SUPPORT-pVAD

JRCT ID: jRCT1061230015

Registered date:20/05/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Cardiogenic shock
• Date of first enrollment: 20/05/2023
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Inhaled nitric oxide (20ppm 10min, 40ppm 5min)

Outcome(s)

• Primary Outcome: Change of cardiac index ( LaFarge-Miettien fomula) from baseline to 15 minutes after intervention.

Secondary Outcome

1. change of mean pulmonary artery pressure
2. change of pulmonary vascular resistance
3. change of cardiac power output

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. 18 years-old or older
2. Signed and dated written informed consent
3. Cardiogenic shock
4. Supported with Impella 5.5, Impella CP
5. Indwelled with Pulmonary artery catheter

Exclude criteria

1. Using other mechanical circulatory support device except Impella 5.5 and Impella CP
2. Using nitroprusside, nitroglycerin, or sulfonamide
3. Pregnant or breastfeeding
4. Dependent on right to left shunt
5. Allergy to nitric oxide
6. Systolic blood pressure less than 90 mmHg
7. Judged as inappropriate by researchers

Related Information

• Primary Sponsor: Kazufumi Nakamura
• Source(s) of Monetary Support: The Ministry of Education, Science, Sports and Culture, Grant-in-Aid for Scientific Research
• Secondary ID(s): Nil known