Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00060840
Status:
COMPLETED
Last Update Posted:
2016-08-22
First Post:
2003-05-14
Brief Title:
The Effects of Nitric Oxide for Inhalation During Left Ventricular Assists Device LVAD Implantation
Sponsor:
Mallinckrodt
Organization:
Mallinckrodt
Study Overview
Official Title:
The Effects of Nitric Oxide for Inhalation During Left Ventricular Assist Device LVAD Implantation
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 20 Lminm2
Administration of 20 inotropic equivalents IE
10 µgkgmin dopamine dobutamine enoximone or amrinone is equivalent to 10 IE
01 µgkgmin epinephrine or norepinephrine is equivalent to 10 IE
1 µgkgmin milrinone is equivalent to 15 IE
01 Umin 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
Left ventricular flow rate index LVFRI 20 Lminm2
Administration of 20 inotropic equivalents IE
10 µgkgmin dopamine dobutamine enoximone or amrinone is equivalent to 10 IE
01 µgkgmin epinephrine or norepinephrine is equivalent to 10 IE
1 µgkgmin milrinone is equivalent to 15 IE
01 Umin 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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None