to closure of the thorax,
timeFrame: Closure of thorax
measure: Amount of transfusions of erythrocytes, platelets, plasma.
timeFrame: Day 7
measure: Visual analogical scale (VAS) for pain every 6 hours during stay in PACU, and every day afterwards to day 7,
timeFrame: To day 7
measure: Amount of analgesic drugs, paracetamol and morphine.
timeFrame: Day 7
measure: EKG before surgery, 24 and 48 hours after surgery.
timeFrame: 48 hours
measure: Plasma troponin I at induction of anaesthesia, 6, 24 and 48 hours after surgery.
timeFrame: 48 hours
measure: Quality of cicatrisation of sternotomy immediately after surgery, at day 2 and 7 after surgery, on a 4 point scale.
timeFrame: Day 7
measure: Clinical events: death, new surgery for haemostasis or infection within 2 weeks of surgery, and any event occurring within 30 days after surgery.
timeFrame: 30 days
Other outcomes:
Locations:
city: Lyon
country: France
facility: Anaesthesy service, Louis Pradel Hospital
Study officials:
affiliation: Hospices Civils de Lyon, Lyon, France
name: Jean-Jacques Lehot, MD
role: PRINCIPAL_INVESTIGATOR
References: