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Prophylactic Use of Levosimendan Versus Milrinone in Open Heart Surgery in Infants

NCT ID: NCT00549107

Last Updated: 2007-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Brief Summary

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Pediatric patients, especially infants undergoing open heart surgery have a predictable fall in cardiac index 6 to 18 hours after surgery, the so-called low cardiac output syndrome (LCOS). Patients, who have LCOS require more monitoring, more medication and a longer stay in intensive care unit. To prevent LCOS the phosphodiesterase inhibitor milrinone is routinely used during the first 24 hours after surgery. Levosimendan, a calcium- sensitizer improves cardiac muscle contractile force, vascular smooth muscle relaxation and coronary blood flow through calcium sensitization of the myocardial contractile filaments and opening of potassium channels without increasing oxygen consumption of the heart muscle cells. As the myocardium of infants is more calcium dependent than in later life, levosimendan should be of special benefit in this age group. The purpose of this study is to investigate whether levosimendan is superior to milrinone in preventing LCOS in infants after corrective open heart surgery.

Detailed Description

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Conditions

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Low Cardiac Output Syndrome

Keywords

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low cardiac output syndrome open heart surgery infants Low cardiac output syndrome in infants undergoing corrective open heart surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

Levosimendan

Intervention Type DRUG

2

Group Type ACTIVE_COMPARATOR

Milrinone

Intervention Type DRUG

Interventions

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Levosimendan

Intervention Type DRUG

Milrinone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age younger than one year
* corrective open heart surgery with biventricular repair, except tetralogy of fallot

Exclusion Criteria

* Missing written consent of parents
* Weight less than 3 kg
* preoperative LCOS
* gestational age less than 36 weeks
* preexisting renal failure
* preexisting thrombopenia
* preoperative cardiopulmonary resuscitation
* preoperative use of milrinone or levosimendan
Minimum Eligible Age

1 Day

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ludwig Boltzmann Gesellschaft

OTHER

Sponsor Role lead

Principal Investigators

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Evelyn Lechner, MD

Role: PRINCIPAL_INVESTIGATOR

Children´s Heart Center Linz

Hans Gombotz, MD, PHD

Role: STUDY_DIRECTOR

General Hospital Linz, Ludwig Boltzmann Gesellschaft

Anna Hofer, MD

Role: PRINCIPAL_INVESTIGATOR

General Hospital Linz

Gerald Tulzer, MD, PHD

Role: STUDY_CHAIR

Children´s Heart Center Linz

Locations

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Children´s Heart Center Linz

Linz, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Evelyn Lechner, MD

Role: CONTACT

Phone: +43505546324706

Email: [email protected]

Hans Gombotz, MD, PHD

Role: CONTACT

Phone: +4373278062157

Email: [email protected]

Facility Contacts

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Evelyn Lechner, MD

Role: primary

Anna Hofer, MD

Role: backup

References

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Wernovsky G, Wypij D, Jonas RA, Mayer JE Jr, Hanley FL, Hickey PR, Walsh AZ, Chang AC, Castaneda AR, Newburger JW, Wessel DL. Postoperative course and hemodynamic profile after the arterial switch operation in neonates and infants. A comparison of low-flow cardiopulmonary bypass and circulatory arrest. Circulation. 1995 Oct 15;92(8):2226-35. doi: 10.1161/01.cir.92.8.2226.

Reference Type BACKGROUND
PMID: 7554206 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12600913 (View on PubMed)

Turanlahti M, Boldt T, Palkama T, Antila S, Lehtonen L, Pesonen E. Pharmacokinetics of levosimendan in pediatric patients evaluated for cardiac surgery. Pediatr Crit Care Med. 2004 Sep;5(5):457-62. doi: 10.1097/01.pcc.0000137355.01277.9c.

Reference Type BACKGROUND
PMID: 15329162 (View on PubMed)

Egan JR, Clarke AJ, Williams S, Cole AD, Ayer J, Jacobe S, Chard RB, Winlaw DS. Levosimendan for low cardiac output: a pediatric experience. J Intensive Care Med. 2006 May-Jun;21(3):183-7. doi: 10.1177/0885066606287039.

Reference Type BACKGROUND
PMID: 16672640 (View on PubMed)

Namachivayam P, Crossland DS, Butt WW, Shekerdemian LS. Early experience with Levosimendan in children with ventricular dysfunction. Pediatr Crit Care Med. 2006 Sep;7(5):445-8. doi: 10.1097/01.PCC.0000235251.14491.75.

Reference Type BACKGROUND
PMID: 16885788 (View on PubMed)

Other Identifiers

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1-365

Identifier Type: -

Identifier Source: org_study_id