Trial Outcomes & Findings for The Effects of Nitric Oxide for Inhalation During Left Ventricular Assists Device (LVAD) Implantation (NCT NCT00060840)
NCT ID: NCT00060840
Last Updated: 2016-08-22
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
150 participants
Primary outcome timeframe
28 days
Results posted on
2016-08-22
Participant Flow
There were 8 study medical centers that participated and enrolled subjects; 6 centers in the United States and 2 centers in Germany. There were 150 subjects enrolled in the study.
Participant milestones
| Measure |
Inhaled Nitric Oxide
Inhaled Nitric Oxide (iNO) administered through the INOvent delivery system to subjects at 40 parts per million (ppm) for up to 48 hours
|
Nitrogen
Nitrogen (N2) administered through the INOvent delivery system to subjects at 40 ppm for up to 48 hours.
|
|---|---|---|
|
Overall Study
STARTED
|
73
|
77
|
|
Overall Study
COMPLETED
|
69
|
68
|
|
Overall Study
NOT COMPLETED
|
4
|
9
|
Reasons for withdrawal
| Measure |
Inhaled Nitric Oxide
Inhaled Nitric Oxide (iNO) administered through the INOvent delivery system to subjects at 40 parts per million (ppm) for up to 48 hours
|
Nitrogen
Nitrogen (N2) administered through the INOvent delivery system to subjects at 40 ppm for up to 48 hours.
|
|---|---|---|
|
Overall Study
Change in surgical plan
|
2
|
6
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Subinvestigator unavailable
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Other
|
1
|
0
|
Baseline Characteristics
The Effects of Nitric Oxide for Inhalation During Left Ventricular Assists Device (LVAD) Implantation
Baseline characteristics by cohort
| Measure |
Inhaled Nitric Oxide
n=73 Participants
Inhaled Nitric Oxide (iNO) administered through the INOvent delivery system to subjects at 40 parts per million (ppm) for up to 48 hours
|
Nitrogen
n=77 Participants
Nitrogen (N2) administered through the INOvent delivery system to subjects at 40 ppm for up to 48 hours.
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
73 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
57.6 years
STANDARD_DEVIATION 9.75 • n=5 Participants
|
54.0 years
STANDARD_DEVIATION 11.95 • n=7 Participants
|
55.8 years
STANDARD_DEVIATION 11.04 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=5 Participants
|
42 participants
n=7 Participants
|
80 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
35 participants
n=5 Participants
|
35 participants
n=7 Participants
|
70 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: The analysis was determined for intent-to-treat population.
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.
Outcome measures
| Measure |
Inhaled Nitric Oxide
n=73 Participants
Inhaled Nitric Oxide (iNO) administered through the INOvent delivery system to subjects at 40 parts per million (ppm) for up to 48 hours
|
Nitrogen
n=77 Participants
Nitrogen (N2) administered through the INOvent delivery system to subjects at 40 ppm for up to 48 hours.
|
|---|---|---|
|
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.
|
7 Participants
|
12 Participants
|
Adverse Events
Inhaled Nitric Oxide
Serious events: 7 serious events
Other events: 14 other events
Deaths: 0 deaths
Nitrogen
Serious events: 11 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Inhaled Nitric Oxide
n=73 participants at risk
Inhaled Nitric Oxide (iNO) administered through the INOvent delivery system to subjects at 40 parts per million (ppm) for up to 48 hours
|
Nitrogen
n=77 participants at risk
Nitrogen (N2) administered through the INOvent delivery system to subjects at 40 ppm for up to 48 hours.
|
|---|---|---|
|
Cardiac disorders
Right Ventricular Failure
|
4.1%
3/73 • Number of events 3
|
3.9%
3/77 • Number of events 3
|
|
Injury, poisoning and procedural complications
Postprocedural hemorrhage
|
2.7%
2/73 • Number of events 2
|
3.9%
3/77 • Number of events 3
|
|
Vascular disorders
Hemorrhage
|
1.4%
1/73 • Number of events 1
|
3.9%
3/77 • Number of events 3
|
|
Injury, poisoning and procedural complications
Haemothorax
|
0.00%
0/73
|
1.3%
1/77 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/73
|
1.3%
1/77 • Number of events 1
|
|
Injury, poisoning and procedural complications
Procedural Complication
|
1.4%
1/73 • Number of events 1
|
0.00%
0/77
|
Other adverse events
| Measure |
Inhaled Nitric Oxide
n=73 participants at risk
Inhaled Nitric Oxide (iNO) administered through the INOvent delivery system to subjects at 40 parts per million (ppm) for up to 48 hours
|
Nitrogen
n=77 participants at risk
Nitrogen (N2) administered through the INOvent delivery system to subjects at 40 ppm for up to 48 hours.
|
|---|---|---|
|
Blood and lymphatic system disorders
Haemorrhagic Anaemia
|
0.00%
0/73
|
1.3%
1/77 • Number of events 1
|
|
Blood and lymphatic system disorders
Anaemia
|
1.4%
1/73 • Number of events 1
|
0.00%
0/77
|
|
Blood and lymphatic system disorders
Coagulopathy
|
1.4%
1/73 • Number of events 1
|
0.00%
0/77
|
|
Cardiac disorders
Atrial Fibrillation
|
1.4%
1/73 • Number of events 1
|
0.00%
0/77
|
|
Cardiac disorders
Right Ventricular Dysfunction
|
0.00%
0/73
|
1.3%
1/77 • Number of events 1
|
|
Cardiac disorders
Supraventricular Tachycardia
|
1.4%
1/73 • Number of events 1
|
0.00%
0/77
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.00%
0/73
|
1.3%
1/77 • Number of events 1
|
|
General disorders
Hypothermia
|
1.4%
1/73 • Number of events 1
|
0.00%
0/77
|
|
General disorders
Pyrexia
|
1.4%
1/73 • Number of events 1
|
0.00%
0/77
|
|
Investigations
Central Venous Pressure Decreased
|
1.4%
1/73 • Number of events 1
|
0.00%
0/77
|
|
Investigations
Alanine Aminotransferase Increased
|
1.4%
1/73 • Number of events 1
|
0.00%
0/77
|
|
Investigations
Aspartate Aminotransferase Abnormal
|
1.4%
1/73 • Number of events 1
|
0.00%
0/77
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.4%
1/73 • Number of events 1
|
0.00%
0/77
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
1.4%
1/73 • Number of events 1
|
0.00%
0/77
|
|
Renal and urinary disorders
Renal Failure Acute
|
1.4%
1/73 • Number of events 1
|
0.00%
0/77
|
|
Vascular disorders
Hypotension
|
1.4%
1/73 • Number of events 1
|
0.00%
0/77
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Disorder
|
0.00%
0/73
|
1.3%
1/77 • Number of events 1
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/73
|
1.3%
1/77 • Number of events 1
|
|
Injury, poisoning and procedural complications
Pharyngeal Injury
|
0.00%
0/73
|
1.3%
1/77 • Number of events 1
|
|
Vascular disorders
Haemodynamic Instability
|
1.4%
1/73 • Number of events 1
|
0.00%
0/77
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER