Pancreatitis, AcutePADINCT03829085
Study of the Diet in Patients With the Diagnostic of Acute Pancreatitis
A study testing EARLY ORAL REFEEDING in people with Pancreatitis, Acute, run by Consorci Sanitari del Garraf at 1 site in Spain.
Trial summary
Acute pancreatitis (AP) is a common condition in emergency services worldwide. Approximately 85% of AP are mild and the patients usually recover within 1 to 2 weeks, not requeiring any critical care and organ support. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Pancreatitis, Acute
- What is being tested?
- EARLY ORAL REFEEDING
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2017to 31 Dec 2018
- Phase
- Interventional
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Diagnosed of AP by at least two of these three criteria: compatible abdominal pain, amylase or lipase level superior in three-fold respective laboratory baseline levels, and suitable findings in imaging techniques (CT, ultrasound or MRI)
- 2) age > 18 years, sign consent form.
Who cannot join
- 1) pregnant o breastfeeding women;
- 2) abdominal pain lasting >96 horas before admission;
- 3) the possibility of poor oral intake for reasons other than AP;
- 4) Pancreatic neoplasm, endoscopic retrograde cholangiopancreatography or trauma etiology;
- 5) Chronic pancreatitis;
- 6) Randomization greater the 12 hours after admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Multicenter Prospective Clinical Trial to Compare the Effectiveness of Starting Early Oral Diet Versus Nil Per Oral in Patients With Acute Pancreatitis
Acute pancreatitis (AP) is a common condition in emergency services worldwide. Approximately 85% of AP are mild and the patients usually recover within 1 to 2 weeks, not requeiring any critical care and organ support. The management of mild AP conventionally involves fasting, intravenous hydration and adequate analgesia until pain improves in order to prevent stimulation and allow the pancreas gland to rest.
The current guidelines recommend the oral food intake should be tried as soon as possible, and beneficial effects or early enteral nutrition with mild AP have been reported in literature.
Then, early oral refeeding (EORF) after mild and moderate AP is beneficial, but the optimal timing and starting criteria are unclear. Even now, refeeding after mild and moderate AP is typically started until clinical symptoms have resolved and pancreatic enzymes are decreasing, in a successively increasing manner. The aim of this study is to evaluate length of hospital stay, clinical findings and complications for EORF with immediately full caloric intake in patients with mild and moderate AP.
Read the detailed description
This is prospective, randomized, controlled, multicentre trial. Patients with mild and moderate acute pancreatitis (AP) will be randomly in two groups: group A: with early oral refeeding (EOR) with low fat solid diet (LFSD), started from the first day of admission in the hospital, and group B: with Nil Per Oral (NPO), until the symptoms, signs, inflammatory parameters of AP have resolved.
The primary and several secondary endpoints will be obtained and EORF with LFSD will improve the following measures of outcome:
- Length of hospital admission (the primary endpoint)
- Serum amylase, lipase, electrolytes, calcium, urea, creatinine, liver function tests, C-reactive protein (biomarker of inflammation), nutritional parameters (albumin, prealbumin, cholesterol, triglycerides) and full blood count - routine blood tests performed daily until normalization of serum lipase or until discharge.
- Weight, at hospital admission and discharge, and at day 30 post-discharge clinic follow-up.
- Systemic complications including hemodynamic instability, renal failure, intensive care admission, surgery, radiological and endoscopic procedures.
- Pain and Analgesic requirement.
- Local complications including pancreatic necrosis, abscess, pseudocyst.
- Conditions
- Pancreatitis, Acute
- Being tested
- EARLY ORAL REFEEDING
- Keywords
- Acute Pancreatitis, Oral refeeding, Nutrition, Length hospitalization
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EARLY ORAL REFEEDINGOther
the oral refeeding will be started after admission. Patients will receive a low fat solid diet with more and less 1500 calories, 35 g fat day
| Study group | Role | What they receive |
|---|---|---|
| Early oral refeeding | Active comparator | The patients will be started the oral refeeding from the first day of admission in the hospital.
Patients will receive a low fat solid diet with more and less 1500 calories, 35 g fat day Receives: Other: EARLY ORAL REFEEDING |
| FASTING | No intervention | The oral diet will be reintroduced in a traditional stepwise manner until the symptoms, signs, inflammatory parameters of AP have resolved |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospitalization
Days
Measured: measured from onset of admission until time of actual discharge from hospital. Assessed between 1-10 days up to 14 days.
Secondary outcomes (7)
Relapse of abdominal pain
Pain Scale: 0=No pain, 1=Very mild, 2=Discomforting, 3=Tolerable, 4=Distressing, 5=Distressing, 6=Intense pain, 7=Very intense pain, 8=Horrible pain, 9=Excruciating, 10=Unimaginable pain
Measured: measured from onset of admission until time of actual discharge from hospital. Assessed between 1-10 days up to 14 days, and during the follow up (1 month after discharge)
Duration of fasting
Days
Measured: 2-3 days approximately since the first day of hospital admission
Tolerance to food
The patient's symptoms are controlled with the established treatment and the patient can eat at least 50% of the meals
Measured: 2-7 days approximately during hospital admission and during the follow up
Elevation of serum amylase or lipase
Elevation amylase or lipase level after oral refeeding
Measured: 2-4 days approximately during hospital admission after oral refeeding, until hospital discharge
Intra-abdominal infection
Fever: temperature greater than 38 or positive cultures of blood or pancreatic necrosis
Measured: 1 month
Death
Mortality
Measured: During hospital stay (up to 1 day)
Operation rate
The rate of patients received operation for pancreatitis debridement
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start1 Jun 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Pancreatitis, AcuteStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari del Garraf
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitari Joan XXIII de Tarragona., Hospital Clinic of Barcelona
- Responsible party
- Principal investigator, Elena Ramírez-Maldonado, Consorci Sanitari del Garraf
- Investigators
- Elena Ramírez-Maldonado, MD, Principal investigator, Consorcio Sanitari del Garraf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03829085
- Sponsor's protocol ID
- PADI_01
- Acronym
- PADI
- Status last verified
- Feb 2019
- First submitted
- 27 Jan 2019
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The results of this trial will be published in an open access way and disseminates among medical societies
Publications
Greenberg JA, Hsu J, Bawazeer M, Marshall J, Friedrich JO, Nathens A, Coburn N, May GR, Pearsall E, McLeod RS. Clinical practice guideline: management of acute pancreatitis. Can J Surg. 2016 Apr;59(2):128-40. doi: 10.1503/cjs.015015.
PubMed 27007094Tenner S, Baillie J, DeWitt J, Vege SS; American College of Gastroenterology. American College of Gastroenterology guideline: management of acute pancreatitis. Am J Gastroenterol. 2013 Sep;108(9):1400-15; 1416. doi: 10.1038/ajg.2013.218. Epub 2013 Jul 30.
PubMed 23896955Bevan MG, Asrani VM, Bharmal S, Wu LM, Windsor JA, Petrov MS. Incidence and predictors of oral feeding intolerance in acute pancreatitis: A systematic review, meta-analysis, and meta-regression. Clin Nutr. 2017 Jun;36(3):722-729. doi: 10.1016/j.clnu.2016.06.006. Epub 2016 Jun 16.
PubMed 27346178Lodewijkx PJ, Besselink MG, Witteman BJ, Schepers NJ, Gooszen HG, van Santvoort HC, Bakker OJ; Dutch Pancreatitis Study Group. Nutrition in acute pancreatitis: a critical review. Expert Rev Gastroenterol Hepatol. 2016;10(5):571-80. doi: 10.1586/17474124.2016.1141048. Epub 2016 Mar 15.
PubMed 26823272Jacobson BC, Vander Vliet MB, Hughes MD, Maurer R, McManus K, Banks PA. A prospective, randomized trial of clear liquids versus low-fat solid diet as the initial meal in mild acute pancreatitis. Clin Gastroenterol Hepatol. 2007 Aug;5(8):946-51; quiz 886. doi: 10.1016/j.cgh.2007.04.012. Epub 2007 Jul 5.
PubMed 17613280Eckerwall GE, Tingstedt BB, Bergenzaun PE, Andersson RG. Immediate oral feeding in patients with mild acute pancreatitis is safe and may accelerate recovery--a randomized clinical study. Clin Nutr. 2007 Dec;26(6):758-63. doi: 10.1016/j.clnu.2007.04.007. Epub 2007 Aug 24.
PubMed 17719703Li J, Xue GJ, Liu YL, Javed MA, Zhao XL, Wan MH, Chen GY, Altaf K, Huang W, Tang WF. Early oral refeeding wisdom in patients with mild acute pancreatitis. Pancreas. 2013 Jan;42(1):88-91. doi: 10.1097/MPA.0b013e3182575fb5.
PubMed 22836861Olah A, Romics L Jr. Enteral nutrition in acute pancreatitis: a review of the current evidence. World J Gastroenterol. 2014 Nov 21;20(43):16123-31. doi: 10.3748/wjg.v20.i43.16123.
PubMed 25473164Petrov MS, van Santvoort HC, Besselink MG, Cirkel GA, Brink MA, Gooszen HG. Oral refeeding after onset of acute pancreatitis: a review of literature. Am J Gastroenterol. 2007 Sep;102(9):2079-84; quiz 2085. doi: 10.1111/j.1572-0241.2007.01357.x. Epub 2007 Jun 16.
PubMed 17573797Zhao XL, Zhu SF, Xue GJ, Li J, Liu YL, Wan MH, Huang W, Xia Q, Tang WF. Early oral refeeding based on hunger in moderate and severe acute pancreatitis: a prospective controlled, randomized clinical trial. Nutrition. 2015 Jan;31(1):171-5. doi: 10.1016/j.nut.2014.07.002. Epub 2014 Jul 30.
PubMed 25441594Petrov MS, Pylypchuk RD, Uchugina AF. A systematic review on the timing of artificial nutrition in acute pancreatitis. Br J Nutr. 2009 Mar;101(6):787-93. doi: 10.1017/S0007114508123443. Epub 2008 Nov 19.
PubMed 19017421Li X, Ma F, Jia K. Early enteral nutrition within 24 hours or between 24 and 72 hours for acute pancreatitis: evidence based on 12 RCTs. Med Sci Monit. 2014 Nov 17;20:2327-35. doi: 10.12659/MSM.892770.
PubMed 25399541Larino-Noia J, Lindkvist B, Iglesias-Garcia J, Seijo-Rios S, Iglesias-Canle J, Dominguez-Munoz JE. Early and/or immediately full caloric diet versus standard refeeding in mild acute pancreatitis: a randomized open-label trial. Pancreatology. 2014 May-Jun;14(3):167-73. doi: 10.1016/j.pan.2014.02.008. Epub 2014 Mar 14.
PubMed 24854611Ramirez-Maldonado E, Lopez Gordo S, Pueyo EM, Sanchez-Garcia A, Mayol S, Gonzalez S, Elvira J, Memba R, Fondevila C, Jorba R. Immediate Oral Refeeding in Patients With Mild and Moderate Acute Pancreatitis: A Multicenter, Randomized Controlled Trial (PADI trial). Ann Surg. 2021 Aug 1;274(2):255-263. doi: 10.1097/SLA.0000000000004596.
PubMed 33196485
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Multicenter Prospective Clinical Trial to Compare the Effectiveness of Starting Early Oral Diet Versus Nil Per Oral in Patients With Acute Pancreatitis
- ClinicalTrials.gov ID
- NCT03829085
- Acronym / sponsor ID
- PADI / PADI_01
- Conditions
- Pancreatitis, Acute
- Keywords
- Acute Pancreatitis, Oral refeeding, Nutrition, Length hospitalization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Consorci Sanitari del GarrafUniversity, hospital or other
- Collaborators
- Hospital Universitari Joan XXIII de Tarragona., Hospital Clinic of Barcelona
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 4 Feb 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.
Acute pancreatitis (AP) is a common condition in emergency services worldwide. Approximately 85% of AP are mild and the patients usually recover within 1 to 2 weeks, not requeiring any critical care and organ support. The management of mild AP conventionally involves fasting, intravenous hydration and adequate analgesia until pain improves in order to prevent stimulation and allow the pancreas gland to rest.
The current guidelines recommend the oral food intake should be tried as soon as possible, and beneficial effects or early enteral nutrition with mild AP have been reported in literature.
Then, early oral refeeding (EORF) after mild and moderate AP is beneficial, but the optimal timing and starting criteria are unclear. Even now, refeeding after mild and moderate AP is typically started until clinical symptoms have resolved and pancreatic enzymes are decreasing, in a successively increasing manner. The aim of this study is to evaluate length of hospital stay, clinical findings and complications for EORF with immediately full caloric intake in patients with mild and moderate AP.
Detailed description
This is prospective, randomized, controlled, multicentre trial. Patients with mild and moderate acute pancreatitis (AP) will be randomly in two groups: group A: with early oral refeeding (EOR) with low fat solid diet (LFSD), started from the first day of admission in the hospital, and group B: with Nil Per Oral (NPO), until the symptoms, signs, inflammatory parameters of AP have resolved.
The primary and several secondary endpoints will be obtained and EORF with LFSD will improve the following measures of outcome:
- Length of hospital admission (the primary endpoint)
- Serum amylase, lipase, electrolytes, calcium, urea, creatinine, liver function tests, C-reactive protein (biomarker of inflammation), nutritional parameters (albumin, prealbumin, cholesterol, triglycerides) and full blood count - routine blood tests performed daily until normalization of serum lipase or until discharge.
- Weight, at hospital admission and discharge, and at day 30 post-discharge clinic follow-up.
- Systemic complications including hemodynamic instability, renal failure, intensive care admission, surgery, radiological and endoscopic procedures.
- Pain and Analgesic requirement.
- Local complications including pancreatic necrosis, abscess, pseudocyst.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early oral refeeding | Active comparator | Other: EARLY ORAL REFEEDINGThe patients will be started the oral refeeding from the first day of admission in the hospital. Patients will receive a low fat solid diet with more and less 1500 calories, 35 g fat day |
| FASTING | No intervention | –The oral diet will be reintroduced in a traditional stepwise manner until the symptoms, signs, inflammatory parameters of AP have resolved |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1) Diagnosed of AP by at least two of these three criteria: compatible abdominal pain, amylase or lipase level superior in three-fold respective laboratory baseline levels, and suitable findings in imaging techniques (CT, ultrasound or MRI)
- 2) age > 18 years, sign consent form.
Key exclusion criteria (6 listed)
- 1) pregnant o breastfeeding women;
- 2) abdominal pain lasting >96 horas before admission;
- 3) the possibility of poor oral intake for reasons other than AP;
- 4) Pancreatic neoplasm, endoscopic retrograde cholangiopancreatography or trauma etiology;
- 5) Chronic pancreatitis;
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 |
|---|---|---|
| EARLY ORAL REFEEDINGthe oral refeeding will be started after admission. Patients will receive a low fat solid diet with more and less 1500 calories, 35 g fat day | Other | Early oral refeeding |
Primary outcome
Length of hospitalization
Time frame: measured from onset of admission until time of actual discharge from hospital. Assessed between 1-10 days up to 14 days.
Days
7 secondary outcomes
Relapse of abdominal pain
Time frame: measured from onset of admission until time of actual discharge from hospital. Assessed between 1-10 days up to 14 days, and during the follow up (1 month after discharge)
Duration of fasting
Time frame: 2-3 days approximately since the first day of hospital admission
Tolerance to food
Time frame: 2-7 days approximately during hospital admission and during the follow up
Elevation of serum amylase or lipase
Time frame: 2-4 days approximately during hospital admission after oral refeeding, until hospital discharge
Intra-abdominal infection
Time frame: 1 month
Death
Time frame: During hospital stay (up to 1 day)
Operation rate
Time frame: 2 month
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 5 Feb 2019.
- Background: PubMed 27007094Greenberg JA, Hsu J, Bawazeer M, Marshall J, Friedrich JO, Nathens A, Coburn N, May GR, Pearsall E, McLeod RS. Clinical practice guideline: management of acute pancreatitis. Can J Surg. 2016 Apr;59(2):128-40. doi: 10.1503/cjs.015015.
- Background: PubMed 23896955Tenner S, Baillie J, DeWitt J, Vege SS; American College of Gastroenterology. American College of Gastroenterology guideline: management of acute pancreatitis. Am J Gastroenterol. 2013 Sep;108(9):1400-15; 1416. doi: 10.1038/ajg.2013.218. Epub 2013 Jul 30.
- Background: PubMed 27346178Bevan MG, Asrani VM, Bharmal S, Wu LM, Windsor JA, Petrov MS. Incidence and predictors of oral feeding intolerance in acute pancreatitis: A systematic review, meta-analysis, and meta-regression. Clin Nutr. 2017 Jun;36(3):722-729. doi: 10.1016/j.clnu.2016.06.006. Epub 2016 Jun 16.
- Results publication: PubMed 26823272Lodewijkx PJ, Besselink MG, Witteman BJ, Schepers NJ, Gooszen HG, van Santvoort HC, Bakker OJ; Dutch Pancreatitis Study Group. Nutrition in acute pancreatitis: a critical review. Expert Rev Gastroenterol Hepatol. 2016;10(5):571-80. doi: 10.1586/17474124.2016.1141048. Epub 2016 Mar 15.
- Results publication: PubMed 17613280Jacobson BC, Vander Vliet MB, Hughes MD, Maurer R, McManus K, Banks PA. A prospective, randomized trial of clear liquids versus low-fat solid diet as the initial meal in mild acute pancreatitis. Clin Gastroenterol Hepatol. 2007 Aug;5(8):946-51; quiz 886. doi: 10.1016/j.cgh.2007.04.012. Epub 2007 Jul 5.
- Results publication: PubMed 17719703Eckerwall GE, Tingstedt BB, Bergenzaun PE, Andersson RG. Immediate oral feeding in patients with mild acute pancreatitis is safe and may accelerate recovery--a randomized clinical study. Clin Nutr. 2007 Dec;26(6):758-63. doi: 10.1016/j.clnu.2007.04.007. Epub 2007 Aug 24.
- Results publication: PubMed 22836861Li J, Xue GJ, Liu YL, Javed MA, Zhao XL, Wan MH, Chen GY, Altaf K, Huang W, Tang WF. Early oral refeeding wisdom in patients with mild acute pancreatitis. Pancreas. 2013 Jan;42(1):88-91. doi: 10.1097/MPA.0b013e3182575fb5.
- Results publication: PubMed 25473164Olah A, Romics L Jr. Enteral nutrition in acute pancreatitis: a review of the current evidence. World J Gastroenterol. 2014 Nov 21;20(43):16123-31. doi: 10.3748/wjg.v20.i43.16123.
- Results publication: PubMed 17573797Petrov MS, van Santvoort HC, Besselink MG, Cirkel GA, Brink MA, Gooszen HG. Oral refeeding after onset of acute pancreatitis: a review of literature. Am J Gastroenterol. 2007 Sep;102(9):2079-84; quiz 2085. doi: 10.1111/j.1572-0241.2007.01357.x. Epub 2007 Jun 16.
- Results publication: PubMed 25441594Zhao XL, Zhu SF, Xue GJ, Li J, Liu YL, Wan MH, Huang W, Xia Q, Tang WF. Early oral refeeding based on hunger in moderate and severe acute pancreatitis: a prospective controlled, randomized clinical trial. Nutrition. 2015 Jan;31(1):171-5. doi: 10.1016/j.nut.2014.07.002. Epub 2014 Jul 30.
- Results publication: PubMed 19017421Petrov MS, Pylypchuk RD, Uchugina AF. A systematic review on the timing of artificial nutrition in acute pancreatitis. Br J Nutr. 2009 Mar;101(6):787-93. doi: 10.1017/S0007114508123443. Epub 2008 Nov 19.
- Results publication: PubMed 25399541Li X, Ma F, Jia K. Early enteral nutrition within 24 hours or between 24 and 72 hours for acute pancreatitis: evidence based on 12 RCTs. Med Sci Monit. 2014 Nov 17;20:2327-35. doi: 10.12659/MSM.892770.
- Individual participant dataSharing planned: Yes. The results of this trial will be published in an open access way and disseminates among medical societies
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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.
Elena Ramírez-Maldonado, MD principal investigator
Consorcio Sanitari del Garraf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EARLY ORAL REFEEDING in people with Pancreatitis, Acute, run by Consorci Sanitari del Garraf at 1 site in Spain.
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 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 5 Feb 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 Spain. 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?
Length of hospitalization (time frame: measured from onset of admission until time of actual discharge from hospital. Assessed between 1-10 days up to 14 days.). 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 NCT03829085, which also lists 14 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 5 Feb 2019.