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Prophylactic Use of Levosimendan Versus Milrinone in Open Heart Surgery in Infants (Levomil)

Primary Purpose

Low Cardiac Output Syndrome

Status

Unknown status

Phase

Phase 2

Locations

Austria

Study Type

Interventional

Intervention

Levosimendan

Milrinone

About this trial

This is an interventional treatment trial for Low Cardiac Output Syndrome focused on measuring low cardiac output syndrome, open heart surgery, infants, Low cardiac output syndrome in infants undergoing corrective open heart surgery

Eligibility Criteria

1 Day - 12 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Children´s Heart Center LinzRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Cardiac output measured by a transesophageal probe

Secondary Outcome Measures

Changes in mixed venous saturation

Serum lactate levels

Cardiac output and ventricular function assessed by echocardiography

Mean arterial, left atrial and central venous pressure

Need of catecholamines assessed with the inotropic score

Urine output

Full Information

NCT ID

NCT00549107

First Posted

October 24, 2007

Last Updated

October 24, 2007

Sponsor

Ludwig Boltzmann Gesellschaft

1. Study Identification

Unique Protocol Identification Number

NCT00549107

Brief Title

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

Acronym

Levomil

Official Title

Phase 2 Prospective, Randomized, Double-Blind Pilot Study on Cardiac Output Following Corrective Open Heart Surgery in Children Less Than One Year: Use of Levosimendan Versus Milrinone.

Study Type

Interventional

2. Study Status

Record Verification Date

October 2007

Overall Recruitment Status

Unknown status

Study Start Date

September 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Ludwig Boltzmann Gesellschaft

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Cardiac Output Syndrome

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Levosimendan

Intervention Type

Drug

Intervention Name(s)

Milrinone

Primary Outcome Measure Information:

Title

Cardiac output measured by a transesophageal probe

Time Frame

48 hours

Secondary Outcome Measure Information:

Title

Changes in mixed venous saturation

Time Frame

48 hours

Title

Serum lactate levels

Time Frame

48 hours

Title

Cardiac output and ventricular function assessed by echocardiography

Time Frame

48 hours

Title

Mean arterial, left atrial and central venous pressure

Time Frame

48 hours

Title

Need of catecholamines assessed with the inotropic score

Time Frame

48 hours

Title

Urine output

Time Frame

48 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Day

Maximum Age & Unit of Time

12 Months

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Evelyn Lechner, MD

Phone

+43505546324706

elechner@aon.at

First Name & Middle Initial & Last Name or Official Title & Degree

Hans Gombotz, MD, PHD

Phone

+4373278062157

hans.gombotz@akh.linz.at

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Evelyn Lechner, MD

Organizational Affiliation

Children´s Heart Center Linz

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Hans Gombotz, MD, PHD

Organizational Affiliation

General Hospital Linz, Ludwig Boltzmann Gesellschaft

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Anna Hofer, MD

Organizational Affiliation

General Hospital Linz

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Gerald Tulzer, MD, PHD

Organizational Affiliation

Children´s Heart Center Linz

Official's Role

Study Chair

Facility Information:

Facility Name

Children´s Heart Center Linz

City

Linz

ZIP/Postal Code

4020

Country

Austria

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Evelyn Lechner, MD

elechner@aon.at

First Name & Middle Initial & Last Name & Degree

Anna Hofer, MD

anna.hofer@akh.linzat

First Name & Middle Initial & Last Name & Degree

Evelyn Lechner, MD

First Name & Middle Initial & Last Name & Degree

Anna Hofer, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

7554206

Citation

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.

Results Reference

background

PubMed Identifier

12600913

Citation

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.

Results Reference

background

PubMed Identifier

15329162

Citation

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.

Results Reference

background

PubMed Identifier

16672640

Citation

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.

Results Reference

background

PubMed Identifier

16885788

Citation

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. Erratum In: Pediatr Crit Care Med. 2007 Mar;8(2):197.

Results Reference

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

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