Major Abdominal/GI SurgeryNCT03692507
Effects of Nutritional Preconditioning on the Patient's Outcomes After Surgery
A study testing HMB, Protein and HMB and ERAS in people with Major Abdominal/GI Surgery, run by University of California, San Francisco at 1 site in United States.
Trial summary
Malnutrition is a serious problem in patients undergoing major surgeries and has a direct association with increased morbidity, mortality, length of stay (LOS), increased readmissions and cost of care. Studies suggest several advantages of supplementation with protein or specific amino acids in malnourished patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Major Abdominal/GI Surgery
- What is being tested?
- HMB, Protein and HMB and ERAS
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2021to 30 Dec 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Dr. Amir Fathi as attending surgeon
- Adult patients (age >18) undergoing major abdominal and GI surgeries
- Patients at risk for malnutrition based on the ASPEN and The Academy malnutrition criteria
Who cannot join
- Pediatric patients
- Patients undergoing chemotherapy or radiation
- Patients with known allergies to products (Ensure Enlive, HMB)
- Patients that are unable to comply with all requirements
- Vegan patients
- Pregnant patients
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Community Regional Medical Center
Fresno, California, 93721
Amir Fathi, Co-PI, 559-256-5140, AFathi@fresno.ucsf.edu
About this study
Official title: Effects of Nutritional Preconditioning on the Nutritional Status of Patients Undergoing Major General Surgeries and Subsequent Operative Outcomes
Malnutrition is a serious problem in patients undergoing major surgeries and has a direct association with increased morbidity, mortality, length of stay (LOS), increased readmissions and cost of care. Studies suggest several advantages of supplementation with protein or specific amino acids in malnourished patients. Dietary leucine or its metabolite β-hydroxy β-methylbutyrate (HMB) can improve skeletal muscle mass and function by increasing transcriptional level of protein synthase, while other high protein or amino acids like Glutamine or Arginine supplements only provide protein-amino acids pool for patients while body's preferred fuel during metabolic stress is endogens protein, rather than exogenous diet.
In this study the investigators seek to achieve two distinct goals:
- Determine the patients' nutritional status before and after major surgeries by baseline and subsequent nutritional assessments, according to ASPEN's criteria. In addition, the investigators were going to use indirect calorimetry to determine the Resting Energy Expenditure (REE) in different phases of pre- and postoperative periods. The investigators also propose to compare different serum protein markers and their ratios in order to correlate them with ASPEN's criteria for nutritional status quantification. In Summary, three discrete tools including ASPEN's criteria, indirect calorimetry, and serum biomarkers are going to be used in conjunction with each other to delineate the patients' nutritional status in various pre- and post-operative periods.
- Patients undergoing major surgeries were supplemented with high protein with ß-hydroxy ß-methylbutyrate (HMB) (Ensure, Envile) or HMB only as a control, in order to improve their nutritional status and improve postoperative outcomes. The investigators looked for depict meaningful improvements in surgical outcomes by nutritional supplementation with or without HMB.
Read the detailed description
Hypotheses:
We hypothesize that patients receiving high protein nutritional supplementation with HMB (Ensure Enlive) will have meaningful improvements in surgical outcomes rather than if they receive HMB only. Also, by comparing different methods of malnutrition designation, we are hypothesizing that by conduction this study, we will have a better understanding of malnutrition and its consequences in the Central Valley of California. Furthermore, we are planning to improve patient outcomes and significantly reduce the health care costs of the Valley by proper nutritional supplementation.
Specific Aims:
Demonstrate the important role β-hydroxy β-methyl butyrate (HMB) supplementation with or without high protein nutrition supplement in patients undergoing major surgeries and their outcomes.
Develop the current ERAS protocol used in Community Regional Medical Center by determining the best oral nutrition supplement prior to surgery Emphasize the importance of using oral nutrition supplements before major surgeries to decrease the patient's recovery after surgeries.
- Conditions
- Major Abdominal/GI Surgery
- Being tested
- HMB, Protein and HMB, ERAS
- Keywords
- HMB: β-hydroxy β-methylbutyrate, MNA: Mini Nutrition Assessment, GMS: Graz Malnutrition Screening, MUST: Malnutrition Universal Screening Tool, MST: Malnutrition Screening Tool, SGA: Subjective Global Assessment, REE: Resting Energy Expenditure, IC: Indirect calorimetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMBDietary supplement
Patients in the first group (HMB only) will take 3 capsules of HMB by VitaMonk™ (1000mg/capsule) daily (morning, noon, and night) for 5 days prior to surgery.
Protein and HMBDietary supplement
Patients in the second group (HMB + protein) will drink 2- 8oz bottles of Ensure Enlive daily (morning and night) for 5 days prior to surgery. Each bottle contains 1500mg of HMB and 20 g of protein.
ERASDietary supplement
Also called Protein
Patients in the third group (High protein) will drink 2- 8oz bottles of Ensure surgery daily (morning and night) for 5 days prior to surgery. Each bottle contains 18g of protein. and a clear 50g Pre-surgery drink on the day of surgery
| Study group | Role | What they receive |
|---|---|---|
| HMB only | Experimental | Taking HMB supplements three times a day Receives: Dietary Supplement: HMB |
| Protein and HMB | Experimental | Drinking Ensure Enlive shakes Receives: Dietary Supplement: Protein and HMB |
| Current ERAS (High Protein) | Experimental | Drinking Ensure surgery shakes + Ensure pre-surgery Receives: Dietary Supplement: ERAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient length of hospital stay
Length of hospital stay (LOS) will be measured for all participating patients. Average LOS in the intervention group will be compared with the average LOS in the control group.
Measured: day seven and day thirty after surgery
Secondary outcomes (1)
Change in transcriptional key proteins expression level
Western blot analysis of muscle obtained at biopsy from patients
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start30 Jul 2021 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Major Abdominal/GI SurgeryStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- California State university, Fresno, Department of Food Science and Nutrition
- Responsible party
- Sponsor
- Investigators
- Amir h Fathi, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03692507
- Sponsor's protocol ID
- 2018006
- Status last verified
- Jun 2021
- First submitted
- 5 Jun 2018
- Last updated
- 2 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Studley HO. Percentage of weight loss: a basic indicator of surgical risk in patients with chronic peptic ulcer. 1936. Nutr Hosp. 2001 Jul-Aug;16(4):141-3; discussion 140-1. No abstract available.
PubMed 11680474Fairfield KM, Askari R, Lipman TO, Sanfey H, Collins KA. Overview of perioperative nutritional support. UpToDate. Last full review/revision: September. 2014
Mueller C, Compher C, Ellen DM; American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) Board of Directors. A.S.P.E.N. clinical guidelines: Nutrition screening, assessment, and intervention in adults. JPEN J Parenter Enteral Nutr. 2011 Jan;35(1):16-24. doi: 10.1177/0148607110389335. No abstract available.
PubMed 21224430Corkins MR, Guenter P, DiMaria-Ghalili RA, Jensen GL, Malone A, Miller S, Patel V, Plogsted S, Resnick HE; American Society for Parenteral and Enteral Nutrition. Malnutrition diagnoses in hospitalized patients: United States, 2010. JPEN J Parenter Enteral Nutr. 2014 Feb;38(2):186-95. doi: 10.1177/0148607113512154. Epub 2013 Nov 18.
PubMed 24247093Gomes F, Emery PW, Weekes CE. Risk of Malnutrition Is an Independent Predictor of Mortality, Length of Hospital Stay, and Hospitalization Costs in Stroke Patients. J Stroke Cerebrovasc Dis. 2016 Apr;25(4):799-806. doi: 10.1016/j.jstrokecerebrovasdis.2015.12.017. Epub 2016 Jan 18.
PubMed 26796058McWhirter JP, Pennington CR. Incidence and recognition of malnutrition in hospital. BMJ. 1994 Apr 9;308(6934):945-8. doi: 10.1136/bmj.308.6934.945.
PubMed 8173401Gavazzi C, Colatruglio S, Valoriani F, Mazzaferro V, Sabbatini A, Biffi R, Mariani L, Miceli R. Impact of home enteral nutrition in malnourished patients with upper gastrointestinal cancer: A multicentre randomised clinical trial. Eur J Cancer. 2016 Sep;64:107-12. doi: 10.1016/j.ejca.2016.05.032. Epub 2016 Jul 5.
PubMed 27391922Keller H, Allard J, Vesnaver E, Laporte M, Gramlich L, Bernier P, Davidson B, Duerksen D, Jeejeebhoy K, Payette H. Barriers to food intake in acute care hospitals: a report of the Canadian Malnutrition Task Force. J Hum Nutr Diet. 2015 Dec;28(6):546-57. doi: 10.1111/jhn.12314. Epub 2015 Apr 20.
PubMed 25891798Gropper SS, Smith JL. Advanced nutrition and human metabolism: Cengage Learning; 2012.
Schlein KM, Coulter SP. Best practices for determining resting energy expenditure in critically ill adults. Nutr Clin Pract. 2014 Feb;29(1):44-55. doi: 10.1177/0884533613515002. Epub 2013 Dec 12.
PubMed 24336442Burden S, Todd C, Hill J, Lal S. Pre-operative nutrition support in patients undergoing gastrointestinal surgery. Cochrane Database Syst Rev. 2012 Nov 14;11:CD008879. doi: 10.1002/14651858.CD008879.pub2.
PubMed 23152265McClave SA, Martindale RG, Kiraly L. The use of indirect calorimetry in the intensive care unit. Curr Opin Clin Nutr Metab Care. 2013 Mar;16(2):202-8. doi: 10.1097/MCO.0b013e32835dbc54.
PubMed 23340008Fraipont V, Preiser JC. Energy estimation and measurement in critically ill patients. JPEN J Parenter Enteral Nutr. 2013 Nov;37(6):705-13. doi: 10.1177/0148607113505868. Epub 2013 Oct 10.
PubMed 24113283Roller RE, Eglseer D, Eisenberger A, Wirnsberger GH. The Graz Malnutrition Screening (GMS): a new hospital screening tool for malnutrition. Br J Nutr. 2016 Feb 28;115(4):650-7. doi: 10.1017/S0007114515004924. Epub 2015 Dec 14.
PubMed 26652856Karsegard VL, Ferlay O, Maisonneuve N, Kyle UG, Dupertuis YM, Genton L, Pichard C. [Simplified malnutrition screening tool: Malnutrition Universal Screening Tool (MUST)]. Rev Med Suisse Romande. 2004 Oct;124(10):601-5. French.
PubMed 15573502
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nutritional Preconditioning on the Nutritional Status of Patients Undergoing Major General Surgeries and Subsequent Operative Outcomes
- ClinicalTrials.gov ID
- NCT03692507
- Acronym / sponsor ID
- 2018006
- Conditions
- Major Abdominal/GI Surgery
- Keywords
- HMB: β-hydroxy β-methylbutyrate, MNA: Mini Nutrition Assessment, GMS: Graz Malnutrition Screening, MUST: Malnutrition Universal Screening Tool, MST: Malnutrition Screening Tool, SGA: Subjective Global Assessment, REE: Resting Energy Expenditure, IC: Indirect calorimetry
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- California State university, Fresno, Department of Food Science and Nutrition
- Study start
- 30 Jul 2021 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 2 Oct 2018 (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.
Malnutrition is a serious problem in patients undergoing major surgeries and has a direct association with increased morbidity, mortality, length of stay (LOS), increased readmissions and cost of care. Studies suggest several advantages of supplementation with protein or specific amino acids in malnourished patients. Dietary leucine or its metabolite β-hydroxy β-methylbutyrate (HMB) can improve skeletal muscle mass and function by increasing transcriptional level of protein synthase, while other high protein or amino acids like Glutamine or Arginine supplements only provide protein-amino acids pool for patients while body's preferred fuel during metabolic stress is endogens protein, rather than exogenous diet.
In this study the investigators seek to achieve two distinct goals:
- Determine the patients' nutritional status before and after major surgeries by baseline and subsequent nutritional assessments, according to ASPEN's criteria. In addition, the investigators were going to use indirect calorimetry to determine the Resting Energy Expenditure (REE) in different phases of pre- and postoperative periods. The investigators also propose to compare different serum protein markers and their ratios in order to correlate them with ASPEN's criteria for nutritional status quantification. In Summary, three discrete tools including ASPEN's criteria, indirect calorimetry, and serum biomarkers are going to be used in conjunction with each other to delineate the patients' nutritional status in various pre- and post-operative periods.
- Patients undergoing major surgeries were supplemented with high protein with ß-hydroxy ß-methylbutyrate (HMB) (Ensure, Envile) or HMB only as a control, in order to improve their nutritional status and improve postoperative outcomes. The investigators looked for depict meaningful improvements in surgical outcomes by nutritional supplementation with or without HMB.
Detailed description
Hypotheses:
We hypothesize that patients receiving high protein nutritional supplementation with HMB (Ensure Enlive) will have meaningful improvements in surgical outcomes rather than if they receive HMB only. Also, by comparing different methods of malnutrition designation, we are hypothesizing that by conduction this study, we will have a better understanding of malnutrition and its consequences in the Central Valley of California. Furthermore, we are planning to improve patient outcomes and significantly reduce the health care costs of the Valley by proper nutritional supplementation.
Specific Aims:
Demonstrate the important role β-hydroxy β-methyl butyrate (HMB) supplementation with or without high protein nutrition supplement in patients undergoing major surgeries and their outcomes.
Develop the current ERAS protocol used in Community Regional Medical Center by determining the best oral nutrition supplement prior to surgery Emphasize the importance of using oral nutrition supplements before major surgeries to decrease the patient's recovery after surgeries.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HMB only | Experimental | Dietary Supplement: HMBTaking HMB supplements three times a day |
| Protein and HMB | Experimental | Dietary Supplement: Protein and HMBDrinking Ensure Enlive shakes |
| Current ERAS (High Protein) | Experimental | Dietary Supplement: ERASDrinking Ensure surgery shakes + Ensure pre-surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Dr. Amir Fathi as attending surgeon
- Adult patients (age >18) undergoing major abdominal and GI surgeries
- Patients at risk for malnutrition based on the ASPEN and The Academy malnutrition criteria
Key exclusion criteria (7 listed)
- Pediatric patients
- Patients undergoing chemotherapy or radiation
- Patients with known allergies to products (Ensure Enlive, HMB)
- Patients that are unable to comply with all requirements
- Vegan patients
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 |
|---|---|---|
| HMBPatients in the first group (HMB only) will take 3 capsules of HMB by VitaMonk™ (1000mg/capsule) daily (morning, noon, and night) for 5 days prior to surgery. | Dietary supplement | HMB only |
| Protein and HMBPatients in the second group (HMB + protein) will drink 2- 8oz bottles of Ensure Enlive daily (morning and night) for 5 days prior to surgery. Each bottle contains 1500mg of HMB and 20 g of protein. | Dietary supplement | Protein and HMB |
| ERASAlso: ProteinPatients in the third group (High protein) will drink 2- 8oz bottles of Ensure surgery daily (morning and night) for 5 days prior to surgery. Each bottle contains 18g of protein. and a clear 50g Pre-surgery drink on the day of surgery | Dietary supplement | Current ERAS (High Protein) |
Primary outcome
Patient length of hospital stay
Time frame: day seven and day thirty after surgery
Length of hospital stay (LOS) will be measured for all participating patients. Average LOS in the intervention group will be compared with the average LOS in the control group.
1 secondary outcome
Change in transcriptional key proteins expression level
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
- Background: PubMed 11680474Studley HO. Percentage of weight loss: a basic indicator of surgical risk in patients with chronic peptic ulcer. 1936. Nutr Hosp. 2001 Jul-Aug;16(4):141-3; discussion 140-1. No abstract available.
- BackgroundFairfield KM, Askari R, Lipman TO, Sanfey H, Collins KA. Overview of perioperative nutritional support. UpToDate. Last full review/revision: September. 2014
- Background: PubMed 21224430Mueller C, Compher C, Ellen DM; American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) Board of Directors. A.S.P.E.N. clinical guidelines: Nutrition screening, assessment, and intervention in adults. JPEN J Parenter Enteral Nutr. 2011 Jan;35(1):16-24. doi: 10.1177/0148607110389335. No abstract available.
- Background: PubMed 24247093Corkins MR, Guenter P, DiMaria-Ghalili RA, Jensen GL, Malone A, Miller S, Patel V, Plogsted S, Resnick HE; American Society for Parenteral and Enteral Nutrition. Malnutrition diagnoses in hospitalized patients: United States, 2010. JPEN J Parenter Enteral Nutr. 2014 Feb;38(2):186-95. doi: 10.1177/0148607113512154. Epub 2013 Nov 18.
- Background: PubMed 26796058Gomes F, Emery PW, Weekes CE. Risk of Malnutrition Is an Independent Predictor of Mortality, Length of Hospital Stay, and Hospitalization Costs in Stroke Patients. J Stroke Cerebrovasc Dis. 2016 Apr;25(4):799-806. doi: 10.1016/j.jstrokecerebrovasdis.2015.12.017. Epub 2016 Jan 18.
- Background: PubMed 8173401McWhirter JP, Pennington CR. Incidence and recognition of malnutrition in hospital. BMJ. 1994 Apr 9;308(6934):945-8. doi: 10.1136/bmj.308.6934.945.
- Background: PubMed 27391922Gavazzi C, Colatruglio S, Valoriani F, Mazzaferro V, Sabbatini A, Biffi R, Mariani L, Miceli R. Impact of home enteral nutrition in malnourished patients with upper gastrointestinal cancer: A multicentre randomised clinical trial. Eur J Cancer. 2016 Sep;64:107-12. doi: 10.1016/j.ejca.2016.05.032. Epub 2016 Jul 5.
- Background: PubMed 25891798Keller H, Allard J, Vesnaver E, Laporte M, Gramlich L, Bernier P, Davidson B, Duerksen D, Jeejeebhoy K, Payette H. Barriers to food intake in acute care hospitals: a report of the Canadian Malnutrition Task Force. J Hum Nutr Diet. 2015 Dec;28(6):546-57. doi: 10.1111/jhn.12314. Epub 2015 Apr 20.
- BackgroundGropper SS, Smith JL. Advanced nutrition and human metabolism: Cengage Learning; 2012.
- Background: PubMed 24336442Schlein KM, Coulter SP. Best practices for determining resting energy expenditure in critically ill adults. Nutr Clin Pract. 2014 Feb;29(1):44-55. doi: 10.1177/0884533613515002. Epub 2013 Dec 12.
- Background: PubMed 23152265Burden S, Todd C, Hill J, Lal S. Pre-operative nutrition support in patients undergoing gastrointestinal surgery. Cochrane Database Syst Rev. 2012 Nov 14;11:CD008879. doi: 10.1002/14651858.CD008879.pub2.
- Background: PubMed 23340008McClave SA, Martindale RG, Kiraly L. The use of indirect calorimetry in the intensive care unit. Curr Opin Clin Nutr Metab Care. 2013 Mar;16(2):202-8. doi: 10.1097/MCO.0b013e32835dbc54.
- Individual participant dataSharing planned: Undecided
Related trials for Major Abdominal/GI Surgery
Not yet recruitingPhase 2
TU-100 for Accelerating GI Recovery After Major Abdominopelvic Surgery (RC & CAWR)
Delay in GI Recovery/Postoperative Ileus (POI)
Recruiting
Intraoperative Hypotension and Metabolomics in Major Upper Gastrointestinal Surgery
the Intraoperative Hypotension
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.
Amir h Fathi, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HMB, Protein and HMB and ERAS in people with Major Abdominal/GI Surgery, run by University of California, San Francisco at 1 site in United States.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 2 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amir H Fathi, MD ((559) 256-5140, AFathi@fresno.ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient length of hospital stay (time frame: day seven and day thirty after surgery). 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 NCT03692507, which also lists 34 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 2 Jul 2021.