Trauma InjuryNCT04080479
Bolus Versus Continuous Enteral Tube Feeding
A study testing Quadriceps Muscle Layer Fitness, Muscle Strength and Acute Physiology and Chronic Health Evaluation in people with Trauma Injury and Major Abdominal Surgery, run by University Hospital Ostrava at 1 site in Czechia.
Trial summary
Stress metabolisms induced by severe trauma, large abdominal surgery procedures, sepsis, etc. leads to metabolic changes, which increase energy expenditure, enhanced protein catabolism, insulin resistance. Muscle proteolysis is massively stimulated. Critically ill patients pay for survival with a loss of muscles. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma Injury, Major Abdominal Surgery, Sepsis
- What is being tested?
- Quadriceps Muscle Layer Fitness, Muscle Strength and Acute Physiology and Chronic Health Evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Oct 2019to 31 Dec 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- polytrauma
- major abdominal surgery
- sepsis
- ICU stay
- enteral feeding tube
- artificial ventilation
Who cannot join
- contraindication of enteral feeding
- infaust prognosis
- prolonged shock (more than 24 hours)
Trial locations and contacts
1 site in 1 country.
Czechia1 site
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 70852
About this study
Official title: Bolus Versus Continuous Enteral Feeding in Critically Ill Patients
Stress metabolisms induced by severe trauma, large abdominal surgery procedures, sepsis, etc. leads to metabolic changes, which increase energy expenditure, enhanced protein catabolism, insulin resistance. Muscle proteolysis is massively stimulated. Critically ill patients pay for survival with a loss of muscles. Enteral nutrition, especially protein delivery to critically ill, is very important for optimizing their outcome. Standard enteral feeding regiments are generally based on continuous feeding, which is thought to be better tolerated by critically ill patients with easier glycaemic control by continuous infusion of insulin, translated in less glycaemic variability. But this approach is not physiological, continuous feeding does not allow protein synthesis. Optimal protein synthesis requires a pulsatile increase in branched-chain amino acids. Bolus feeding activates the entrohormonal axis (bioactive peptides, insulin), and stimulates skeletal muscle synthesis to the maximum extent. The question is, whether bolus enteral feeding in critically ill patients with limited gastrointestinal function delivers a greater amount of protein, improves nutritional parameters, with higher quadriceps muscle layer thickness (QMLT) and muscle strength.
Read the detailed description
The trial has been designed in accordance with the Recommendations for Interventional Trials (SPIRIT 2013) and the Consolidated Standards for Reporting of Trials CONSORT guidelines.
Patients who meet the study inclusion criteria (severe trauma patients, surgical patients and medical patients with sepsis, with inserted nasogastric/nasoduodenal feed-ing tube) will be eligible to participate, especially patients who are mechanically ventilated. The last criterion is not a necessary precondition (a module of indirect calorimetry will be used in these patients). The necessary condition is the elimination of shock within 24 hours from the ICU admission and tolerance of trophic enteral feed-ing (20ml/hour) at for the period of at least 24 hours. Patients will be randomized in a ratio of 1:1 within 72 hours of their admission to receive bolus or continuous enteral feeding (sealed envelopes method). In both groups, the same goals of energy and protein will be observed (Day 1-2: E 15 kcal/kg/day, protein 0.8-1 g/kg/day; Day 3-4: E 20 kcal/kg/day, protein 1. 2 g/kg/day; Day ≥ 5: E 25 kcal/kg/day, protein 1.5-2 g/kg/day), according to protocol. The bolus enteral group will receive the amount of enteral nutrition in six boluses (per 60min dose), the continuous enteral group will receive the amount using a pump, within the timeframe of 6am-24pm. The need for parenteral nutrition will be determined by treating clinical staff independently to group allocation.
Demographic data collection: (weight, high, BMI) and conditions (trauma, surgical, medical patients), Acute Physiology and Chronic Health Evaluation (APACHE) Sequential Organ Failure Assessment (SOFA), Nutritional Risk Screening (NRS 2002).
Daily observations: glucose, mean glucose changes, insulin (IU/d), energy and protein intake (administered calories divided by the calculated energy expenditure and administered protein divided by calculated protein intake) - Adjusted/calculated energy and protein (%). Feeding intolerance (tolerating less than 40% of requirements via the enteral route for ≥ 3 days, diarrhea ≥ 500ml per day or five bowel actions). Mechanically ventilated patients (Resting Energy Expenditure (REE) and Respiratory Quotient (RQ) measured with indirect calorimetry) Day 1, 3, 5, 7: Nutritional parameters (serum albumin prealbumin, C-reactive protein (CRP), urine urea, N balance).
Day 1 and 7: Muscle layer thickness (QMLT by ultrasound measurement and mid-upper arm circumference) and muscle strength (dynamometer) from baseline to discharge. Outcomes of muscle strength/ultrasound and dynamometer) will be measured by an investigator blinded to the group allocation.
- Conditions
- Trauma Injury, Major Abdominal Surgery, Sepsis
- Being tested
- Quadriceps Muscle Layer Fitness, Muscle Strength, Acute Physiology and Chronic Health Evaluation, Sequential Organ Failure Assessment, Nutritional Risk Screening
- Keywords
- bolus enteral feeding, continuous enteral feeding, protein synthesis, nutritional parameters
- Medical subject headings
- Accidental Injuries, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadriceps Muscle Layer FitnessDiagnostic test
Also called QMLF
The QMLF examination will be performed in all study subjects, with both bolus and continuous enteral feeding.
Muscle StrengthDiagnostic test
All study subjects, with both bolus and continuous enteral feeding, will undergo measurement of the muscle strength using dynamometer.
Acute Physiology and Chronic Health EvaluationDiagnostic test
Also called APACHE
All study subjects, with both bolus and continuous enteral feeding, will undergo the APACHE evaluation.
Sequential Organ Failure AssessmentDiagnostic test
Also called SOFA
All study subjects, with both bolus and continuous enteral feeding, will undergo the SOFA assessment.
Nutritional Risk ScreeningDiagnostic test
Also called NSR
All study subjects, with both bolus and continuous enteral feeding, will undergo the NSR screening.
Energy and Protein IntakeDiagnostic test
The amount of energy and protein supplied to the study subjects will be observed daily in all study subjects, with both bolus and continuous enteral feeding, the percentage of the planned daily intake will be analyzed.
| Study group | Role | What they receive |
|---|---|---|
| Bolus enteral feeding | Experimental | The patients randomized into this study arm will receive bolus enteral feeding. The study subjects will undergo the following interventions:
* Quadriceps Muscle Layer Fitness measurement
* Muscle Strength measurement
* Acute Physiology and Chronic Health Evaluation
* Sequential Organ Failure Assessment
* Nutritional Risk Screening
* Energy and Protein Intake Receives: Diagnostic Test: Quadriceps Muscle Layer Fitness; Diagnostic Test: Muscle Strength; Diagnostic Test: Acute Physiology and Chronic Health Evaluation; Diagnostic Test: Sequential Organ Failure Assessment; Diagnostic Test: Nutritional Risk Screening; Diagnostic Test: Energy and Protein Intake |
| Continuous enteral feeding | Experimental | The patients randomized into this study arm will receive bolus enteral feeding.
The study subjects will undergo the following interventions:
* Quadriceps Muscle Layer Fitness measurement
* Muscle Strength measurement
* Acute Physiology and Chronic Health Evaluation
* Sequential Organ Failure Assessment
* Nutritional Risk Screening
* Energy and Protein Intake Receives: Diagnostic Test: Quadriceps Muscle Layer Fitness; Diagnostic Test: Muscle Strength; Diagnostic Test: Acute Physiology and Chronic Health Evaluation; Diagnostic Test: Sequential Organ Failure Assessment; Diagnostic Test: Nutritional Risk Screening; Diagnostic Test: Energy and Protein Intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in nutritional parameters - serum albumin
The development of the serum albumin levels in g/dL will be observed.
Measured: 7 days
Change in nutritional parameters - prealbumin
The development of the serum albumin levels in mg/dL will be observed.
Measured: 7 days
Change in inflammatory parameters - C-reactive protein (CRP)
The development of inflammatory parameters in mg/L will be observed.
Measured: 7 days
Change in muscle mass
The development of muscle mass (circumference in centimetres) will be measured.
Measured: 7 days
Change in muscle strength
The development of muscle strength (in kilograms) will be measured.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start1 Oct 2019
- Primary completion30 Sep 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Trauma InjuryStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study subjects will be randomized into one of the two study arms.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marcela Káňová, MD,PhD, Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04080479
- Sponsor's protocol ID
- FNO-KARIM-12-Enteral_Feeding
- Status last verified
- Dec 2022
- First submitted
- 3 Sep 2019
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers.
Publications
Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586.
PubMed 23303884Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2011;9(8):672-7. doi: 10.1016/j.ijsu.2011.09.004. Epub 2011 Oct 13. No abstract available.
PubMed 22019563Fetterplace K, Deane AM, Tierney A, Beach L, Knight LD, Rechnitzer T, Forsyth A, Mourtzakis M, Presneill J, MacIsaac C. Targeted full energy and protein delivery in critically ill patients: a study protocol for a pilot randomised control trial (FEED Trial). Pilot Feasibility Stud. 2018 Feb 20;4:52. doi: 10.1186/s40814-018-0249-9. eCollection 2018.
PubMed 29484196Tillquist M, Kutsogiannis DJ, Wischmeyer PE, Kummerlen C, Leung R, Stollery D, Karvellas CJ, Preiser JC, Bird N, Kozar R, Heyland DK. Bedside ultrasound is a practical and reliable measurement tool for assessing quadriceps muscle layer thickness. JPEN J Parenter Enteral Nutr. 2014 Sep;38(7):886-90. doi: 10.1177/0148607113501327. Epub 2013 Aug 26.
PubMed 23980134
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bolus Versus Continuous Enteral Feeding in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT04080479
- Acronym / sponsor ID
- FNO-KARIM-12-Enteral_Feeding
- Conditions
- Trauma Injury, Major Abdominal Surgery, Sepsis
- Keywords
- bolus enteral feeding, continuous enteral feeding, protein synthesis, nutritional parameters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 6 Sep 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.
Stress metabolisms induced by severe trauma, large abdominal surgery procedures, sepsis, etc. leads to metabolic changes, which increase energy expenditure, enhanced protein catabolism, insulin resistance. Muscle proteolysis is massively stimulated. Critically ill patients pay for survival with a loss of muscles. Enteral nutrition, especially protein delivery to critically ill, is very important for optimizing their outcome. Standard enteral feeding regiments are generally based on continuous feeding, which is thought to be better tolerated by critically ill patients with easier glycaemic control by continuous infusion of insulin, translated in less glycaemic variability. But this approach is not physiological, continuous feeding does not allow protein synthesis. Optimal protein synthesis requires a pulsatile increase in branched-chain amino acids. Bolus feeding activates the entrohormonal axis (bioactive peptides, insulin), and stimulates skeletal muscle synthesis to the maximum extent. The question is, whether bolus enteral feeding in critically ill patients with limited gastrointestinal function delivers a greater amount of protein, improves nutritional parameters, with higher quadriceps muscle layer thickness (QMLT) and muscle strength.
Detailed description
The trial has been designed in accordance with the Recommendations for Interventional Trials (SPIRIT 2013) and the Consolidated Standards for Reporting of Trials CONSORT guidelines.
Patients who meet the study inclusion criteria (severe trauma patients, surgical patients and medical patients with sepsis, with inserted nasogastric/nasoduodenal feed-ing tube) will be eligible to participate, especially patients who are mechanically ventilated. The last criterion is not a necessary precondition (a module of indirect calorimetry will be used in these patients). The necessary condition is the elimination of shock within 24 hours from the ICU admission and tolerance of trophic enteral feed-ing (20ml/hour) at for the period of at least 24 hours. Patients will be randomized in a ratio of 1:1 within 72 hours of their admission to receive bolus or continuous enteral feeding (sealed envelopes method). In both groups, the same goals of energy and protein will be observed (Day 1-2: E 15 kcal/kg/day, protein 0.8-1 g/kg/day; Day 3-4: E 20 kcal/kg/day, protein 1. 2 g/kg/day; Day ≥ 5: E 25 kcal/kg/day, protein 1.5-2 g/kg/day), according to protocol. The bolus enteral group will receive the amount of enteral nutrition in six boluses (per 60min dose), the continuous enteral group will receive the amount using a pump, within the timeframe of 6am-24pm. The need for parenteral nutrition will be determined by treating clinical staff independently to group allocation.
Demographic data collection: (weight, high, BMI) and conditions (trauma, surgical, medical patients), Acute Physiology and Chronic Health Evaluation (APACHE) Sequential Organ Failure Assessment (SOFA), Nutritional Risk Screening (NRS 2002).
Daily observations: glucose, mean glucose changes, insulin (IU/d), energy and protein intake (administered calories divided by the calculated energy expenditure and administered protein divided by calculated protein intake) - Adjusted/calculated energy and protein (%). Feeding intolerance (tolerating less than 40% of requirements via the enteral route for ≥ 3 days, diarrhea ≥ 500ml per day or five bowel actions). Mechanically ventilated patients (Resting Energy Expenditure (REE) and Respiratory Quotient (RQ) measured with indirect calorimetry) Day 1, 3, 5, 7: Nutritional parameters (serum albumin prealbumin, C-reactive protein (CRP), urine urea, N balance).
Day 1 and 7: Muscle layer thickness (QMLT by ultrasound measurement and mid-upper arm circumference) and muscle strength (dynamometer) from baseline to discharge. Outcomes of muscle strength/ultrasound and dynamometer) will be measured by an investigator blinded to the group allocation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study subjects will be randomized into one of the two study arms.
| Arm | Type | Receives |
|---|---|---|
| Bolus enteral feeding | Experimental | Diagnostic Test: Quadriceps Muscle Layer Fitness, Diagnostic Test: Muscle Strength, Diagnostic Test: Acute Physiology and Chronic Health Evaluation, Diagnostic Test: Sequential Organ Failure Assessment, Diagnostic Test: Nutritional Risk Screening, Diagnostic Test: Energy and Protein IntakeThe patients randomized into this study arm will receive bolus enteral feeding. The study subjects will undergo the following interventions: * Quadriceps Muscle Layer Fitness measurement * Muscle Strength measurement * Acute Physiology and Chronic Health Evaluation * Sequential Organ Failure Assessment * Nutritional Risk Screening * Energy and Protein Intake |
| Continuous enteral feeding | Experimental | Diagnostic Test: Quadriceps Muscle Layer Fitness, Diagnostic Test: Muscle Strength, Diagnostic Test: Acute Physiology and Chronic Health Evaluation, Diagnostic Test: Sequential Organ Failure Assessment, Diagnostic Test: Nutritional Risk Screening, Diagnostic Test: Energy and Protein IntakeThe patients randomized into this study arm will receive bolus enteral feeding. The study subjects will undergo the following interventions: * Quadriceps Muscle Layer Fitness measurement * Muscle Strength measurement * Acute Physiology and Chronic Health Evaluation * Sequential Organ Failure Assessment * Nutritional Risk Screening * Energy and Protein Intake |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- polytrauma
- major abdominal surgery
- sepsis
- ICU stay
- enteral feeding tube
Key exclusion criteria (3 listed)
- contraindication of enteral feeding
- infaust prognosis
- prolonged shock (more than 24 hours)
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 |
|---|---|---|
| Quadriceps Muscle Layer FitnessAlso: QMLFThe QMLF examination will be performed in all study subjects, with both bolus and continuous enteral feeding. | Diagnostic test | Bolus enteral feeding, Continuous enteral feeding |
| Muscle StrengthAll study subjects, with both bolus and continuous enteral feeding, will undergo measurement of the muscle strength using dynamometer. | Diagnostic test | Bolus enteral feeding, Continuous enteral feeding |
| Acute Physiology and Chronic Health EvaluationAlso: APACHEAll study subjects, with both bolus and continuous enteral feeding, will undergo the APACHE evaluation. | Diagnostic test | Bolus enteral feeding, Continuous enteral feeding |
| Sequential Organ Failure AssessmentAlso: SOFAAll study subjects, with both bolus and continuous enteral feeding, will undergo the SOFA assessment. | Diagnostic test | Bolus enteral feeding, Continuous enteral feeding |
| Nutritional Risk ScreeningAlso: NSRAll study subjects, with both bolus and continuous enteral feeding, will undergo the NSR screening. | Diagnostic test | Bolus enteral feeding, Continuous enteral feeding |
| Energy and Protein IntakeThe amount of energy and protein supplied to the study subjects will be observed daily in all study subjects, with both bolus and continuous enteral feeding, the percentage of the planned daily intake will be analyzed. | Diagnostic test | Bolus enteral feeding, Continuous enteral feeding |
Primary outcome
Change in nutritional parameters - serum albumin
Time frame: 7 days
The development of the serum albumin levels in g/dL will be observed.
Change in nutritional parameters - prealbumin
Time frame: 7 days
The development of the serum albumin levels in mg/dL will be observed.
Change in inflammatory parameters - C-reactive protein (CRP)
Time frame: 7 days
The development of inflammatory parameters in mg/L will be observed.
Change in muscle mass
Time frame: 7 days
The development of muscle mass (circumference in centimetres) will be measured.
Change in muscle strength
Time frame: 7 days
The development of muscle strength (in kilograms) will be measured.
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 7 Dec 2022.
- Background: PubMed 23303884Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586.
- Background: PubMed 22019563Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2011;9(8):672-7. doi: 10.1016/j.ijsu.2011.09.004. Epub 2011 Oct 13. No abstract available.
- Background: PubMed 29484196Fetterplace K, Deane AM, Tierney A, Beach L, Knight LD, Rechnitzer T, Forsyth A, Mourtzakis M, Presneill J, MacIsaac C. Targeted full energy and protein delivery in critically ill patients: a study protocol for a pilot randomised control trial (FEED Trial). Pilot Feasibility Stud. 2018 Feb 20;4:52. doi: 10.1186/s40814-018-0249-9. eCollection 2018.
- Background: PubMed 23980134Tillquist M, Kutsogiannis DJ, Wischmeyer PE, Kummerlen C, Leung R, Stollery D, Karvellas CJ, Preiser JC, Bird N, Kozar R, Heyland DK. Bedside ultrasound is a practical and reliable measurement tool for assessing quadriceps muscle layer thickness. JPEN J Parenter Enteral Nutr. 2014 Sep;38(7):886-90. doi: 10.1177/0148607113501327. Epub 2013 Aug 26.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers.
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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.
Marcela Káňová, MD,PhD principal investigator
University Hospital Ostrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quadriceps Muscle Layer Fitness, Muscle Strength and Acute Physiology and Chronic Health Evaluation in people with Trauma Injury and Major Abdominal Surgery, run by University Hospital Ostrava at 1 site in Czechia.
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 6 inclusion and 3 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 7 Dec 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 Czechia. 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?
Change in nutritional parameters - serum albumin (time frame: 7 days). The study lists 5 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 NCT04080479, which also lists 4 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 7 Dec 2022.