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

Phase 3

• Conditions: ARDS, Human
• Interventions: Drug: Levosimendan

• Registration Number: NCT04020003
• Lead Sponsor: Shenzhen Second People's Hospital

Brief 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.

Study Timeline

• Status Verified: 2019-07
• Study Start: 2019-07-01
• Study First Submitted: 2019-07-02
• Study First Submitted QC: 2019-07-11
• Last Update Submitted: 2019-07-11
• Study First Posted: 2019-07-15
• Last Update Posted: 2019-07-15
• Primary Completion: 2021-12-30
• Study Completion: 2022-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Clinical diagnosis of ARDS; joined this study with informed consents

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Exclusion Criteria

neurological and muscle diseases; Chronic severe liver and kidney failure; advanced malignant tumor; Primary left ventricular insufficiency;

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Routine treatment	Levosimendan	Routine treatment group: control infection, remove or control the primary disease; mechanical ventilation with low tidal volume and high PEEP mechanical ventilation strategy; strictly control volume, strengthen airway management, timely nutritional support and severe rehabilitation treatment.

Primary Outcome Measures

Name	Time	Method
APACHE II score	Admission for 24 hours	The lowest value in the first 24 hours after entering ICU. The total score is 0\~71 points. The higher the score, the more serious the disease
SOFA score	Admission for 7 days	The total score is 0\~48 points. The higher the score, the more serious the disease

Secondary Outcome Measures

Name	Time	Method
mecical expense	From admission to 30 days	how much did the patient cost.
Mechanical ventilation time	From admission to 30 days	how long did the patient stay in ICU

Trial Locations

Locations (1)

Shenzhen Second People's Hospital; 🇨🇳 Shenzhen, Guangdong, China