Nitric Oxide During Cardiopulmonary Bypass in Adult Surgery

NCT04807413 | Unknown Phase 3

• 1 other identifier: 0056-21
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Inhaled nitric oxide is a widely accepted standard of care for pulmonary hypertension, and has been studied in the context of cardiac surgery. CPB during cardiac surgery induces systemic inflammatory response and ischemic-reperfusion injury of many organs. Nitric oxide added to the bypass circuit may have anti-inflammatory effect and has shown the potential to ameliorate organs' injury . There is evidence that the delivery of nitric oxide to the oxygenator gas flow during pediatric CPB is accompanied by a reduction in myocardial injury markers' levels in the postoperative period. In adults, NO supply to the CPB circuit during CABG exerted a cardioprotective effect and was associated with a lower level of inotropic support and cardio-specific blood markers . To our knowledge, this is the first trial to assess whether artificial nitric oxide supplementation to the CPB-system reduces the incidence of hypoxemia after cardiac surgery.

Conditions

Hypoxia

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative hypoxemia

  Within 24 hours postoperatively

Secondary Outcomes (3)

• Incidence of Low cardiac output syndrome

  Within 72 postoperatively

• Use of drugs for hemodynamic support such as phenylephrine, noradrenaline

  Within 72 postoperatively

• Incidence of Acute Kidney Injury

  Within 72 postoperatively

Study Arms (2)

Study Arm: The balloon will be opened to deliver nitric oxide at 40 ppm.

EXPERIMENTAL

Nitric oxide balloon will be connected to the CPB machine. Participants randomized to this group will receive 40 ppm nitric oxide through the pump.

Drug: Nitric Oxide

Control Arm: The balloon will be closed and no nitric oxide will be delivered.

ACTIVE COMPARATOR

Participants in this group will receive standard of care treatment. Participation in the trial will not affect surgery management in any way.

Other: standard of care treatment

Interventions

Nitric Oxide DRUG

The balloon will be opened to deliver nitric oxide at 40 ppm through the cardiopulmonary bypass machine

Study Arm: The balloon will be opened to deliver nitric oxide at 40 ppm.

standard of care treatment OTHER

standard of care treatment

Control Arm: The balloon will be closed and no nitric oxide will be delivered.

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing elective CABG surgeries with CPB at Rabin Medical Center Beilinson hospital.
• Patients undergoing valve replacement/repair surgeries with CPB at Rabin Medical Center Beilinson hospital.

You may not qualify if:

• Patients requiring ECMO use preoperatively.
• Patients requiring IABP use preoperatively.
• Patients experiencing preoperative shock (defined as the need for ionotropic and/or vasopressor support).
• Patients after solid organ transplant surgery.
• Patients with LVAD.
• Patients with ESRD requiring dialysis preoperatively.
• Patients with a language barrier.
• Patients unable to give informed consent.
• Patients with heparin induced thrombocytopenia.

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Rabin Medical Center/Beilinson Campus

Petah Tikva, 49100, Israel

RECRUITING

Related Publications (1)

• Azem K, Novakovsky D, Krasulya B, Fein S, Iluz-Freundlich D, Uhanova J, Kornilov E, Eidelman LA, Kaptzon S, Gorfil D, Aravot D, Barac Y, Aranbitski R. Effect of nitric oxide delivery via cardiopulmonary bypass circuit on postoperative oxygenation in adults undergoing cardiac surgery (NOCARD trial): a randomised controlled trial. Eur J Anaesthesiol. 2024 Sep 1;41(9):677-686. doi: 10.1097/EJA.0000000000002022. Epub 2024 May 28.

  PMID: 39037709 DERIVED

MeSH Terms

Conditions

Hypoxia

Interventions

Nitric Oxide

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Reactive Nitrogen Species; Free Radicals; Inorganic Chemicals; Nitrogen Oxides; Nitrogen Compounds; Oxides; Oxygen Compounds; Organic Chemicals

Study Officials

• Leonid Eidelman

  Rabin Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leonid Eidelman, MD

CONTACT

97239376850; leidelman@clalit.org.il

Atara Davis, MD

CONTACT

972533321329; atarada@clalit.org.il

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: March 19, 2021
• Study Start: August 14, 2021
• Primary Completion: April 1, 2023
• Study Completion: May 1, 2023
• Last Updated: October 8, 2021

Record last verified: 2021-03

Locations

IL (1)