Cardiogenic shock (VA-ECMO and IMPELLA support)
Conditions
Interventions
None listed
Sponsors
Okayasu Motohiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 years or older at the time of obtaining informed consent 2. Patients who provided informed consent If it is difficult to obtain informed consent from the patients, obtaining informed consent from their legal representative, etc. is acceptable. (Informed consent may be obtained after provisional registration only if it is difficult to obtain informed consent from the patients and immediate contact with their legal representative, etc. is not possible.) 3. Patients who meet the criteria for use of IMPELLA and VA-ECMO and have received treatment with both devices before the start of the administration of nitric oxide (irrespective of the type of IMPELLA) 4. Patients with pulmonary artery catheters 5. Patients who are scheduled to receive nitric oxide 6. Patients who have at least one retrospective PAPi under ECPELLA implantation from 12 hours before to the start of nitric oxide administration, in addition to the PAPi at immediately before the start of nitric oxide administration.
Exclusion criteria
Exclusion criteria: 1. Patients using MCS other than IMPELLA and VA-ECMO 2. Patients participating in other clinical trials, or studies using unapproved drugs 3. Other patients determined to be inappropriate as a participant by the investigators or sub-investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of nitric oxide in improving PAPi, changes in PAPi will be evaluated between 12 hours and immediately before the start of the administration of nitric oxide, and between immediately before and 12 hours after the start of nitric oxide (if nitric oxide is completed before 12 hours after the start of nitric oxide, the time of completion of nitric oxide) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Evaluation of efficacy 1. Pulmonary artery catheterization findings: 2. Blood gas analysis 3. Echocardiographic findings 4. MCS related findings 5. MCS alarm related 6. Number of survival days 7. Duration of VA-ECMO 8. Duration of IMPELLA - Safety assessment 1. Serious adverse events, adverse drug reactions 2. Methaemoglobin concentration | — |
Contacts
Public ContactChizuko Kamada
CMIC Co., Ltd.
Outcome results
None listed