CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 150 enrolled
Drug / intervention
Nitric Oxide +1 moredrug
Likely dose
Nitric oxide 40 ppm continuously for 48 hoursAI-extracted
Key inclusion· 3
  • Scheduled to undergo first LVAD implantation, or at least 6 months after explanation of previous LVAD
  • Pulmonary vascular resistance ≥2.5 Wood units (200 dynes/sec) within 30 days prior to LVAD placement
  • Age >18 years
Key exclusion· 6
  • Congestive heart failure due to giant cell myocarditis or restrictive cardiomyopathy
  • Elective BiVAD surgery or current temporary BiVAD support
  • LVAD procedure expected without cardiopulmonary bypass
  • Pregnancy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00060840
NCT00060840Phase 2Completed

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

Mallinckrodt·interventional·Posted May 15, 2003·Updated Aug 22, 2016

In Brief

A Phase 2 clinical trial evaluating Nitric Oxide and Nitrogen for Congestive Heart Failure. Completed, enrolled 150 participants across 11 sites in 3 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 15, 2003
Enrollment StartJul 1, 2003
Primary CompletionJun 1, 2008
Study CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 23.1 years ago

Interventions

Nitric Oxidedrug

40 ppm of Nitric Oxide continuously administered for 48 hours

Nitrogendrug

Nitrogen (N2) administered at 40 ppm for 48 hours