The Effects of Nitric Oxide for Inhalation During Left Ventricular Assists Device (LVAD) Implantation

The purpose of this study is to assess the utility of nitric oxide for inhalation during left ventricular assist device (LVAD) implantation following cardiopulmonary bypass (CPB). This is to be assessed by the number of patients in each treatment group meeting failure criteria within 24 hours on study drug, as defined by two or more of the following:

* Left ventricular flow rate index (LVFRI) ≤ 2.0 L/min/m^2 * Administration of ≥ 20 inotropic equivalents (IE)

* 10 µg/kg/min dopamine, dobutamine, enoximone or amrinone is equivalent to 10 IE * 0.1 µg/kg/min epinephrine or norepinephrine is equivalent to 10 IE * 1 µg/kg/min milrinone is equivalent to 15 IE * 0.1 U/min vasopressin is equivalent to 10 IE * Mean arterial pressure (MAP) ≤ 55 mmHg * Central venous pressure (CVP) ≥ 16 mmHg * Percent mixed venous oxygen saturation (SvO2) ≤ 55%

Or at least one of the following criteria:

* Failure to wean from cardiopulmonary bypass at least once due to hemodynamic failure. Re-initiation of cardiopulmonary bypass to correct bleeding or other technical issues will not be considere 'failure to wean' * Death

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Key information

Conditions

Congestive Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Herz-und Diabeteszentrum Nordrhein-Westfalen, Gergstrab, Bad Oeynhausen, Germany

About this study

40 ppm of either nitric oxide for inhalation or N2 (placebo) will be continuously administered to the patient starting at least 5 minutes prior to initiating the first weaning attempt from CPB and continue until the patient is either extubated, has reached failure criteria, or has been treated with study drug for 48 hours following discontinuation of CPB, whichever come first.

All patients will be monitored peri-operatively with a pulmonary arterial line, central venous line, and systemic arterial line. Baseline data collection by a designated clinical staff member will begin following induction of anesthesia and prior to skin incision. Following a successful wean from cardiopulmonary bypass, post-op data will be collected within 1 hour following end time of surgery. Data will then be collected at 6, 12, 18, 24, and 48 hours from post-op or until extubation, in which case weaning from study drug will begin.

Open label investigational nitric oxide for inhalation may be administered once a patient meets a minimum of two of the failure criteria or fails to wean at least once due to hemodynamic failure from cardiopulmonary bypass.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Scheduled to undergo their first LVAD implantation, (or at least 6 months after explanation of a previous LVAD).
Has a pulmonary vascular resistance of at least 2.5 Wood units (200 dynes/sec.) in the 30 days prior to LVAD placement.
Greater than 18 years of age.
Signed IRB approved informed consent.

Exclusion criteria

Patients with congestive heart failure due to giant cell myocarditis or restrictive cardiomyopathy.
Elective Biventricular Assist Device (BiVAD) surgery, or current support with a temporary BiVad.
LVAD procedure expected to be done without cardiopulmonary bypass.
Pregnancy (a negative pregnancy test must be documented prior to enrollment).
Received nitric oxide by inhalation therapy within the past 24 hours.
Investigational drugs that are expected to change systemic or pulmonary vascular resistance are not allowed.

Treatment and study plan

nitric oxide

Drug

40 ppm of Nitric Oxide continuously administered for 48 hours

Other names: INOmax

Nitrogen

Drug

Nitrogen (N2) administered at 40 ppm for 48 hours

Primary outcomes

The Number of Subjects With Left Ventricular Failure During Left Ventricular Assistance Device (LVAD) Placement After Cardio Pulmonary Bypass, as Determined by Failure Criteria, After Administration of Nitric Oxide.

Time frame: 28 days
Failure criteria used to measure outcome includes:
- Left ventricular flow rate index (LVFRI) ≤ 2.0 L/min/m^2
- Administration of ≥ 20 inotropic equivalents (IE)
- Mean arterial pressure (MAP) ≤ 55 mm Hg
- Central venous pressure (CVP) ≥ 16 mm Hg
- Percentage of mixed venous oxygen saturation (SvO2) of ≤ 55% OR failure to wean from cardio pulmonary bypass (CPB) at least once due to hemodynamic failure or death.

Sponsors and collaborators

Lead sponsor

Mallinckrodt

Industry

Registry information

Official study title

The Effects of Nitric Oxide for Inhalation During Left Ventricular Assist Device (LVAD) Implantation

Important dates

Study start: 2003
Primary completion: 2008
Study completion: 2008
First posted: May 15, 2003
Registry last updated: Aug 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed