Perioperative Nitric Oxide Prevents Acute Kidney Injury in Acute Type A Aortic Dissection Patients

NCT06622291 | Completed Phase 4 DMC

• 3 other identifiers: 2024-16-20240626Z1911000066190952025AZB6001
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to determine the effectiveness of exogenous nitric oxide therapy in reducing the occurrence of acute kidney injury in patients with acute type A aortic dissection. Additionally, it aims to assess the safety of exogenous nitric oxide therapy.

Conditions

Acute Kidney Injury; Nitrous Oxide; Acute Type A Aortic Dissection

Keywords

Acute Kidney Injury; Nitrous Oxide; Aortic Dissection; cardiopulmonary bypass

Outcome Measures

Primary Outcomes (1)

• Acute kidney injury (AKI)

  Incidence of Acute Kidney injury. The presence of acute kidney injury (AKI) is assessed during 48 hours after surgery. AKI is defined as follows: an increase in serum creatinine ≥ 0.3 mg/dL (≥ 26.5 μM/L) during 48 hours after surgery; or an increase in serum creatinine by ≥ 1.5 times compared with the initial preoperative level for seven days after intervention; or urine output \< 0.5 mL/kg/h for 6 hours during the first 48 h after surgery.

  48 hours

Secondary Outcomes (11)

• AKI grade

  48 hours after surgery

• Urine output

  During CPB surgery, 12 and 24 hours after surgery

• Vasoactive-inotropic score

  immediate admission to ICU, 12 and 24 hours after surgery

• Neutrophil gelatinase-associated lipocalin concentration

  before surgery, immediate ICU admission, 12 and 24 hours after surgery

• Multiple organ failure

  24 hours after surgery

Other Outcomes (16)

• Dose of diuretics and recombinant human brain natriuretic peptide

  During CPB surgery, 12 and 24 hours after surgery

• Transfusions

  24 hours after surgery

• Renal Ultrasound

  immediate admission to ICU, 12 and 24 hours after surgery

Study Arms (2)

Nitric Oxide

EXPERIMENTAL

Patients in this group receive treatment with exogenous nitric oxide (NO) via the CPB machine. After CPB, NO is administered through the inspiratory limb of the anesthetic or ventilator circuit and then via the mechanical ventilator in the ICU. Once patients are extubated, they will breathe NO through a facemask or nasal cannula. NO administration begins at the start of CPB and continues for 12 hours post-operation.

Drug: Nitric Oxide

Usual care

PLACEBO COMPARATOR

Patients in this group receive a sham treatment without the supply of nitric oxide during CPB and for 12 hours post-operation.

Other: Placebo

Interventions

Nitric Oxide DRUG

Exogenous nitric oxide is directly administered to the oxygenator in the cardiopulmonary bypass circuit at a concentration of 60 ppm. Nitric oxide is also directly administered to the ventilator at a concentration of 60 ppm for 12 hours post-operation.

Nitric Oxide

Placebo OTHER

This is the placebo group. The standard CPB protocol involves delivering an air-gas mixture to the cardiopulmonary bypass circuit during cardiac surgery and avoiding the use of nitric oxide within 12 hours after surgery.

Usual care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide written informed consent;
• Participants must be over 18 years of age;
• Participants should meet the diagnostic and treatment guidelines for thoracic aortic diseases jointly issued by ACC/AHA in 2022, have received clinical and radiological diagnosis of acute type A aortic dissection, and undergone surgical thoracotomy within two weeks after symptom onset.

You may not qualify if:

• Missing baseline value or missing postoperative serum creatinine value (Scr);
• Preoperative eGFR less than 30ml/min/1.73m2 or receive renal replacement therapy;
• History of kidney disease, including glomerular diseases: acute glomerulonephritis, rapidly progressive glomerulonephritis, chronic glomerulonephritis, nephrotic syndrome, etc., secondary nephropathy: lupus nephritis, diabetic nephropathy, interstitial nephritis, renal tubular disease, chronic renal failure, renal replacement therapy, etc.;
• Previous renal tumor, kidney transplantation, and other related surgery;
• Patients with single kidney;
• History of malignant tumor or received radiotherapy and chemotherapy;
• Severe skeletal muscle disease and autoimmune disease;
• Preoperative dissection rupture or hemodynamic instability (systolic blood pressure \<90mmHg);
• Life expectancy less than 90 days;
• Pregnant and lactating women, patients with mental disorders;
• With intravascular or extravascular hemolytic disease;
• Have participated in other clinical trials.

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

Location

Related Publications (1)

• Chen Z, Han X, Li L, Liu M, Yu L, Cheng S, Yu Y, Liu N. Nitric oxide for the prevention of postoperative acute kidney injury in patients undergoing surgery for Stanford type A aortic dissection: study protocol for a randomized controlled trial. Trials. 2025 Aug 11;26(1):284. doi: 10.1186/s13063-025-08986-5.

  PMID: 40790609 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury; Aortic Dissection

Interventions

Nitric Oxide

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Single-center prospective, randomized, placebo-controlled study

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: October 2, 2024
• Study Start: November 30, 2024
• Primary Completion: November 1, 2025
• Study Completion: February 2, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Proposals may be submitted up to 6 months following publication of the results of the trial.
• Access Criteria: Information regarding submitting proposals and accessing data may be requested from the principal investigator by e-mail.

Locations

CN (1)