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

NCT00060840 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2016-08-22

Study results available
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Summary

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

Conditions

  • Congestive Heart Failure

Interventions

DRUG

Nitric Oxide

40 ppm of Nitric Oxide continuously administered for 48 hours

DRUG

Nitrogen

Nitrogen (N2) administered at 40 ppm for 48 hours

Sponsors & Collaborators

  • Mallinckrodt

    lead INDUSTRY

Principal Investigators

  • James Baldassarre, MD · Mallinckrodt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-07-31
Primary Completion
2008-06-30
Completion
2008-07-31

Countries

  • United States
  • Germany
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00060840 on ClinicalTrials.gov