NCT04020003

A Clinical Study on Levosimendan Improvement of Prognosis of ARDS Patients by Optimizing Pulmonary Hemodynamics

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Shenzhen Second People's Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to evaluate the curative effect of Levosimendan on ARDS patients through omni-directional and multi-angle objective quantitative indexes, and to study the responsiveness of ARDS with or without right ventricular insufficiency to the treatment of Levosimendan, and to indirectly confirm whether Levosimendan had lung protective mechanism other than calcium sensitization to ARDS patients, such as inhibiting inflammatory reaction to reduce pulmonary capillary leakage and alveolar epithelial cell injury. Relaxation of bronchial smooth muscle improves pulmonary ventilation function. To provide new methods and ideas for clinical treatment of ARDS.

Detailed description

On the basis of the above research, the investigators speculate that Levosimendan can improve cardiac function, enhance diaphragm contractility and decrease pulmonary artery through this sensitizing effect, and protect ARDS lung function by regulating the release and oxidation of inflammatory mediators and nitroso oxidative stress. The hemodynamic and pulmonary protective effects of ARDS patients were improved by regulating K-ATP channels, relieving blood vessels and bronchospasm and improving ventilation and diffusion function in ARDS patients, so as to further improve the survival rate of these patients and shorten the mechanical ventilation time and ICU stay time. The purpose of this study was to observe the effect of Levosimendan on pulmonary circulation and right ventricular function in patients with ARDS, to determine whether it can reduce the fatality rate of ARDS and shorten its ICU residence time, and to evaluate the evaluation of ARDS with or without right ventricular insufficiency and to provide a new idea and method for drug treatment of ARDS.

Conditions

• ARDS, Human

Interventions

Type	Name	Description
DRUG	Levosimendan	General treatment group: control the infection, remove or control the original disease, mechanical ventilation, small tidal volume, high PEEP mechanical ventilation strategy, strictly control the capacity, strengthen the airway management, timely nutrition support and intensive rehabilitation treatment. Levosimendan group: on the basis of routine group treatment, 12.5 mg of levosimendan 5% GS 50ml was given on the same day, and the micro-pump was continuously pumped for 24 hours. The initial dose was 0.5 ml/ h, and if the blood pressure was not significantly decreased, the blood pressure was gradually increased to 2.4 ml/ h at the maximum dose, until the pump was over. The above treatment is repeated every 7 days until the offline success or the patient leaves the ICU.

Timeline

• Start date: 2019-07-01
• Primary completion: 2021-12-30
• Completion: 2022-08-30
• First posted: 2019-07-15
• Last updated: 2019-07-15

Locations

1 site across 1 country: China