NCT05757557CompletedPhase 1/2
Perioperative Nitric Oxide Prevents Acute Kidney Injury in Cardiac Surgery Patients With Chronic Kidney Disease
Perioperative Nitric oxiDE-conditioning, Produced by Plasma-chemical Synthesis Technology, For prevEnt Acute kidNey Injury During carDiac surgEry in Patients With chRonic Kidney Disease (DEFENDER-trial)
Source: ClinicalTrials.gov · Last updated 23 Oct 2026
Brief summary (registry, in English)
The protective nitric oxide (NO) effects are mediated by selective pulmonary vasodilation and improvement of arterial oxygenation in hypoxemic patients by reducing intrapulmonary shunting and improving ventilation-perfusion coordination. Inhaled NO has been used for years to treat acute respiratory failure and pulmonary hypertension in anesthesia and intensive care. The nephroprotective role of NO was studied in an experimental model of contrast-induced nephropathy. The primary aim of this prospective, double-blind, randomized, parallel-group, controlled trial is to test the hypothesis that perioperative conditioning of patients with NO at a dose of 80 ppm, obtained by plasma-chemical synthesis technology, through a ventilator and an extracorporeal circulation circuit reduces the incidence of acute kidney injury (AKI) in patients with an initially high risk of kidney damage due to the presence of preoperative chronic kidney disease (CKD). The study is interventional. Examination and treatment of patients is carried out in accordance with the approved standards of medical care for the relevant diseases. During the study, no experimental or unregistered (not approved for use) medical or diagnostic procedures in the territory of the Russian Federation will be carried out. The study includes patients admitted to the Cardiac Surgery Department of Cardiology Research Institute of Tomsk NRMC for elective surgery with high risk of AKI in the perioperative period
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 136 (actual)
- First submitted
- 11 Feb 2023
- Start date
- 25 Feb 2023
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
- Diseases
- Chronic kidney disease
- NCT number
- NCT05757557
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 136
- From 25 Feb 2023 to the primary completion date, 31 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Emergency surgery (including that in ACS)
- Administration of potentially nephrotoxic drugs within 24 hours before surgery (radiocontrast agents, antimicrobial therapy with aminoglycosides and / or amphotericin)
- Previous randomization in DEFENDER trial
Other illness
- Pulmonary hypertension higher than stage II (systolic pulmonary pressure over 65 mmHg according to data of preoperative transthoracic echocardiography
- Condition after kidney transplantation
- Cardiac surgery with hypothermic circulatory arrest
Lab values
- Left ventricular ejection fraction \< 30%
Other
- cGFR \<15 mL/min/1.73 m2
- Critical preoperative status (preoperative need for mechanical ventilation, inotropes, circulatory support)
- Pregnancy
- Ongoing enrolment in other randomized clinical trial
- Active endocarditis and/or sepsis
- Ongoing AKI caused by glomerulonephritis, interstitial nephritis, renal artery occlusion, or postrenal occlusion
- Single kidney
Who the study is looking for
- Cardiac surgery with CPB
- Age \> 18 years
- Signed informed consent
- CKD (cGFR \<60 mL/min/1.73 m2)
- Positive decision of council of physicians on individual safety of perioperative administration of NO
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences Coordinator of this site? Confirm its status | Tomsk | Russia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.