Severe Acute PancreatitisPCISLAMSNCT05508828
Percutaneous Continuous Irrigation Combined With Transgastric Necrosectomy usingLAMS in Treatment of SAP
An observational study of Severe Acute Pancreatitis and Pancreatic Necrosis, run by Chinese Medical Association at 1 site in China.
Trial summary
Severe acute pancreatitis (SAP) is the most severe form of acute pancreatitis (AP) and Infection of pancreatic necrosis (IPN) have shown to be one of the decisive factors defining the severity of illness. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Severe Acute Pancreatitis, Pancreatic Necrosis
- What is being tested?
- Percutaneous Continuous Irrigation assisted Vacuum Drainage Combined With Transgastric Necrosectomy
- Type of treatment
- Surgery or procedure
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 14 Aug 2022
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with SAP and IPN;SAP was diagnosed according to the revised Atlanta classification, which defined simultaneous persistent single or multiple organ failure >48h;IPN was considered when the following situations occur: persistent fever ≥38.5℃; increasing blood white blood cells (WBC), C-reactive protein (CRP) or procalcitonin; rapid deterioration of clinical deterioration; signs of gas was present in areas of necrosis. IPN is confirmed when the patient undergoes fine needle aspiration and the culture was positive.
Who may be able to join
- Diagnosed with SAP
- Concurrent IPN
Who cannot join
- Age <18 years or > 80 years
- Patients or family members disagreed with this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Percutaneous Continuous Irrigation Assisted Vacuum Drainage Combined With Transgastric Necrosectomy Using Lumen Apposing Metal Stents in Treatment of Severe Acute Pancreatitis
Severe acute pancreatitis (SAP) is the most severe form of acute pancreatitis (AP) and Infection of pancreatic necrosis (IPN) have shown to be one of the decisive factors defining the severity of illness.
Minimally invasive techniques including endoscopy, laparoscopy, retroperitoneal approaches, etc., have recently been widely used for debridement because the procedure can further reduces surgical stress and performed not require general anesthesia, thereby reducing complications. Studies have shown that endoscopic transgastric necrosectomy can significantly reduced the proinflammatory response, complications, and hospital stay. Despite these advantages, there are some limitations with this approach. First, transgastric necrosectomy should be performed as late (about 4 weeks) in the course of the disease as possible to allow necrosis to wrap, since early debridement may result in a higher patient fatality rate. However, patients with SAP are often in a severely ill state due to sepsis or MODS at an early stage, which causes them unable to adhere to necrotic tissue encapsulation by conservative treatment. Second, the ideal patient to select for this approach has necrosis confined in the vicinity of gastroduodenal location. Last, up to 27% of IPN patients require additional percutaneous catheter drainage (PCD) after undergoing endoscopic transluminal therapy. This may be explained by the fact that dissemination of necrosis, digestive enzymes and inflammatory mediators from the necrotic tissue lumen to other parts of the abdominal cavity during endoscopic procedures.
Read more
Percutaneous catheter drainage (PCD) has always been the principal treatment measure for patients with AP at early stage (< 4 weeks) or those with collections or necrosis extending into deeper anatomical planes. Irrigation through peripancreatic drainage placed after open laparotomy has been the standard treatment for patients with AP who had undergone surgical necrosectomy. However, this proactive approach has not been widely used in the setting of PCD.
To adequate drainage and removal of necrosis, an early percutaneous continuous irrigation assisted vacuum drainage in combination with subsequent endoscopic transgastric necrosectomy which has not been reported so far was applied in critically ill patients with SAP.
Read the detailed description
Severe Acute Pancreatitis (SAP) Treatment Protocol After admission, patients were given intravenous analgetics, omeprazole and somatostatin, and nasojejunal tubes were placed for EN. Once fever developed, broad-spectrum antibiotics were given empirically. If the patient was concomitant with shock, respiratory failure, and acute kidney injury, appropriate organ support was provided. Patients with biliary pancreatitis was given encoscopic retrograde cholangiopancreato graphy (ERCP) within 24 h after admission. When the patient was diagnosed with hyperlipidemic pancreatitis and plasma triglyceride ≥11.3 mmol/L, plasma exchange was administered immediately. All patients were given contrast enhanced CT within 48 hours after admission to identify the location and range of the necrosis and calculate the CT severity index (CISI).
Procedure All PCD and endoscopic procedures were performed under conscious sedation or local anesthesia. If the patient's condition progressively worsened, a multifunctional irrigation-assisted vacuum drainage tube was placed by the CT-guided Seldinger technique in each of the necrosis cavity. The tube was administered with continuous internal irrigation and vacuum drainage as described in below: (1) the end of the drainage tube (the adapter) was connected to a vacuum device that delivers a controlled negative pressure within the range of 8-10 kPa. (2) a large volume of 0.9% normal saline was infused into the necrosis cavity constantly (1500mL a day, 65mL an hour) through the durg entrance, allowing for continuous irrigation; (3) the inside drainage tube was flush by rapid manual injection of 50-100 mL 0.9% normal saline twice a day through the drug entrance and inject 20-50 mL of 0.9% normal saline daily through water entrance to prevent the tube from becoming blocked by necrosis, debris or omentum; (4) total irrigation and drainage volume were checked every 8 hours to keep the irrigation-drainage balanced. All tubes were checked daily and replaced when the tube was translocated or blocked. When the volume of irrigation exceeds the drainage 500 mL/day or if there were serious complications associated with the drainage tube, continuous irrigation and vacuum drainage should be stopped immediately and the tube was the traditional drainage was performed.
Approximately 4 weeks after disease onset or the formation of well-defined wall was confirmed by repeat CT scan, transgastric necrosectomy were performed by one or two experienced endoscopist under conscious sedation. Transgastric necrosectomy was repeated, mostly every three to five days, until all loosely adherent necrotic material were cleared and replaced by granulation tissue. In the course of the procedure, antibiotic administration was adjusted based on the results of the microbiological culture results. Subsequently, percutaneous irrigation was stopped and replace with simple drainage if the patient's condition continues to improved and the cavity confirmed by CT was resolution. If the drainage volume was less than 10 mL/day for 3 consecutive days, clamp the drainage tube and remove it finally.
- Conditions
- Severe Acute Pancreatitis, Pancreatic Necrosis
- Being tested
- Percutaneous Continuous Irrigation assisted Vacuum Drainage Combined With Transgastric Necrosectomy
- Medical subject headings
- Pancreatitis, Pancreatitis, Acute Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Continuous Irrigation assisted Vacuum Drainage Combined With Transgastric NecrosectomyProcedure or surgery
All patients with SAP were given contrast enhanced CT scan within 48 hours after admission to identify the location and range of the necrosis. If the patient's condition progressively worsened, a multifunctional irrigation-assisted vacuum drainage tube was placed by the CT-guided Seldinger technique in each of the necrosis cavity. Subsequently, transgastric necrosectomy were performed by one or two experienced endoscopist under conscious sedation. The procedure was repeated until all loosely adherent necrotic material were cleared and replaced by granulation tissue. Percutaneous irrigation was stopped and replace with simple drainage if the patient's condition continues to improved and the cavity confirmed by CT was resolution. If the drainage volume was less than 10 mL/day for 3 consecutive days, clamp the drainage tube and remove it finally.
| Study group | Role | What they receive |
|---|---|---|
| The study group | We retrospectively analysis of 8 consecutive patients with SAP and IPN. SAP was diagnosed with persistent organ failure >48h. IPN was considered when the following situations occur: ≥38.5℃; increasing WBC, CRP or procalcitonin; rapid clinical deterioration; signs of gas was present in areas of necrosis. Receives: Procedure: Percutaneous Continuous Irrigation assisted Vacuum Drainage Combined With Transgastric Necrosectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
28day-mortality
Measured: Day28 after enrollment
Secondary outcomes (2)
PCD
duration of PCD
Measured: From the first catheter placement to total catheter removal
endoscopic procedures
number of endoscopic procedures
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start1 Jan 2019
- Primary completion9 May 2022
- Study completion14 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Severe Acute PancreatitisStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Medical Association
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Wenkui Yu, Ph.D, Study chair, Study concept and study design
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05508828
- Sponsor's protocol ID
- DRUMPCILAMS
- Acronym
- PCISLAMS
- Status last verified
- Jan 2019
- First submitted
- 14 Aug 2022
- Last updated
- 19 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van Santvoort HC, Besselink MG, Bakker OJ, Hofker HS, Boermeester MA, Dejong CH, van Goor H, Schaapherder AF, van Eijck CH, Bollen TL, van Ramshorst B, Nieuwenhuijs VB, Timmer R, Lameris JS, Kruyt PM, Manusama ER, van der Harst E, van der Schelling GP, Karsten T, Hesselink EJ, van Laarhoven CJ, Rosman C, Bosscha K, de Wit RJ, Houdijk AP, van Leeuwen MS, Buskens E, Gooszen HG; Dutch Pancreatitis Study Group. A step-up approach or open necrosectomy for necrotizing pancreatitis. N Engl J Med. 2010 Apr 22;362(16):1491-502. doi: 10.1056/NEJMoa0908821.
PubMed 20410514Lee JK, Kwak KK, Park JK, Yoon WJ, Lee SH, Ryu JK, Kim YT, Yoon YB. The efficacy of nonsurgical treatment of infected pancreatic necrosis. Pancreas. 2007 May;34(4):399-404. doi: 10.1097/MPA.0b013e318043c0b1.
PubMed 17446837Ross A, Gluck M, Irani S, Hauptmann E, Fotoohi M, Siegal J, Robinson D, Crane R, Kozarek R. Combined endoscopic and percutaneous drainage of organized pancreatic necrosis. Gastrointest Endosc. 2010 Jan;71(1):79-84. doi: 10.1016/j.gie.2009.06.037. Epub 2009 Oct 27.
PubMed 19863956Sahar N, Kozarek R, Kanji ZS, Ross AS, Gluck M, Gan SI, Larsen M, Irani S. Do lumen-apposing metal stents (LAMS) improve treatment outcomes of walled-off pancreatic necrosis over plastic stents using dual-modality drainage? Endosc Int Open. 2017 Nov;5(11):E1052-E1059. doi: 10.1055/s-0043-111794. Epub 2017 Oct 26.
PubMed 29090245Jagielski M, Smoczynski M, Studniarek M, Adrych K. Endoscopic drainage combined with percutaneous drainage in treatment of walled-off pancreatic necrosis - a single-center experience. Prz Gastroenterol. 2018;13(2):137-142. doi: 10.5114/pg.2018.72604. Epub 2018 Jan 5.
PubMed 30002773Zhang B, Gao T, Wang Y, Zhu H, Liu S, Chen M, Yu W, Zhu Z. A novel mini-invasive step-up approach for the treatment of severe acute pancreatitis with extensive infected necrosis: A single center case series study. Medicine (Baltimore). 2023 Mar 17;102(11):e33288. doi: 10.1097/MD.0000000000033288.
PubMed 36930105
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Percutaneous Continuous Irrigation Assisted Vacuum Drainage Combined With Transgastric Necrosectomy Using Lumen Apposing Metal Stents in Treatment of Severe Acute Pancreatitis
- ClinicalTrials.gov ID
- NCT05508828
- Acronym / sponsor ID
- PCISLAMS / DRUMPCILAMS
- Conditions
- Severe Acute Pancreatitis, Pancreatic Necrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Chinese Medical AssociationResearch network
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 9 May 2022 (actual)
- Study completion
- 14 Aug 2022 (actual)
- First posted
- 19 Aug 2022 (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.
Severe acute pancreatitis (SAP) is the most severe form of acute pancreatitis (AP) and Infection of pancreatic necrosis (IPN) have shown to be one of the decisive factors defining the severity of illness.
Minimally invasive techniques including endoscopy, laparoscopy, retroperitoneal approaches, etc., have recently been widely used for debridement because the procedure can further reduces surgical stress and performed not require general anesthesia, thereby reducing complications. Studies have shown that endoscopic transgastric necrosectomy can significantly reduced the proinflammatory response, complications, and hospital stay. Despite these advantages, there are some limitations with this approach. First, transgastric necrosectomy should be performed as late (about 4 weeks) in the course of the disease as possible to allow necrosis to wrap, since early debridement may result in a higher patient fatality rate. However, patients with SAP are often in a severely ill state due to sepsis or MODS at an early stage, which causes them unable to adhere to necrotic tissue encapsulation by conservative treatment. Second, the ideal patient to select for this approach has necrosis confined in the vicinity of gastroduodenal location. Last, up to 27% of IPN patients require additional percutaneous catheter drainage (PCD) after undergoing endoscopic transluminal therapy. This may be explained by the fact that dissemination of necrosis, digestive enzymes and inflammatory mediators from the necrotic tissue lumen to other parts of the abdominal cavity during endoscopic procedures.
Percutaneous catheter drainage (PCD) has always been the principal treatment measure for patients with AP at early stage (< 4 weeks) or those with collections or necrosis extending into deeper anatomical planes. Irrigation through peripancreatic drainage placed after open laparotomy has been the standard treatment for patients with AP who had undergone surgical necrosectomy. However, this proactive approach has not been widely used in the setting of PCD.
To adequate drainage and removal of necrosis, an early percutaneous continuous irrigation assisted vacuum drainage in combination with subsequent endoscopic transgastric necrosectomy which has not been reported so far was applied in critically ill patients with SAP.
Detailed description
Severe Acute Pancreatitis (SAP) Treatment Protocol After admission, patients were given intravenous analgetics, omeprazole and somatostatin, and nasojejunal tubes were placed for EN. Once fever developed, broad-spectrum antibiotics were given empirically. If the patient was concomitant with shock, respiratory failure, and acute kidney injury, appropriate organ support was provided. Patients with biliary pancreatitis was given encoscopic retrograde cholangiopancreato graphy (ERCP) within 24 h after admission. When the patient was diagnosed with hyperlipidemic pancreatitis and plasma triglyceride ≥11.3 mmol/L, plasma exchange was administered immediately. All patients were given contrast enhanced CT within 48 hours after admission to identify the location and range of the necrosis and calculate the CT severity index (CISI).
Procedure All PCD and endoscopic procedures were performed under conscious sedation or local anesthesia. If the patient's condition progressively worsened, a multifunctional irrigation-assisted vacuum drainage tube was placed by the CT-guided Seldinger technique in each of the necrosis cavity. The tube was administered with continuous internal irrigation and vacuum drainage as described in below: (1) the end of the drainage tube (the adapter) was connected to a vacuum device that delivers a controlled negative pressure within the range of 8-10 kPa. (2) a large volume of 0.9% normal saline was infused into the necrosis cavity constantly (1500mL a day, 65mL an hour) through the durg entrance, allowing for continuous irrigation; (3) the inside drainage tube was flush by rapid manual injection of 50-100 mL 0.9% normal saline twice a day through the drug entrance and inject 20-50 mL of 0.9% normal saline daily through water entrance to prevent the tube from becoming blocked by necrosis, debris or omentum; (4) total irrigation and drainage volume were checked every 8 hours to keep the irrigation-drainage balanced. All tubes were checked daily and replaced when the tube was translocated or blocked. When the volume of irrigation exceeds the drainage 500 mL/day or if there were serious complications associated with the drainage tube, continuous irrigation and vacuum drainage should be stopped immediately and the tube was the traditional drainage was performed.
Approximately 4 weeks after disease onset or the formation of well-defined wall was confirmed by repeat CT scan, transgastric necrosectomy were performed by one or two experienced endoscopist under conscious sedation. Transgastric necrosectomy was repeated, mostly every three to five days, until all loosely adherent necrotic material were cleared and replaced by granulation tissue. In the course of the procedure, antibiotic administration was adjusted based on the results of the microbiological culture results. Subsequently, percutaneous irrigation was stopped and replace with simple drainage if the patient's condition continues to improved and the cavity confirmed by CT was resolution. If the drainage volume was less than 10 mL/day for 3 consecutive days, clamp the drainage tube and remove it finally.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The study group | – | Procedure: Percutaneous Continuous Irrigation assisted Vacuum Drainage Combined With Transgastric NecrosectomyWe retrospectively analysis of 8 consecutive patients with SAP and IPN. SAP was diagnosed with persistent organ failure >48h. IPN was considered when the following situations occur: ≥38.5℃; increasing WBC, CRP or procalcitonin; rapid clinical deterioration; signs of gas was present in areas of necrosis. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with SAP and IPN;SAP was diagnosed according to the revised Atlanta classification, which defined simultaneous persistent single or multiple organ failure >48h;IPN was considered when the following situations occur: persistent fever ≥38.5℃; increasing blood white blood cells (WBC), C-reactive protein (CRP) or procalcitonin; rapid deterioration of clinical deterioration; signs of gas was present in areas of necrosis. IPN is confirmed when the patient undergoes fine needle aspiration and the culture was positive.
Key inclusion criteria (2 listed)
- Diagnosed with SAP
- Concurrent IPN
Key exclusion criteria (2 listed)
- Age <18 years or > 80 years
- Patients or family members disagreed with this study
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 |
|---|---|---|
| Percutaneous Continuous Irrigation assisted Vacuum Drainage Combined With Transgastric NecrosectomyAll patients with SAP were given contrast enhanced CT scan within 48 hours after admission to identify the location and range of the necrosis. If the patient's condition progressively worsened, a multifunctional irrigation-assisted vacuum drainage tube was placed by the CT-guided Seldinger technique in each of the necrosis cavity. Subsequently, transgastric necrosectomy were performed by one or two experienced endoscopist under conscious sedation. The procedure was repeated until all loosely adherent necrotic material were cleared and replaced by granulation tissue. Percutaneous irrigation was stopped and replace with simple drainage if the patient's condition continues to improved and the cavity confirmed by CT was resolution. If the drainage volume was less than 10 mL/day for 3 consecutive days, clamp the drainage tube and remove it finally. | Procedure or surgery | The study group |
Primary outcome
mortality
Time frame: Day28 after enrollment
28day-mortality
2 secondary outcomes
PCD
Time frame: From the first catheter placement to total catheter removal
endoscopic procedures
Time frame: through study completion, an average of 3 months
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 19 Aug 2022.
- Results publication: PubMed 20410514van Santvoort HC, Besselink MG, Bakker OJ, Hofker HS, Boermeester MA, Dejong CH, van Goor H, Schaapherder AF, van Eijck CH, Bollen TL, van Ramshorst B, Nieuwenhuijs VB, Timmer R, Lameris JS, Kruyt PM, Manusama ER, van der Harst E, van der Schelling GP, Karsten T, Hesselink EJ, van Laarhoven CJ, Rosman C, Bosscha K, de Wit RJ, Houdijk AP, van Leeuwen MS, Buskens E, Gooszen HG; Dutch Pancreatitis Study Group. A step-up approach or open necrosectomy for necrotizing pancreatitis. N Engl J Med. 2010 Apr 22;362(16):1491-502. doi: 10.1056/NEJMoa0908821.
- Results publication: PubMed 17446837Lee JK, Kwak KK, Park JK, Yoon WJ, Lee SH, Ryu JK, Kim YT, Yoon YB. The efficacy of nonsurgical treatment of infected pancreatic necrosis. Pancreas. 2007 May;34(4):399-404. doi: 10.1097/MPA.0b013e318043c0b1.
- Results publication: PubMed 19863956Ross A, Gluck M, Irani S, Hauptmann E, Fotoohi M, Siegal J, Robinson D, Crane R, Kozarek R. Combined endoscopic and percutaneous drainage of organized pancreatic necrosis. Gastrointest Endosc. 2010 Jan;71(1):79-84. doi: 10.1016/j.gie.2009.06.037. Epub 2009 Oct 27.
- Results publication: PubMed 29090245Sahar N, Kozarek R, Kanji ZS, Ross AS, Gluck M, Gan SI, Larsen M, Irani S. Do lumen-apposing metal stents (LAMS) improve treatment outcomes of walled-off pancreatic necrosis over plastic stents using dual-modality drainage? Endosc Int Open. 2017 Nov;5(11):E1052-E1059. doi: 10.1055/s-0043-111794. Epub 2017 Oct 26.
- Results publication: PubMed 30002773Jagielski M, Smoczynski M, Studniarek M, Adrych K. Endoscopic drainage combined with percutaneous drainage in treatment of walled-off pancreatic necrosis - a single-center experience. Prz Gastroenterol. 2018;13(2):137-142. doi: 10.5114/pg.2018.72604. Epub 2018 Jan 5.
- Derived from this study: PubMed 36930105Zhang B, Gao T, Wang Y, Zhu H, Liu S, Chen M, Yu W, Zhu Z. A novel mini-invasive step-up approach for the treatment of severe acute pancreatitis with extensive infected necrosis: A single center case series study. Medicine (Baltimore). 2023 Mar 17;102(11):e33288. doi: 10.1097/MD.0000000000033288.
- Individual participant dataSharing planned: No
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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.
Wenkui Yu, Ph.D study chair
Study concept and study design
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 Severe Acute Pancreatitis and Pancreatic Necrosis, run by Chinese Medical Association 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 2 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 19 Aug 2022. 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?
mortality (time frame: Day28 after enrollment). 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 NCT05508828, which also lists 6 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 19 Aug 2022.