Respiratory Distress Syndrome, AdultNCT02759770
Risk Factors and Prediction Score of ARDS After Cardiac Surgery
An observational study of Respiratory Distress Syndrome, Adult and Thoracic Surgery, run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
Acute respiratory distress syndrome following cardiac surgery severely affects the prognosis of patients; the mortality is up to 40%. Although experience many years of research and exploration, the effective methods for the treatment of acute respiratory distress syndrome is still relatively limited at present… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Respiratory Distress Syndrome, Adult, Thoracic Surgery, Risk Factors
- How many people
- 1,333 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2017to 30 Sep 2017
- Phase
- Observational
- 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
Study population: Patients of cardiac surgery in Beijing Anzhen hospital
Who may be able to join
- Retrospective group: cardiac surgery patients accepted from Jan 2013 to Dec 2015
- Prospective group: cardiac surgery patients accepted from 2017 January to December
Who cannot join
- refused to participate in the study
- age less than 18 years old
- before operation performed mechanical ventilation
- before operation underwent IABP treatment
- before operation continuous renal replacement therapy
- before operation undergoing in vitro membrane oxygenator treatment
Show all 10Show fewer
- before operation has the pulmonary imaging showed bilateral pulmonary diffuse exudation of interstitial pneumonia, pulmonary infection or respiratory failure
- the major trauma, sepsis, aspiration, shock, acute heart failure
- before operation diagnosed as malignant tumor
- Incomplete data.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Respiratory and Critical Care Medicine, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Diseases
Beijing, Beijing Municipality, 100029
About this study
Acute respiratory distress syndrome following cardiac surgery severely affects the prognosis of patients; the mortality is up to 40%. Although experience many years of research and exploration, the effective methods for the treatment of acute respiratory distress syndrome is still relatively limited at present, including lung protective mechanical ventilation respiratory support, fluid management, glucocorticoid and other integrated organ function maintenance measures. It is currently the research of acute respiratory distress syndrome aims at the early discovery and takes effective measures to prevent its occurrence, hoping to improve the prognosis of patients. According to risk factors is established through the analysis of lung injury score early warning system, the early identification of acute respiratory distress syndrome patients at high risk, before the occurrence of acute respiratory distress syndrome take corresponding preventive measures can effectively reduce the incidence rate and mortality. So far, domestic and foreign research on the establishment of acute respiratory distress syndrome scoring early warning system is less. Cardiac surgery has significant characteristics, type of operation, location, operation, intraoperative blood transfusion and oxygenation, postoperative factors, are likely to be the factors of acute respiratory distress syndrome. As far as investigators know, so far there are few specialized for acute respiratory distress syndrome predicting lung injury after cardiac surgery. This study will be completed after the implementation of individualized dynamic lung injury score evaluation of cardiac surgery patients, identification of high-risk acute respiratory distress syndrome patients, to assist clinicians in early decision, take preventive measures. This study will improve the prognosis of acute respiratory distress syndrome patients after cardiac surgery; it is of great significance to improve the level of intensive care after cardiac surgery.
- Being tested
- no intervention
- 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.
no interventionOther
This is a clinical observational study, no intervention was included.
| Study group | Role | What they receive |
|---|---|---|
| ARDS | ARDS patients after cardiac surgery Receives: Other: no intervention | |
| non-ARDS | non-ARDS patients after cardiac surgery Receives: Other: no intervention | |
| propective group | patients of cardiac surgery including ARDS and non-ARDS patients Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital during Jan 2013 to Dec 2015.
Measured: up to 12months
The number of patients of cardiac surgery in Anzhen hospital during Jan 2013 to Dec 2015.
Measured: up to 12months
The number of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital during Jan 2017 to Dec 2017.
Measured: up to 12months
The number of patients of cardiac surgery in Anzhen hospital during Jan 2017 to Dec 2017.
Measured: up to 12months
The number of diabetic patients in ARDS group.
Measured: up to 1 month
The number of diabetic patients in non-ARDS group.
Measured: up to 1 month
The number of chronic obstructive pulmonary disease patients in ARDS group.
Measured: up to 1 month
The number of chronic obstructive pulmonary disease patients in non-ARDS group.
Measured: up to 1 month
The type of operation in ARDS group.
Measured: up to 1 month
The type of operation in non-ARDS group.
Measured: up to 1 month
The body mass index in ARDS group.
Measured: up to 1 month
The body mass index in non-ARDS group.
Measured: up to 1 month
The heart function in ARDS group before operation.
Measured: up to 1 month
The heart function in non-ARDS group before operation.
Measured: up to 1 month
The oxygenation in ARDS group before operation.
Measured: up to 1 month
The oxygenation in non-ARDS group before operation.
Measured: up to 1 month
The drug taken by patients in ARDS group.
Measured: up to 1 month
The drug taken by patients in non-ARDS group.
Measured: up to 1 month
The nutrition situation of patients in ARDS group.
Measured: up to 1 month
The nutrition situation of patients in non-ARDS group.
Measured: up to 1 month
The process of operation in ARDS group.
Measured: up to 1 month
The process of operation in non-ARDS group.
Measured: up to 1 month
The blood transfusion of patients during operation in ARDS group.
Measured: up to 1 month
The blood transfusion of patients during operation in non-ARDS group.
Measured: up to 1 month
The oxygenation of patients during operation in ARDS group.
Measured: up to 1 month
The oxygenation of patients during operation in non-ARDS group.
Measured: up to 1 month
The drug taken by patients after operation in ARDS group.
Measured: up to 1 month
The drug taken by patients after operation in non-ARDS group.
Measured: up to 1 month
The oxygenation of patients after operation in ARDS group.
Measured: up to 1 month
The oxygenation of patients after operation in non-ARDS group.
Measured: up to 1 month
The situation of mechanical ventilation of patients after operation in ARDS group.
Measured: up to 1 month
The situation of mechanical ventilation of patients after operation in non-ARDS group.
Measured: up to 1 month
Secondary outcomes (2)
The mortality of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital .
Measured: up to 1months
The morbidity of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital .
Measured: up to 1months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2016 (estimated)
- Study start1 Jul 2017
- Primary completion30 Sep 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress Syndrome, AdultStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 1,333 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guangfa Zhu, Beijing Anzhen Hospital
- Investigators
- Guangfa Zhu, Study chair, Department of Respiratory and Critical Care Medicine, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02759770
- Sponsor's protocol ID
- Shoufa-2016-2-1052
- Status last verified
- Dec 2019
- First submitted
- 25 Apr 2016
- Last updated
- 1 Feb 2021
- Results posted
- No
Publications
Kogan A, Preisman S, Levin S, Raanani E, Sternik L. Adult respiratory distress syndrome following cardiac surgery. J Card Surg. 2014 Jan;29(1):41-6. doi: 10.1111/jocs.12264. Epub 2013 Dec 3.
PubMed 24299028Berg KS, Stenseth R, Pleym H, Wahba A, Videm V. Mortality risk prediction in cardiac surgery: comparing a novel model with the EuroSCORE. Acta Anaesthesiol Scand. 2011 Mar;55(3):313-21. doi: 10.1111/j.1399-6576.2010.02393.x.
PubMed 21288212Forel JM, Voillet F, Pulina D, Gacouin A, Perrin G, Barrau K, Jaber S, Arnal JM, Fathallah M, Auquier P, Roch A, Azoulay E, Papazian L. Ventilator-associated pneumonia and ICU mortality in severe ARDS patients ventilated according to a lung-protective strategy. Crit Care. 2012 Dec 12;16(2):R65. doi: 10.1186/cc11312.
PubMed 22524447Grissom CK, Hirshberg EL, Dickerson JB, Brown SM, Lanspa MJ, Liu KD, Schoenfeld D, Tidswell M, Hite RD, Rock P, Miller RR 3rd, Morris AH; National Heart Lung and Blood Institute Acute Respiratory Distress Syndrome Clinical Trials Network. Fluid management with a simplified conservative protocol for the acute respiratory distress syndrome*. Crit Care Med. 2015 Feb;43(2):288-95. doi: 10.1097/CCM.0000000000000715.
PubMed 25599463Festic E, Kor DJ, Gajic O. Prevention of acute respiratory distress syndrome. Curr Opin Crit Care. 2015 Feb;21(1):82-90. doi: 10.1097/MCC.0000000000000174.
PubMed 25501020Rubenfeld GD. Who cares about preventing acute respiratory distress syndrome? Am J Respir Crit Care Med. 2015 Feb 1;191(3):255-60. doi: 10.1164/rccm.201408-1574CP.
PubMed 25478722Beitler JR, Schoenfeld DA, Thompson BT. Preventing ARDS: progress, promise, and pitfalls. Chest. 2014 Oct;146(4):1102-1113. doi: 10.1378/chest.14-0555.
PubMed 25288000ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.
PubMed 22797452Milot J, Perron J, Lacasse Y, Letourneau L, Cartier PC, Maltais F. Incidence and predictors of ARDS after cardiac surgery. Chest. 2001 Mar;119(3):884-8. doi: 10.1378/chest.119.3.884.
PubMed 11243972Michalopoulos A, Prapas S, Falagas ME. The incidence of adult respiratory distress syndrome in patients undergoing off-pump coronary artery bypass grafting surgery. Eur J Anaesthesiol. 2006 Jan;23(1):80. doi: 10.1017/S0265021505211821. No abstract available.
PubMed 16390572Vakili M, Shirani S, Paknejad O, Yousefshahi F. Acute Respiratory Distress Syndrome diagnosis after coronary artery bypass: comparison between diagnostic criteria and clinical picture. Acta Med Iran. 2015;53(1):51-6.
PubMed 25597606Kor DJ, Lingineni RK, Gajic O, Park PK, Blum JM, Hou PC, Hoth JJ, Anderson HL 3rd, Bajwa EK, Bartz RR, Adesanya A, Festic E, Gong MN, Carter RE, Talmor DS. Predicting risk of postoperative lung injury in high-risk surgical patients: a multicenter cohort study. Anesthesiology. 2014 May;120(5):1168-81. doi: 10.1097/ALN.0000000000000216.
PubMed 24755786
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors and Prediction Score of ARDS After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02759770
- Acronym / sponsor ID
- Shoufa-2016-2-1052
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,333 participants (actual)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 3 May 2016 (estimated)
- 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.
Acute respiratory distress syndrome following cardiac surgery severely affects the prognosis of patients; the mortality is up to 40%. Although experience many years of research and exploration, the effective methods for the treatment of acute respiratory distress syndrome is still relatively limited at present, including lung protective mechanical ventilation respiratory support, fluid management, glucocorticoid and other integrated organ function maintenance measures. It is currently the research of acute respiratory distress syndrome aims at the early discovery and takes effective measures to prevent its occurrence, hoping to improve the prognosis of patients. According to risk factors is established through the analysis of lung injury score early warning system, the early identification of acute respiratory distress syndrome patients at high risk, before the occurrence of acute respiratory distress syndrome take corresponding preventive measures can effectively reduce the incidence rate and mortality. So far, domestic and foreign research on the establishment of acute respiratory distress syndrome scoring early warning system is less. Cardiac surgery has significant characteristics, type of operation, location, operation, intraoperative blood transfusion and oxygenation, postoperative factors, are likely to be the factors of acute respiratory distress syndrome. As far as investigators know, so far there are few specialized for acute respiratory distress syndrome predicting lung injury after cardiac surgery. This study will be completed after the implementation of individualized dynamic lung injury score evaluation of cardiac surgery patients, identification of high-risk acute respiratory distress syndrome patients, to assist clinicians in early decision, take preventive measures. This study will improve the prognosis of acute respiratory distress syndrome patients after cardiac surgery; it is of great significance to improve the level of intensive care after cardiac surgery.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ARDS | – | Other: no interventionARDS patients after cardiac surgery |
| non-ARDS | – | Other: no interventionnon-ARDS patients after cardiac surgery |
| propective group | – | Other: no interventionpatients of cardiac surgery including ARDS and non-ARDS patients |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients of cardiac surgery in Beijing Anzhen hospital
Key inclusion criteria (2 listed)
- Retrospective group: cardiac surgery patients accepted from Jan 2013 to Dec 2015
- Prospective group: cardiac surgery patients accepted from 2017 January to December
Key exclusion criteria (10 listed)
- refused to participate in the study
- age less than 18 years old
- before operation performed mechanical ventilation
- before operation underwent IABP treatment
- before operation continuous renal replacement therapy
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 |
|---|---|---|
| no interventionThis is a clinical observational study, no intervention was included. | Other | ARDS, non-ARDS, propective group |
Primary outcome
The number of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital during Jan 2013 to Dec 2015.
Time frame: up to 12months
The number of patients of cardiac surgery in Anzhen hospital during Jan 2013 to Dec 2015.
Time frame: up to 12months
The number of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital during Jan 2017 to Dec 2017.
Time frame: up to 12months
The number of patients of cardiac surgery in Anzhen hospital during Jan 2017 to Dec 2017.
Time frame: up to 12months
The number of diabetic patients in ARDS group.
Time frame: up to 1 month
The number of diabetic patients in non-ARDS group.
Time frame: up to 1 month
The number of chronic obstructive pulmonary disease patients in ARDS group.
Time frame: up to 1 month
The number of chronic obstructive pulmonary disease patients in non-ARDS group.
Time frame: up to 1 month
The type of operation in ARDS group.
Time frame: up to 1 month
The type of operation in non-ARDS group.
Time frame: up to 1 month
The body mass index in ARDS group.
Time frame: up to 1 month
The body mass index in non-ARDS group.
Time frame: up to 1 month
The heart function in ARDS group before operation.
Time frame: up to 1 month
The heart function in non-ARDS group before operation.
Time frame: up to 1 month
The oxygenation in ARDS group before operation.
Time frame: up to 1 month
The oxygenation in non-ARDS group before operation.
Time frame: up to 1 month
The drug taken by patients in ARDS group.
Time frame: up to 1 month
The drug taken by patients in non-ARDS group.
Time frame: up to 1 month
The nutrition situation of patients in ARDS group.
Time frame: up to 1 month
The nutrition situation of patients in non-ARDS group.
Time frame: up to 1 month
The process of operation in ARDS group.
Time frame: up to 1 month
The process of operation in non-ARDS group.
Time frame: up to 1 month
The blood transfusion of patients during operation in ARDS group.
Time frame: up to 1 month
The blood transfusion of patients during operation in non-ARDS group.
Time frame: up to 1 month
The oxygenation of patients during operation in ARDS group.
Time frame: up to 1 month
The oxygenation of patients during operation in non-ARDS group.
Time frame: up to 1 month
The drug taken by patients after operation in ARDS group.
Time frame: up to 1 month
The drug taken by patients after operation in non-ARDS group.
Time frame: up to 1 month
The oxygenation of patients after operation in ARDS group.
Time frame: up to 1 month
The oxygenation of patients after operation in non-ARDS group.
Time frame: up to 1 month
The situation of mechanical ventilation of patients after operation in ARDS group.
Time frame: up to 1 month
The situation of mechanical ventilation of patients after operation in non-ARDS group.
Time frame: up to 1 month
2 secondary outcomes
The mortality of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital .
Time frame: up to 1months
The morbidity of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital .
Time frame: up to 1months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
- Background: PubMed 24299028Kogan A, Preisman S, Levin S, Raanani E, Sternik L. Adult respiratory distress syndrome following cardiac surgery. J Card Surg. 2014 Jan;29(1):41-6. doi: 10.1111/jocs.12264. Epub 2013 Dec 3.
- Background: PubMed 21288212Berg KS, Stenseth R, Pleym H, Wahba A, Videm V. Mortality risk prediction in cardiac surgery: comparing a novel model with the EuroSCORE. Acta Anaesthesiol Scand. 2011 Mar;55(3):313-21. doi: 10.1111/j.1399-6576.2010.02393.x.
- Background: PubMed 22524447Forel JM, Voillet F, Pulina D, Gacouin A, Perrin G, Barrau K, Jaber S, Arnal JM, Fathallah M, Auquier P, Roch A, Azoulay E, Papazian L. Ventilator-associated pneumonia and ICU mortality in severe ARDS patients ventilated according to a lung-protective strategy. Crit Care. 2012 Dec 12;16(2):R65. doi: 10.1186/cc11312.
- Background: PubMed 25599463Grissom CK, Hirshberg EL, Dickerson JB, Brown SM, Lanspa MJ, Liu KD, Schoenfeld D, Tidswell M, Hite RD, Rock P, Miller RR 3rd, Morris AH; National Heart Lung and Blood Institute Acute Respiratory Distress Syndrome Clinical Trials Network. Fluid management with a simplified conservative protocol for the acute respiratory distress syndrome*. Crit Care Med. 2015 Feb;43(2):288-95. doi: 10.1097/CCM.0000000000000715.
- Background: PubMed 25501020Festic E, Kor DJ, Gajic O. Prevention of acute respiratory distress syndrome. Curr Opin Crit Care. 2015 Feb;21(1):82-90. doi: 10.1097/MCC.0000000000000174.
- Background: PubMed 25478722Rubenfeld GD. Who cares about preventing acute respiratory distress syndrome? Am J Respir Crit Care Med. 2015 Feb 1;191(3):255-60. doi: 10.1164/rccm.201408-1574CP.
- Background: PubMed 25288000Beitler JR, Schoenfeld DA, Thompson BT. Preventing ARDS: progress, promise, and pitfalls. Chest. 2014 Oct;146(4):1102-1113. doi: 10.1378/chest.14-0555.
- Background: PubMed 22797452ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.
- Background: PubMed 11243972Milot J, Perron J, Lacasse Y, Letourneau L, Cartier PC, Maltais F. Incidence and predictors of ARDS after cardiac surgery. Chest. 2001 Mar;119(3):884-8. doi: 10.1378/chest.119.3.884.
- Background: PubMed 16390572Michalopoulos A, Prapas S, Falagas ME. The incidence of adult respiratory distress syndrome in patients undergoing off-pump coronary artery bypass grafting surgery. Eur J Anaesthesiol. 2006 Jan;23(1):80. doi: 10.1017/S0265021505211821. No abstract available.
- Background: PubMed 25597606Vakili M, Shirani S, Paknejad O, Yousefshahi F. Acute Respiratory Distress Syndrome diagnosis after coronary artery bypass: comparison between diagnostic criteria and clinical picture. Acta Med Iran. 2015;53(1):51-6.
- Background: PubMed 24755786Kor DJ, Lingineni RK, Gajic O, Park PK, Blum JM, Hou PC, Hoth JJ, Anderson HL 3rd, Bajwa EK, Bartz RR, Adesanya A, Festic E, Gong MN, Carter RE, Talmor DS. Predicting risk of postoperative lung injury in high-risk surgical patients: a multicenter cohort study. Anesthesiology. 2014 May;120(5):1168-81. doi: 10.1097/ALN.0000000000000216.
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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.
Guangfa Zhu study chair
Department of Respiratory and Critical Care Medicine, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Distress Syndrome, Adult and Thoracic Surgery, run by Beijing Anzhen 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 2 inclusion and 10 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: finished, as of the sponsor's last update on 1 Feb 2021. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital during Jan 2013 to Dec 2015. (time frame: up to 12months). The study lists 32 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 NCT02759770, which also lists 12 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 1 Feb 2021.