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

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04020003
Enrollment
120
Registered
2019-07-15
Start date
2019-07-01
Completion date
2022-08-30
Last updated
2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ARDS, Human

Keywords

Levosimendan

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.

Interventions

DRUGLevosimendan

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.

Sponsors

Shenzhen Second People's Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Levosimendan group: on the basis of routine group treatment, 12.5 mg of levosimendan 5% s50ml 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.

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

Clinical diagnosis of ARDS; joined this study with informed consents

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
APACHE II scoreAdmission for 24 hoursThe 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 scoreAdmission for 7 daysThe total score is 0\ 48 points. The higher the score, the more serious the disease

Secondary

MeasureTime frameDescription
Mechanical ventilation timeFrom admission to 30 dayshow long did the patient stay in ICU
mecical expenseFrom admission to 30 dayshow much did the patient cost.

Countries

China

Contacts

Primary ContactMeng xinke, master
mengxinke_2006@126.com13751017051
Backup ContactXiang Lan, master
29206961@qq.com13603083203

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026