ARDS, HumanPhase 3NCT04020003
A Clinical Study on Levosimendan Improvement of Prognosis of ARDS Patients by Optimizing Pulmonary Hemodynamics
A Phase 3 study testing Levosimendan in people with ARDS, Human, run by Shenzhen Second People's Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ARDS, Human
- What is being tested?
- Levosimendan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2019to 30 Aug 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of ARDS; joined this study with informed consents
Who cannot join
- neurological and muscle diseases; Chronic severe liver and kidney failure; advanced malignant tumor; Primary left ventricular insufficiency;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shenzhen Second People's Hospital
Shenzhen, Guangdong
Nie Guohui, doctor, 0755-83366388
Xie Ni, 0755-83366388
About this study
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.
Read the 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
- Being tested
- Levosimendan
- Keywords
- Levosimendan
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevosimendanDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Routine treatment | Other | 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. Receives: Drug: Levosimendan |
What is being measured
The primary outcome is the main question the study is designed to answer.
APACHE II score
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
Measured: Admission for 24 hours
SOFA score
The total score is 0~48 points. The higher the score, the more serious the disease
Measured: Admission for 7 days
Secondary outcomes (2)
Mechanical ventilation time
how long did the patient stay in ICU
Measured: From admission to 30 days
mecical expense
how much did the patient cost.
Measured: From admission to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start1 Jul 2019
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ARDS, HumanStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Second People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Feng yongwen, master, Study chair, Shenzhen Second People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04020003
- Sponsor's protocol ID
- 20193357016
- Status last verified
- Jul 2019
- First submitted
- 2 Jul 2019
- Last updated
- 15 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be available.
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.
PubMed 26468714Gordon 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.
PubMed 27705084
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on Levosimendan Improvement of Prognosis of ARDS Patients by Optimizing Pulmonary Hemodynamics
- ClinicalTrials.gov ID
- NCT04020003
- Acronym / sponsor ID
- 20193357016
- Conditions
- ARDS, Human
- Keywords
- Levosimendan
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shenzhen Second People's HospitalUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Aug 2022 (estimated)
- First posted
- 15 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Routine treatment | Other | Drug: LevosimendanRoutine 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of ARDS; joined this study with informed consents
Key exclusion criteria (1 listed)
- neurological and muscle diseases; Chronic severe liver and kidney failure; advanced malignant tumor; Primary left ventricular insufficiency;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevosimendanGeneral 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. | Drug | Routine treatment |
Primary outcome
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
SOFA score
Time frame: Admission for 7 days
The total score is 0~48 points. The higher the score, the more serious the disease
2 secondary outcomes
Mechanical ventilation time
Time frame: From admission to 30 days
mecical expense
Time frame: From admission to 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
- Results publication: PubMed 26468714Wang 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.
- Results publication: PubMed 27705084Gordon 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Feng yongwen, master study chair
Shenzhen Second People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levosimendan in people with ARDS, Human, run by Shenzhen Second People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meng xinke, master (13751017051, mengxinke_2006@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
APACHE II score (time frame: Admission for 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04020003, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2019.