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Valvular StenosisPhase 2NCT00819377

Milrinone Inhaled in Cardiac Surgery

A Phase 2 study testing Milrinone and Normal saline in people with Valvular Stenosis and Valvular Insufficiency, run by Andre Denault at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Pulmonary hypertension is an important morbidity factor in patients having to undergo cardiac surgery with cardiopulmonary bypass (ECC). Milrinone used in inhalation, shows evidence of being a pulmonary vasodilator able to possibly contribute to the reduction of pressure on the pulmonary artery. Read more about this study

Who is it for?
Ages 18 to 90 years
What is being tested?
Milrinone and Normal saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
124 participants
Where
1 siteCanada
Study dates
Feb 2009to Dec 2012
Phase
Phase 2
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 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients scheduled for elective valvular or complex (2 or more valves or
  • valve and revascularization) cardiac surgery under CPB with preoperative PHT defined as mean pulmonary artery pressure (MPAP) over 30 mmHg or
  • systolic pulmonary artery pressure (SPAP) over 40 mmHg (using preoperative right-sided catheterization or estimated by echocardiography).

Who cannot join

  • Cardiac surgery not requiring CPB, contraindication to TEE (esophageal pathology or unstable cervical spine) and emergency surgery.
  • Patients will be recruited the day before surgery and randomized using computerized cards by the pharmacy department

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8

Other trials in Canada

About this study

Official title: 2- Inhaled Milrinone Prevents the Increase in Pulmonary Artery Pressure After CPB

Pulmonary hypertension is an important morbidity factor in patients having to undergo cardiac surgery with cardiopulmonary bypass (ECC). Milrinone used in inhalation, shows evidence of being a pulmonary vasodilator able to possibly contribute to the reduction of pressure on the pulmonary artery.

Read the detailed description

This controlled, randomized, double-blind study will aim at confirming the efficiency as well as the security of Milrinone, used in inhalation, to diminish the degree of pulmonary hypertension before the cardiopulmonary bypass (ECC) circulation. In addition, the pharmacokinetic and echo graphic repercussions of administering the medication will be analysed. At the present time, there is no data on the pharmacokinetics of the medication when it's administered through inhalation. For this reason, we would like to study the serous rate of the medication in the minutes following its administration through inhalation.

Being tested
Milrinone, Normal saline
Keywords
Valvular surgery, pulmonary artery pressure
Medical subject headings
Hypertension, Pulmonary, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MilrinoneDrug

    Also called Milrinone Cardiac Surgery, Milrinone inhaled, Inhaled milrinone reduces pulmonary artery pressure

    inhaled milrinone 5 mg (as for the injectable solution)

  • Normal salineDrug

    Also called Placebo, Comparator

    5 ml normal saline by inhalation over 15 min

Study groups in NCT00819377
Study groupRoleWhat they receive
Normal salinePlacebo comparatorNormal saline by inhalation over 15 min
Receives: Drug: Normal saline
MilrinoneActive comparatorInhaled milrinone 5 mg(as for the injectable solution)
Receives: Drug: Milrinone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To demonstrate that inhaled milrinone administered before CPB is superior to placebo in reducing the severity of difficult separation from bypass

    Measured: End of CPB

Secondary outcomes (5)

  1. Reduction in morbidity and mortality post-op

    Measured: At discharge, 3 months, 6 months and 1 year by telephone

  2. Reduction in pulmonary artery pressure

    Measured: Same day before and after CPB

  3. Right ventricular function measured using transthoracic echocardiography (TTE) and TEE

    Measured: Same day before and after the CPB

  4. Serum levels of milrinone in relation with the pharmacodynamic marker

    Measured: Same day pre CPB per CPB and post CPB

  5. reduction of the composite index of hemodynamic complications (defined as hospital death, vasoactive drugs > 24 hours and post-op cardiac arrest),

    Measured: 24 hrs post op and hospital discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2009 (estimated)
  2. Study startFeb 2009
  3. Primary completionJan 2012
  4. Study completionDec 2012

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
124 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00819377
Sponsor's protocol ID
08-1004
Status last verified
Oct 2013
First submitted
8 Jan 2009
Last updated
25 Oct 2013
Results posted
No
Data monitoring committee
No

Publications

  • Baim DS, McDowell AV, Cherniles J, Monrad ES, Parker JA, Edelson J, Braunwald E, Grossman W. Evaluation of a new bipyridine inotropic agent--milrinone--in patients with severe congestive heart failure. N Engl J Med. 1983 Sep 29;309(13):748-56. doi: 10.1056/NEJM198309293091302.

    PubMed 6888453

  • Denault AY, Lamarche Y, Couture P, Haddad F, Lambert J, Tardif JC, Perrault LP. Inhaled milrinone: a new alternative in cardiac surgery? Semin Cardiothorac Vasc Anesth. 2006 Dec;10(4):346-60. doi: 10.1177/1089253206294400.

    PubMed 17200091

  • Omae T, Kakihana Y, Mastunaga A, Tsuneyoshi I, Kawasaki K, Kanmura Y, Sakata R. Hemodynamic changes during off-pump coronary artery bypass anastomosis in patients with coexisting mitral regurgitation: improvement with milrinone. Anesth Analg. 2005 Jul;101(1):2-8, table of contents. doi: 10.1213/01.ANE.0000155262.37491.6A.

    PubMed 15976197

  • Kikura M, Levy JH, Michelsen LG, Shanewise JS, Bailey JM, Sadel SM, Szlam F. The effect of milrinone on hemodynamics and left ventricular function after emergence from cardiopulmonary bypass. Anesth Analg. 1997 Jul;85(1):16-22. doi: 10.1097/00000539-199707000-00004.

    PubMed 9212116

  • Lobato EB, Florete O Jr, Bingham HL. A single dose of milrinone facilitates separation from cardiopulmonary bypass in patients with pre-existing left ventricular dysfunction. Br J Anaesth. 1998 Nov;81(5):782-4. doi: 10.1093/bja/81.5.782.

    PubMed 10193294

  • Iwagaki T, Irie J, Ijichi K, Uratsuji Y. [The effects of milrinone on hemodynamics in patients undergoing cardiac surgery]. Masui. 2001 Apr;50(4):360-4. Japanese.

    PubMed 11345746

  • Shibata T, Suehiro S, Sasaki Y, Hosono M, Nishi S, Kinoshita H. Slow induction of milrinone after coronary artery bypass grafting. Ann Thorac Cardiovasc Surg. 2001 Feb;7(1):23-7.

    PubMed 11343562

  • Kim JH, Ham BM, Kim YL, Bahk JH, Ryu HG, Jeon YS, Kim KB. Prophylactic milrinone during OPCAB of posterior vessels: implication in angina patients taking beta-blockers. Eur J Cardiothorac Surg. 2003 Nov;24(5):770-6. doi: 10.1016/s1010-7940(03)00393-2.

    PubMed 14583311

  • Hoffman TM, Wernovsky G, Atz AM, Kulik TJ, Nelson DP, Chang AC, Bailey JM, Akbary A, Kocsis JF, Kaczmarek R, Spray TL, Wessel DL. Efficacy and safety of milrinone in preventing low cardiac output syndrome in infants and children after corrective surgery for congenital heart disease. Circulation. 2003 Feb 25;107(7):996-1002. doi: 10.1161/01.cir.0000051365.81920.28.

    PubMed 12600913

  • Maslow AD, Regan MM, Schwartz C, Bert A, Singh A. Inotropes improve right heart function in patients undergoing aortic valve replacement for aortic stenosis. Anesth Analg. 2004 Apr;98(4):891-902. doi: 10.1213/01.ANE.0000107940.23783.33.

    PubMed 15041568

  • Doolan LA, Jones EF, Kalman J, Buxton BF, Tonkin AM. A placebo-controlled trial verifying the efficacy of milrinone in weaning high-risk patients from cardiopulmonary bypass. J Cardiothorac Vasc Anesth. 1997 Feb;11(1):37-41. doi: 10.1016/s1053-0770(97)90250-0.

    PubMed 9058218

  • Yamada T, Takeda J, Katori N, Tsuzaki K, Ochiai R. Hemodynamic effects of milrinone during weaning from cardiopulmonary bypass: comparison of patients with a low and high prebypass cardiac index. J Cardiothorac Vasc Anesth. 2000 Aug;14(4):367-73. doi: 10.1053/jcan.2000.7920.

    PubMed 10972598

  • Solina A, Papp D, Ginsberg S, Krause T, Grubb W, Scholz P, Pena LL, Cody R. A comparison of inhaled nitric oxide and milrinone for the treatment of pulmonary hypertension in adult cardiac surgery patients. J Cardiothorac Vasc Anesth. 2000 Feb;14(1):12-7. doi: 10.1016/s1053-0770(00)90048-x.

    PubMed 10698385

  • Denault AY, Chaput M, Couture P, Hebert Y, Haddad F, Tardif JC. Dynamic right ventricular outflow tract obstruction in cardiac surgery. J Thorac Cardiovasc Surg. 2006 Jul;132(1):43-9. doi: 10.1016/j.jtcvs.2006.03.014.

    PubMed 16798301

  • Couture P, Denault AY, Pellerin M, Tardif JC. Milrinone enhances systolic, but not diastolic function during coronary artery bypass grafting surgery. Can J Anaesth. 2007 Jul;54(7):509-22. doi: 10.1007/BF03022314.

    PubMed 17602036

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Milrinone and Normal saline in people with Valvular Stenosis and Valvular Insufficiency, run by Andre Denault at 1 site in Canada.

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 3 inclusion and 2 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: finished, as of the sponsor's last update on 25 Oct 2013. 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 Canada. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To demonstrate that inhaled milrinone administered before CPB is superior to placebo in reducing the severity of difficult separation from bypass (time frame: End of CPB). 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 NCT00819377, which also lists 28 linked publications.

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 25 Oct 2013.

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