Acute Respiratory Distress Syndrome (ARDS)Phase 2IP steroidNCT01423864
Intrapleural Methylprednisolone Injection for Multiple Organ Failure With Acute Respiratory Distress Syndrome
A Phase 2 study testing conventional ECMO with intravenous steroid and solumedrol in people with Acute Respiratory Distress Syndrome (ARDS) and Multiple Organ Failure, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Acute respiratory distress syndrome (ARDS) in combination with multi-organ dysfunction syndrome (MODS) is a life-threatening condition, particularly when treatment modalities such as extracorporeal membrane oxygenation (ECMO) and catecholamine administration have failed to treat the severe condition. Read more about this study
- Who is it for?
- Ages 16 to 87 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome (ARDS), Multiple Organ Failure
- What is being tested?
- conventional ECMO with intravenous steroid and solumedrol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2005to Jun 2009
- Phase
- Phase 2
- 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 16 to 87 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All of the patients had failure of at least 2 organs acquiring arteriovenous or venovenous ECMO support
- All of the patients met the criteria as below:
- blood gas parameters of PaO2/FiO2 < 100
- bilateral pulmonary infiltration on chest radiographic images
- 100% oxygen demand in case of ventilation and ECMO flow
- hemodynamic instability requiring high catecholamine infusion
Show all 11Show fewer
- All the patients had scoring system, which were calculated by the physician within 24 h of admission of the patients into the hospital.
- sequential organ failure assessment score (SOFA) ≥ 10
- Acute Physiology and Chronic Health Evaluation II (APACHE II) score ≥ 20
- inotropic score ≥ 10
- multiple organ dysfunction (MOD) score ≥ 10
Who cannot join
- uncontrollable underlying disease
- life expectancy of less than 24 h
- immunosuppression
- neutrophil count of less than 0.3 × 109/L
- brainstem death
- history of long-term corticosteroid use during the past 6 months.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Surgery, National Taiwan University Hospital
7, Chung-Shan S. Rd, Taipei 10002, Taiwan., Taiwan, 10002
About this study
Official title: Retrospective Study of Intrapleural Methylprednisolone Injection for Multiple Organ Failure With Acute Respiratory Distress Syndrome
Acute respiratory distress syndrome (ARDS) in combination with multi-organ dysfunction syndrome (MODS) is a life-threatening condition, particularly when treatment modalities such as extracorporeal membrane oxygenation (ECMO) and catecholamine administration have failed to treat the severe condition. In this study, the investigators report patients who responded to intrapleural steroid instillation (IPSI) while being unresponsive to conventional treatment (use of intravenous steroids, nitric oxide inhalation, high-frequency oscillatory ventilation, or ECMO) for treatment of critical illnesses such as ARDS in combination with MODS.
Read the detailed description
Acute respiratory distress syndrome (ARDS) with multi-organ dysfunction syndrome (MODS) are common debilitating postoperative complications, which also result from shock and trauma. However, despite the use of ECMO, mortality rate among hypoxia patients remains high in such critical care conditions. Corticosteroid therapy inhibits ongoing inflammation and abnormal deposition of collagen. However, intravenous administration of corticosteroids may be harmful because it may increase the risk of associated neuromyopathy in critically ill patients. Although intrapleural instillation of steroids has been employed in several pleural diseases,little is known about the therapeutic effects of this treatment method on ARDS in combination with MODS. Therefore, in the present pilot study, the investigators hypothesized that timely initiation of intrapleural steroid instillation (IPSI) will positively influence ventilation in and survival of patients with ARDS in combination with MODS.
The investigators conducted a retrospective study on ninety-two of the 467 ECMOs performed between 2005 and 2009 were on ARDS patients. Analyses of gas exchange, tidal volumes, airway pressures, respiratory frequency, and vasopressor and sedation requirements were performed before and after intervention.
The indication for IPSI was unresponsive severe ARDS in combination with MODS when all the other treatment modalities such as intravenous steroid administration, nitric oxide inhalation, high-frequency oscillatory ventilation, or ECMO performed within 2 days were unsuccessful.
An experienced team performed thoracic catheterization of the patients under ultrasound evaluation. Patients with severe pleural adhesion were considered unsuitable for IPSI. The dosage of the intrapleural steroid was determined on the basis of the chest radiographic examination, inspired oxygen concentration, and positive end-expiratory pressure (PEEP) of the ventilator.
- Being tested
- conventional ECMO with intravenous steroid, solumedrol
- Keywords
- Acute Respiratory Distress Syndrome, Multi-organ Dysfunction Syndrome, Extracorporeal Membrane Oxygenation
- Medical subject headings
- Respiratory Distress Syndrome, Multiple Organ Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional ECMO with intravenous steroidDrug
Also called Solu-Cortef
refractory acute respiratory distress syndrome and multi-organ dysfunction syndrome treated with intravenous steroid, Solu-Cortef 50mg q6h taper down when hemodynamic stable
solumedrolDrug
Initially, intrapleural steroid administration was performed using 40 mg solumedrol q6h (for both the pleural cavities). If chest radiography showed an improvement in consolidation, i.e., 0.8 > FiO2 ≥ 0.5 and 5 ≤ PEEP ≤ 10, the dosage of solumedrol was reduced to 40 mg q12h. When FiO2 was below 0.5 and the PEEP was below 10, the dosage of solumedrol was lowered to 40 mg qd for 3 days and then its administration was discontinued.
| Study group | Role | What they receive |
|---|---|---|
| conventional ECMO with intravenous steroid | Sham comparator | refractory acute respiratory distress syndrome and multi-organ dysfunction syndrome unresponsive to conventional extracorporeal membrane oxygenation Receives: Drug: conventional ECMO with intravenous steroid |
| Drug: intrapleural steroid instillation | Experimental | refractory acute respiratory distress syndrome and multi-organ dysfunction syndrome unresponsive to conventional extracorporeal membrane oxygenation Receives: Drug: solumedrol |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival until discharge from the hospital
Comparing the difference between two groups about the survival ratio of discharge from the hospital
Measured: 2005~2009 (up to 4 years)
Secondary outcomes (3)
Incidence of complications
complication of the interventional treatment will be followed for the duration of hospital stay
Measured: 12 weeks
the effects on tidal volumes
the therapeutic effects in the improvement of tidal volumes, followed for the duration of ventilator usage
Measured: up to 12 weeks
the therapeutic effects on oxygenation
the therapeutic effects in the improvement of oxygenation, followed for the duration of hospital stay
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2011 (estimated)
- Study startJun 2005
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress Syndrome (ARDS)Studies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pei-Ming Huang, MD, MS, Principal investigator, National Taiwan University Hospital and National Taiwan University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01423864
- Sponsor's protocol ID
- 200906014R
- Acronym
- IP steroid
- Status last verified
- Aug 2011
- First submitted
- 18 Aug 2011
- Last updated
- 26 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Zhang J, Wang W, Sun J, Li Q, Liu J, Zhu H, Chen T, Wang H, Yu S, Sun G, Chen W, Yi D. Gap junction channel modulates pulmonary vascular permeability through calcium in acute lung injury: an experimental study. Respiration. 2010;80(3):236-45. doi: 10.1159/000274384. Epub 2010 Jan 7.
PubMed 20090287Suchyta MR, Clemmer TP, Orme JF Jr, Morris AH, Elliott CG. Increased survival of ARDS patients with severe hypoxemia (ECMO criteria). Chest. 1991 Apr;99(4):951-5. doi: 10.1378/chest.99.4.951.
PubMed 2009801Biffl WL, Moore FA, Moore EE, Haenel JB, McIntyre RC Jr, Burch JM. Are corticosteroids salvage therapy for refractory acute respiratory distress syndrome? Am J Surg. 1995 Dec;170(6):591-5; discussion 595-6. doi: 10.1016/s0002-9610(99)80022-1.
PubMed 7492007Brunet F, Mira JP, Belghith M, Monchi M, Renaud B, Fierobe L, Hamy I, Dhainaut JF, Dall'ava-Santucci J. Extracorporeal carbon dioxide removal technique improves oxygenation without causing overinflation. Am J Respir Crit Care Med. 1994 Jun;149(6):1557-62. doi: 10.1164/ajrccm.149.6.8004313.
PubMed 8004313Wiener-Kronish JP, Broaddus VC. Interrelationship of pleural and pulmonary interstitial liquid. Annu Rev Physiol. 1993;55:209-26. doi: 10.1146/annurev.ph.55.030193.001233.
PubMed 8466174Lewandowski K, Rossaint R, Pappert D, Gerlach H, Slama KJ, Weidemann H, Frey DJ, Hoffmann O, Keske U, Falke KJ. High survival rate in 122 ARDS patients managed according to a clinical algorithm including extracorporeal membrane oxygenation. Intensive Care Med. 1997 Aug;23(8):819-35. doi: 10.1007/s001340050418.
PubMed 9310799Dagenais A, Denis C, Vives MF, Girouard S, Masse C, Nguyen T, Yamagata T, Grygorczyk C, Kothary R, Berthiaume Y. Modulation of alpha-ENaC and alpha1-Na+-K+-ATPase by cAMP and dexamethasone in alveolar epithelial cells. Am J Physiol Lung Cell Mol Physiol. 2001 Jul;281(1):L217-30. doi: 10.1152/ajplung.2001.281.1.L217.
PubMed 11404265Annane D, Sebille V, Charpentier C, Bollaert PE, Francois B, Korach JM, Capellier G, Cohen Y, Azoulay E, Troche G, Chaumet-Riffaud P, Bellissant E. Effect of treatment with low doses of hydrocortisone and fludrocortisone on mortality in patients with septic shock. JAMA. 2002 Aug 21;288(7):862-71. doi: 10.1001/jama.288.7.862.
PubMed 12186604North SA, Au HJ, Halls SB, Tkachuk L, Mackey JR. A randomized, phase III, double-blind, placebo-controlled trial of intrapleural instillation of methylprednisolone acetate in the management of malignant pleural effusion. Chest. 2003 Mar;123(3):822-7. doi: 10.1378/chest.123.3.822.
PubMed 12628884Gerlach H, Keh D, Semmerow A, Busch T, Lewandowski K, Pappert DM, Rossaint R, Falke KJ. Dose-response characteristics during long-term inhalation of nitric oxide in patients with severe acute respiratory distress syndrome: a prospective, randomized, controlled study. Am J Respir Crit Care Med. 2003 Apr 1;167(7):1008-15. doi: 10.1164/rccm.2108121.
PubMed 12663340Broccard AF. Prone position in ARDS: are we looking at a half-empty or half-full glass? Chest. 2003 May;123(5):1334-6. doi: 10.1378/chest.123.5.1334. No abstract available.
PubMed 12740242Dunser M, Hasibeder W, Rieger M, Mayr AJ. Successful therapy of severe pneumonia-associated ARDS after pneumonectomy with ECMO and steroids. Ann Thorac Surg. 2004 Jul;78(1):335-7. doi: 10.1016/S0003-4975(03)01264-5.
PubMed 15223462Tomiyama H, Takara I, Tokumine J, Sugahara K. [Sivelestat sodium hydrate was effective for ARDS in a patient suffering from chronic rheumatoid arthritis with acute exacerbation after failing to respond to high dose steroid pulse therapy]. Masui. 2004 Sep;53(9):1042-6. Japanese.
PubMed 15500109Zemans RL, Matthay MA. Bench-to-bedside review: the role of the alveolar epithelium in the resolution of pulmonary edema in acute lung injury. Crit Care. 2004 Dec;8(6):469-77. doi: 10.1186/cc2906. Epub 2004 Jun 30.
PubMed 15566618Shinozaki M. [Respiratory and cadiovascular management of septic ALI-ARDS and shock]. Nihon Rinsho. 2004 Dec;62(12):2301-7. Japanese.
PubMed 15597800
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of Intrapleural Methylprednisolone Injection for Multiple Organ Failure With Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT01423864
- Acronym / sponsor ID
- IP steroid / 200906014R
- Keywords
- Acute Respiratory Distress Syndrome, Multi-organ Dysfunction Syndrome, Extracorporeal Membrane Oxygenation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 26 Aug 2011 (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 (ARDS) in combination with multi-organ dysfunction syndrome (MODS) is a life-threatening condition, particularly when treatment modalities such as extracorporeal membrane oxygenation (ECMO) and catecholamine administration have failed to treat the severe condition. In this study, the investigators report patients who responded to intrapleural steroid instillation (IPSI) while being unresponsive to conventional treatment (use of intravenous steroids, nitric oxide inhalation, high-frequency oscillatory ventilation, or ECMO) for treatment of critical illnesses such as ARDS in combination with MODS.
Detailed description
Acute respiratory distress syndrome (ARDS) with multi-organ dysfunction syndrome (MODS) are common debilitating postoperative complications, which also result from shock and trauma. However, despite the use of ECMO, mortality rate among hypoxia patients remains high in such critical care conditions. Corticosteroid therapy inhibits ongoing inflammation and abnormal deposition of collagen. However, intravenous administration of corticosteroids may be harmful because it may increase the risk of associated neuromyopathy in critically ill patients. Although intrapleural instillation of steroids has been employed in several pleural diseases,little is known about the therapeutic effects of this treatment method on ARDS in combination with MODS. Therefore, in the present pilot study, the investigators hypothesized that timely initiation of intrapleural steroid instillation (IPSI) will positively influence ventilation in and survival of patients with ARDS in combination with MODS.
The investigators conducted a retrospective study on ninety-two of the 467 ECMOs performed between 2005 and 2009 were on ARDS patients. Analyses of gas exchange, tidal volumes, airway pressures, respiratory frequency, and vasopressor and sedation requirements were performed before and after intervention.
The indication for IPSI was unresponsive severe ARDS in combination with MODS when all the other treatment modalities such as intravenous steroid administration, nitric oxide inhalation, high-frequency oscillatory ventilation, or ECMO performed within 2 days were unsuccessful.
An experienced team performed thoracic catheterization of the patients under ultrasound evaluation. Patients with severe pleural adhesion were considered unsuitable for IPSI. The dosage of the intrapleural steroid was determined on the basis of the chest radiographic examination, inspired oxygen concentration, and positive end-expiratory pressure (PEEP) of the ventilator.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional ECMO with intravenous steroid | Sham comparator | Drug: conventional ECMO with intravenous steroidrefractory acute respiratory distress syndrome and multi-organ dysfunction syndrome unresponsive to conventional extracorporeal membrane oxygenation |
| Drug: intrapleural steroid instillation | Experimental | Drug: solumedrolrefractory acute respiratory distress syndrome and multi-organ dysfunction syndrome unresponsive to conventional extracorporeal membrane oxygenation |
Who may qualify
- Ages
- 16 to 87 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- All of the patients had failure of at least 2 organs acquiring arteriovenous or venovenous ECMO support
- All of the patients met the criteria as below:
Key exclusion criteria (6 listed)
- uncontrollable underlying disease
- life expectancy of less than 24 h
- immunosuppression
- neutrophil count of less than 0.3 × 109/L
- brainstem death
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 |
|---|---|---|
| conventional ECMO with intravenous steroidAlso: Solu-Cortefrefractory acute respiratory distress syndrome and multi-organ dysfunction syndrome treated with intravenous steroid, Solu-Cortef 50mg q6h taper down when hemodynamic stable | Drug | conventional ECMO with intravenous steroid |
| solumedrolInitially, intrapleural steroid administration was performed using 40 mg solumedrol q6h (for both the pleural cavities). If chest radiography showed an improvement in consolidation, i.e., 0.8 > FiO2 ≥ 0.5 and 5 ≤ PEEP ≤ 10, the dosage of solumedrol was reduced to 40 mg q12h. When FiO2 was below 0.5 and the PEEP was below 10, the dosage of solumedrol was lowered to 40 mg qd for 3 days and then its administration was discontinued. | Drug | Drug: intrapleural steroid instillation |
Primary outcome
survival until discharge from the hospital
Time frame: 2005~2009 (up to 4 years)
Comparing the difference between two groups about the survival ratio of discharge from the hospital
3 secondary outcomes
Incidence of complications
Time frame: 12 weeks
the effects on tidal volumes
Time frame: up to 12 weeks
the therapeutic effects on oxygenation
Time frame: up to 12 weeks
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 26 Aug 2011.
- Background: PubMed 20090287Zhang J, Wang W, Sun J, Li Q, Liu J, Zhu H, Chen T, Wang H, Yu S, Sun G, Chen W, Yi D. Gap junction channel modulates pulmonary vascular permeability through calcium in acute lung injury: an experimental study. Respiration. 2010;80(3):236-45. doi: 10.1159/000274384. Epub 2010 Jan 7.
- Background: PubMed 2009801Suchyta MR, Clemmer TP, Orme JF Jr, Morris AH, Elliott CG. Increased survival of ARDS patients with severe hypoxemia (ECMO criteria). Chest. 1991 Apr;99(4):951-5. doi: 10.1378/chest.99.4.951.
- Background: PubMed 7492007Biffl WL, Moore FA, Moore EE, Haenel JB, McIntyre RC Jr, Burch JM. Are corticosteroids salvage therapy for refractory acute respiratory distress syndrome? Am J Surg. 1995 Dec;170(6):591-5; discussion 595-6. doi: 10.1016/s0002-9610(99)80022-1.
- Background: PubMed 8004313Brunet F, Mira JP, Belghith M, Monchi M, Renaud B, Fierobe L, Hamy I, Dhainaut JF, Dall'ava-Santucci J. Extracorporeal carbon dioxide removal technique improves oxygenation without causing overinflation. Am J Respir Crit Care Med. 1994 Jun;149(6):1557-62. doi: 10.1164/ajrccm.149.6.8004313.
- Background: PubMed 8466174Wiener-Kronish JP, Broaddus VC. Interrelationship of pleural and pulmonary interstitial liquid. Annu Rev Physiol. 1993;55:209-26. doi: 10.1146/annurev.ph.55.030193.001233.
- Background: PubMed 9310799Lewandowski K, Rossaint R, Pappert D, Gerlach H, Slama KJ, Weidemann H, Frey DJ, Hoffmann O, Keske U, Falke KJ. High survival rate in 122 ARDS patients managed according to a clinical algorithm including extracorporeal membrane oxygenation. Intensive Care Med. 1997 Aug;23(8):819-35. doi: 10.1007/s001340050418.
- Background: PubMed 11404265Dagenais A, Denis C, Vives MF, Girouard S, Masse C, Nguyen T, Yamagata T, Grygorczyk C, Kothary R, Berthiaume Y. Modulation of alpha-ENaC and alpha1-Na+-K+-ATPase by cAMP and dexamethasone in alveolar epithelial cells. Am J Physiol Lung Cell Mol Physiol. 2001 Jul;281(1):L217-30. doi: 10.1152/ajplung.2001.281.1.L217.
- Background: PubMed 12186604Annane D, Sebille V, Charpentier C, Bollaert PE, Francois B, Korach JM, Capellier G, Cohen Y, Azoulay E, Troche G, Chaumet-Riffaud P, Bellissant E. Effect of treatment with low doses of hydrocortisone and fludrocortisone on mortality in patients with septic shock. JAMA. 2002 Aug 21;288(7):862-71. doi: 10.1001/jama.288.7.862.
- Background: PubMed 12628884North SA, Au HJ, Halls SB, Tkachuk L, Mackey JR. A randomized, phase III, double-blind, placebo-controlled trial of intrapleural instillation of methylprednisolone acetate in the management of malignant pleural effusion. Chest. 2003 Mar;123(3):822-7. doi: 10.1378/chest.123.3.822.
- Background: PubMed 12663340Gerlach H, Keh D, Semmerow A, Busch T, Lewandowski K, Pappert DM, Rossaint R, Falke KJ. Dose-response characteristics during long-term inhalation of nitric oxide in patients with severe acute respiratory distress syndrome: a prospective, randomized, controlled study. Am J Respir Crit Care Med. 2003 Apr 1;167(7):1008-15. doi: 10.1164/rccm.2108121.
- Background: PubMed 12740242Broccard AF. Prone position in ARDS: are we looking at a half-empty or half-full glass? Chest. 2003 May;123(5):1334-6. doi: 10.1378/chest.123.5.1334. No abstract available.
- Background: PubMed 15223462Dunser M, Hasibeder W, Rieger M, Mayr AJ. Successful therapy of severe pneumonia-associated ARDS after pneumonectomy with ECMO and steroids. Ann Thorac Surg. 2004 Jul;78(1):335-7. doi: 10.1016/S0003-4975(03)01264-5.
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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.
Pei-Ming Huang, MD, MS principal investigator
National Taiwan University Hospital and National Taiwan University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing conventional ECMO with intravenous steroid and solumedrol in people with Acute Respiratory Distress Syndrome (ARDS) and Multiple Organ Failure, run by National Taiwan University Hospital at 1 site in Taiwan.
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 11 inclusion and 6 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 26 Aug 2011. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
survival until discharge from the hospital (time frame: 2005~2009 (up to 4 years)). 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 NCT01423864, which also lists 19 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 26 Aug 2011.