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

NCT ID: NCT04020003

Last Updated: 2019-07-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2022-08-30

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.

Conditions

ARDS, Human

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Routine treatment

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.

Group Type: OTHER

Levosimendan

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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;

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenzhen Second People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Feng yongwen, master

Role: STUDY_CHAIR

Shenzhen Second People's Hospital

Locations

Shenzhen Second People's Hospital

Shenzhen, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Meng xinke, master

Role: CONTACT

mengxinke_2006@126.com

13751017051

Xiang Lan, master

Role: CONTACT

29206961@qq.com

13603083203

Facility Contacts

Nie Guohui, doctor

Role: primary

0755-83366388

Xie Ni

Role: backup

0755-83366388

References

Wang Q, Yokoo H, Takashina M, Sakata K, Ohashi W, Abedelzaher LA, Imaizumi T, Sakamoto T, Hattori K, Matsuda N, Hattori Y. Anti-Inflammatory Profile of Levosimendan in Cecal Ligation-Induced Septic Mice and in Lipopolysaccharide-Stimulated Macrophages. Crit Care Med. 2015 Nov;43(11):e508-20. doi: 10.1097/CCM.0000000000001269.

Reference Type: RESULT

PMID: 26468714 (View on PubMed)

Gordon AC, Perkins GD, Singer M, McAuley DF, Orme RM, Santhakumaran S, Mason AJ, Cross M, Al-Beidh F, Best-Lane J, Brealey D, Nutt CL, McNamee JJ, Reschreiter H, Breen A, Liu KD, Ashby D. Levosimendan for the Prevention of Acute Organ Dysfunction in Sepsis. N Engl J Med. 2016 Oct 27;375(17):1638-1648. doi: 10.1056/NEJMoa1609409. Epub 2016 Oct 5.

Reference Type: RESULT

PMID: 27705084 (View on PubMed)

Study Documents

Document Type: Individual Participant Data Set

View Document

Other Identifiers

20193357016

Identifier Type: -

Identifier Source: org_study_id