- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04020003
A Clinical Study on Levosimendan Improvement of Prognosis of ARDS Patients by Optimizing Pulmonary Hemodynamics
July 11, 2019 updated by: Shenzhen Second People's Hospital
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.
Study Overview
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 Type
Interventional
Enrollment (Anticipated)
120
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Meng xinke, master
- Phone Number: 13751017051
- Email: mengxinke_2006@126.com
Study Contact Backup
- Name: Xiang Lan, master
- Phone Number: 13603083203
- Email: 29206961@qq.com
Study Locations
-
-
Guangdong
-
Shenzhen, Guangdong, China
- Recruiting
- Shenzhen Second People's Hospital
-
Contact:
- Nie Guohui, doctor
- Phone Number: 0755-83366388
-
Contact:
- Xie Ni
- Phone Number: 0755-83366388
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
APACHE II score
Time Frame: 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
|
Admission for 24 hours
|
SOFA score
Time Frame: Admission for 7 days
|
The total score is 0~48 points.
The higher the score, the more serious the disease
|
Admission for 7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mechanical ventilation time
Time Frame: From admission to 30 days
|
how long did the patient stay in ICU
|
From admission to 30 days
|
mecical expense
Time Frame: From admission to 30 days
|
how much did the patient cost.
|
From admission to 30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Feng yongwen, master, Shenzhen Second People's Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2019
Primary Completion (Anticipated)
December 30, 2021
Study Completion (Anticipated)
August 30, 2022
Study Registration Dates
First Submitted
July 2, 2019
First Submitted That Met QC Criteria
July 11, 2019
First Posted (Actual)
July 15, 2019
Study Record Updates
Last Update Posted (Actual)
July 15, 2019
Last Update Submitted That Met QC Criteria
July 11, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Respiration Disorders
- Lung Diseases
- Respiratory Distress Syndrome
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Enzyme Inhibitors
- Protective Agents
- Cardiotonic Agents
- Phosphodiesterase Inhibitors
- Phosphodiesterase 3 Inhibitors
- Simendan
Other Study ID Numbers
- 20193357016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified individual participant data for all primary and secondary outcome measures will be available.
IPD Sharing Time Frame
Date will be available within 6 months of study completion
IPD Sharing Access Criteria
Date assess requests will be reviewed by an external Independent Review Panel.
Requestors will be required to sign a Data Access Agreement.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Study Data/Documents
-
Individual Participant Data Set
Information identifier: mengxinke
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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