Nitric Oxide for Reduced Intensive Support in Cardiac Surgery With Cardiopulmonary Bypass

PHASE3RecruitingINTERVENTIONAL
Enrollment

3,650

Participants

Timeline

Start Date

May 19, 2025

Primary Completion Date

March 31, 2028

Study Completion Date

March 31, 2029

Conditions
Nitric OxideCardiac SurgeryCardiopulmonary BypassAdult Patients Undergoing Cardiovascular Surgery With Cardiopulmonary Bypass
Interventions
DRUG

Nitric Oxide Gas

Patients will receive 80 parts per million (ppm) NO during CPB through the oxygenator. After weaning of CPB, test gases will be delivered via inspiration limb of ventilator at a dose range of 40-80 ppm until 6 hours after ICU admission or until extubation after surgery, whichever comes first.

DRUG

Standard Care Arm

Patients in this group will receive standard care and 80 ppm nitrogen (N2, control group) are added to the gas mixture as control. In the circumstances when the N2 is not applicable, such as when the plasma-chemical NO synthesis device is employed for NO generatiaon and delivery, the device will be connected to the CPB and ventilator circuits, but the synthesis will remain inactive in the control group. Consequently, the circuit will be supplied with air devoid of NO.

Trial Locations (3)

634012

NOT_YET_RECRUITING

Cardiology Research Institute, Tomsk National Research Medical Center, Tomsk

710032

RECRUITING

Xijing Hospital, Xi'an

02114

NOT_YET_RECRUITING

Massachusetts General Hospital, Department of Anesthesia, Critical Care and Pain Medicine, Boston

All Listed Sponsors
collaborator

Nikolay O. Kamenshchikov., M.D., Tomsk National Research Medical Center of the Russian Academy of Sciences

UNKNOWN

collaborator

Lorenzo Berra., M.D., Massachusetts General Hospital

UNKNOWN

collaborator

Jiange Han, Tianjin Chest Hospital, Tianjin, China

UNKNOWN

collaborator

Qingping Wu, Wuhan Union Hospital, Wuhan, China

UNKNOWN

collaborator

Evgeniy Grigoriev, Research Institute for Complex Issues of Cardiovascular Diseases, Kemerovo, Russian Federation

UNKNOWN

collaborator

Vladimir Boboshko, E. Meshalkin National Medical Research Center, Novosibirsk, Russian Federation

UNKNOWN

collaborator

Andrei Bautin, The Almazov National Medical Research Centre, St. Petersburg, Russian Federation

UNKNOWN

collaborator

Vladimir Pichugin, Specialized Cardiac Surgery Clinical Hospital named after Academician B.A. Korolev, Nizhny Novgorod, Russian Federation

UNKNOWN

collaborator

Evgeniy Rosseykin, Federal Center of Cardiovascular Surgery, Khabarovsk, Russian Federation

UNKNOWN

collaborator

Sheng Wang, Anzhen Hospital, Beijing, China

UNKNOWN

lead

Xijing Hospital

OTHER