AnesthesiaNCT05046925
PACU for Postoperative Care After Major Thoracic and Abdominal Surgery
An observational study of Anesthesia and Surgery--Complications, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
The aim of this study is to demonstrate the efficacy and safety of a specialised post-anaesthetic care unit (PACU) to a conventional intensive care unit (ICU) in adult patients after major thoracic and abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Surgery--Complications
- What is being tested?
- postoperatively transferral to PACU and postoperatively transferral to ICU
- Type of treatment
- Surgery or procedure
- How many people
- 18,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 31 Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing major thoracic and abdominal surgery between September, 2021 and September, 2023 will be included in this study
Who may be able to join
- Aged 18 years and older
- Undergoing major thoracic and abdominal surgery
- Postoperative hospital stay expected to be at least one night
- Patients requiring less than 24 hour stay in PACU or ICU
Who cannot join
- Patients aged less than 18 years
- Not receive major thoracic and abdominal surgery
- Stay in ICU is over 24 hours
- Hospital stay is less than 24 hours
- Patient not signing the informed consensus
Trial locations and contacts
1 site in 1 country.
China1 site
First affilated hospital of zhejiang university
Hangzhou, Zhejiang, 310000
Hui Li, Doctor, 8613968190081, lihuilcyx04@126.com
Hui Li, Professor, 8613857161019, xiangming_fang@163.com
About this study
Official title: PACU or ICU for Postoperative Care After Major Thoracic and Abdominal Surgery：a Prospective Randomized Clinical Trial
The aim of this study is to demonstrate the efficacy and safety of a specialised post-anaesthetic care unit (PACU) to a conventional intensive care unit (ICU) in adult patients after major thoracic and abdominal surgery. A better understanding of PACU for postoperative care is likely to reduce mortality and postoperative complications.
Read the detailed description
With the continuous progress of surgical techniques, the number of major thoracic and abdominal surgeries is also increasing. Although intensive monitoring and initiative treatment benefit patients undergoing major surgery, there is also an increasing demand for intensive care in hospitals, which can lead to capacity limitations in the intensive care unit (ICU). In addition, there is emerging opinion that many patients after major thoracic and abdominal surgery do not require ICU care postoperatively to be provided safe and appropriate care. For hospitals and their staff the challenge is to optimize clinical processes and to optimize the effectiveness of treatment in regard to patient's outcome. Studying patient postoperative care following major thoracic and abdominal surgery exposes many opportunities to the improvement of patient safety, tailor the intensive care resource allocation and consider the costs and benefits of the options.
Postoperative mortality and morbidity remain major challenges, and most of these complications develop during the early postoperative period when patients have left the recovery room. Thus improving the care that patients receive once complications have occurred is crucial for reducing mortality. The post-anesthetic care unit (PACU) provides general to intensive care to immediate postsurgical patients. Patients with major thoracic and abdominal surgery surgeries are often kept in PACU until their condition is stabilized before shifting them to their designated wards or ICU[9]. Ender et al. and Probs et al. showed that treatment in a specialized PACU rather than an ICU, after cardiac surgery leads to earlier extubation, decreased ICU length of stay (LOS) and quicker discharge of hospital without compromising patient safety. Kastrup et al. described, introduction of a PACU staffed with intensivist coverage around the clock might shorten the hospital LOS and more patients can be treated in the same time, due to a better use of resources. Some other study described the transferral to a PACU as an unfavourable option, since equipment, expertise and staffing levels in the PACU are different from the ICU.
The possible solution to this problem might be the inclusion of the PACU in the process of distribution of patients to the different levels of intensive care for ensuring the timely recognition and effective management of postoperative complications in patients after major thoracic and abdominal surgery. The most challenges are to identify those candidates who can be monitored PACU within 24 hours postoperatively, rather than in ICU, and implement change in care paradigms safely.
- Conditions
- Anesthesia, Surgery--Complications
- Being tested
- postoperatively transferral to PACU, postoperatively transferral to ICU
- Keywords
- Post-anesthetic care unit, Intensive care unit, Major surgery, postoperative complications, mortality, safety, efficacy, Postoperative care
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
postoperatively transferral to PACUProcedure or surgery
Also called 24-hour PACU group
patients undergoing major thoracic and abdominal surgery will be transferred to PACU for postoperative care.
postoperatively transferral to ICUProcedure or surgery
Also called 24-hour ICU group
patients undergoing major thoracic and abdominal surgery will be transferred to ICU for postoperative care.
| Study group | Role | What they receive |
|---|---|---|
| 24-hour PACU group | closely monitor in post-anesthetic unit (PACU) and the stay time is less than 24 hours, then patients can be discharged to floor Receives: Procedure: postoperatively transferral to PACU | |
| 24-hour ICU group | closely monitor in intensive care unit (ICU) and the stay time is less than 24 hours, even patients die within 24 hours in ICU Receives: Procedure: postoperatively transferral to ICU |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
in-hospital mortality, 30-day and 90-day mortality
Measured: up to 90 days
Secondary outcomes (9)
Incidence of a composite of all-cause death, re-operation and major postoperative complications within 24 hours post surgery
The primary outcome that will be measured is a composite of all-cause death, re-operation and major postoperative complications within 24 hours post surgery
Measured: within 24 hours postoperatively
The time of length of stay (LOS)
LOS in PACU or ICU
Measured: within 24 hours postoperatively
incidence of care escalation
patients in PACU is transferred to ICU within 24 hours rather than to floor
Measured: within 24 hours postoperatively
Incidence of major complications
Postoperative major complications, defined by International Classification of Diseases, Tenth Revision (ICD-10) diagnostic codes
Measured: 30 days postoperatively
The time of hospital length of stay (LOS)
hospital length of stay (LOS)
Measured: up to 30 days
medical cost
Any medical cost during hospital stay
Measured: up to 90 days]
Incidence of emergency department (ED) visits
Emergency department (ED) visits within 90 days of the index surgery
Measured: 90 days
Ventilation time
Ventilation time postoperatively
Measured: up 30 days
Anaesthetic resuscitation time
Anaesthetic resuscitation time postoperatively
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start1 Oct 2021 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 18,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, xiangming fang, First Affiliated Hospital of Zhejiang University
- Investigators
- Xiangming Fang, Professor, Principal investigator, First Affilated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05046925
- Sponsor's protocol ID
- PACU
- Status last verified
- Sep 2021
- First submitted
- 4 Sep 2021
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Share all the data after the first article was published on issue
Publications
International Surgical Outcomes Study group. Global patient outcomes after elective surgery: prospective cohort study in 27 low-, middle- and high-income countries. Br J Anaesth. 2016 Oct 31;117(5):601-609. doi: 10.1093/bja/aew316.
PubMed 27799174Weiser TG, Regenbogen SE, Thompson KD, Haynes AB, Lipsitz SR, Berry WR, Gawande AA. An estimation of the global volume of surgery: a modelling strategy based on available data. Lancet. 2008 Jul 12;372(9633):139-144. doi: 10.1016/S0140-6736(08)60878-8. Epub 2008 Jun 24.
PubMed 18582931Pastores SM, Kvetan V, Coopersmith CM, Farmer JC, Sessler C, Christman JW, D'Agostino R, Diaz-Gomez J, Gregg SR, Khan RA, Kapu AN, Masur H, Mehta G, Moore J, Oropello JM, Price K; Academic Leaders in Critical Care Medicine (ALCCM) Task Force of the Society of the Critical Care Medicine. Workforce, Workload, and Burnout Among Intensivists and Advanced Practice Providers: A Narrative Review. Crit Care Med. 2019 Apr;47(4):550-557. doi: 10.1097/CCM.0000000000003637.
PubMed 30688716Nates JL, Nunnally M, Kleinpell R, Blosser S, Goldner J, Birriel B, Fowler CS, Byrum D, Miles WS, Bailey H, Sprung CL. ICU Admission, Discharge, and Triage Guidelines: A Framework to Enhance Clinical Operations, Development of Institutional Policies, and Further Research. Crit Care Med. 2016 Aug;44(8):1553-602. doi: 10.1097/CCM.0000000000001856.
PubMed 27428118Loer SA. Anesthesiologists should bring in their expertise during the early postoperative period to improve surgical outcome. Curr Opin Anaesthesiol. 2018 Dec;31(6):713-715. doi: 10.1097/ACO.0000000000000663. No abstract available.
PubMed 30247164Lalani SB, Ali F, Kanji Z. Prolonged-stay patients in the PACU: a review of the literature. J Perianesth Nurs. 2013 Jun;28(3):151-5. doi: 10.1016/j.jopan.2012.06.009.
PubMed 23711311Kellner DB, Urman RD, Greenberg P, Brovman EY. Analysis of adverse outcomes in the post-anesthesia care unit based on anesthesia liability data. J Clin Anesth. 2018 Nov;50:48-56. doi: 10.1016/j.jclinane.2018.06.038. Epub 2018 Jun 29.
PubMed 29979999Belcher AW, Leung S, Cohen B, Yang D, Mascha EJ, Turan A, Saager L, Ruetzler K. Incidence of complications in the post-anesthesia care unit and associated healthcare utilization in patients undergoing non-cardiac surgery requiring neuromuscular blockade 2005-2013: A single center study. J Clin Anesth. 2017 Dec;43:33-38. doi: 10.1016/j.jclinane.2017.09.005. Epub 2017 Sep 30.
PubMed 28972924Probst S, Cech C, Haentschel D, Scholz M, Ender J. A specialized post anaesthetic care unit improves fast-track management in cardiac surgery: a prospective randomized trial. Crit Care. 2014 Aug 15;18(4):468. doi: 10.1186/s13054-014-0468-2.
PubMed 25123092Ender J, Borger MA, Scholz M, Funkat AK, Anwar N, Sommer M, Mohr FW, Fassl J. Cardiac surgery fast-track treatment in a postanesthetic care unit: six-month results of the Leipzig fast-track concept. Anesthesiology. 2008 Jul;109(1):61-6. doi: 10.1097/ALN.0b013e31817881b3.
PubMed 18580173Kastrup M, Seeling M, Barthel S, Bloch A, le Claire M, Spies C, Scheller M, Braun J. Effects of intensivist coverage in a post-anaesthesia care unit on surgical patients' case mix and characteristics of the intensive care unit. Crit Care. 2012 Jul 18;16(4):R126. doi: 10.1186/cc11428.
PubMed 22809294Duke GJ. Metropolitan audit of appropriate referrals refused admission to intensive care. Anaesth Intensive Care. 2004 Oct;32(5):702-6. doi: 10.1177/0310057X0403200518.
PubMed 15535499
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PACU or ICU for Postoperative Care After Major Thoracic and Abdominal Surgery：a Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05046925
- Acronym / sponsor ID
- PACU
- Conditions
- Anesthesia, Surgery--Complications
- Keywords
- Post-anesthetic care unit, Intensive care unit, Major surgery, postoperative complications, mortality, safety, efficacy, Postoperative care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 18,000 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 16 Sep 2021 (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.
The aim of this study is to demonstrate the efficacy and safety of a specialised post-anaesthetic care unit (PACU) to a conventional intensive care unit (ICU) in adult patients after major thoracic and abdominal surgery. A better understanding of PACU for postoperative care is likely to reduce mortality and postoperative complications.
Detailed description
With the continuous progress of surgical techniques, the number of major thoracic and abdominal surgeries is also increasing. Although intensive monitoring and initiative treatment benefit patients undergoing major surgery, there is also an increasing demand for intensive care in hospitals, which can lead to capacity limitations in the intensive care unit (ICU). In addition, there is emerging opinion that many patients after major thoracic and abdominal surgery do not require ICU care postoperatively to be provided safe and appropriate care. For hospitals and their staff the challenge is to optimize clinical processes and to optimize the effectiveness of treatment in regard to patient's outcome. Studying patient postoperative care following major thoracic and abdominal surgery exposes many opportunities to the improvement of patient safety, tailor the intensive care resource allocation and consider the costs and benefits of the options.
Postoperative mortality and morbidity remain major challenges, and most of these complications develop during the early postoperative period when patients have left the recovery room. Thus improving the care that patients receive once complications have occurred is crucial for reducing mortality. The post-anesthetic care unit (PACU) provides general to intensive care to immediate postsurgical patients. Patients with major thoracic and abdominal surgery surgeries are often kept in PACU until their condition is stabilized before shifting them to their designated wards or ICU[9]. Ender et al. and Probs et al. showed that treatment in a specialized PACU rather than an ICU, after cardiac surgery leads to earlier extubation, decreased ICU length of stay (LOS) and quicker discharge of hospital without compromising patient safety. Kastrup et al. described, introduction of a PACU staffed with intensivist coverage around the clock might shorten the hospital LOS and more patients can be treated in the same time, due to a better use of resources. Some other study described the transferral to a PACU as an unfavourable option, since equipment, expertise and staffing levels in the PACU are different from the ICU.
The possible solution to this problem might be the inclusion of the PACU in the process of distribution of patients to the different levels of intensive care for ensuring the timely recognition and effective management of postoperative complications in patients after major thoracic and abdominal surgery. The most challenges are to identify those candidates who can be monitored PACU within 24 hours postoperatively, rather than in ICU, and implement change in care paradigms safely.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 24-hour PACU group | – | Procedure: postoperatively transferral to PACUclosely monitor in post-anesthetic unit (PACU) and the stay time is less than 24 hours, then patients can be discharged to floor |
| 24-hour ICU group | – | Procedure: postoperatively transferral to ICUclosely monitor in intensive care unit (ICU) and the stay time is less than 24 hours, even patients die within 24 hours in ICU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing major thoracic and abdominal surgery between September, 2021 and September, 2023 will be included in this study
Key inclusion criteria (4 listed)
- Aged 18 years and older
- Undergoing major thoracic and abdominal surgery
- Postoperative hospital stay expected to be at least one night
- Patients requiring less than 24 hour stay in PACU or ICU
Key exclusion criteria (5 listed)
- Patients aged less than 18 years
- Not receive major thoracic and abdominal surgery
- Stay in ICU is over 24 hours
- Hospital stay is less than 24 hours
- Patient not signing the informed consensus
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 |
|---|---|---|
| postoperatively transferral to PACUAlso: 24-hour PACU grouppatients undergoing major thoracic and abdominal surgery will be transferred to PACU for postoperative care. | Procedure or surgery | 24-hour PACU group |
| postoperatively transferral to ICUAlso: 24-hour ICU grouppatients undergoing major thoracic and abdominal surgery will be transferred to ICU for postoperative care. | Procedure or surgery | 24-hour ICU group |
Primary outcome
mortality
Time frame: up to 90 days
in-hospital mortality, 30-day and 90-day mortality
9 secondary outcomes
Incidence of a composite of all-cause death, re-operation and major postoperative complications within 24 hours post surgery
Time frame: within 24 hours postoperatively
The time of length of stay (LOS)
Time frame: within 24 hours postoperatively
incidence of care escalation
Time frame: within 24 hours postoperatively
Incidence of major complications
Time frame: 30 days postoperatively
The time of hospital length of stay (LOS)
Time frame: up to 30 days
medical cost
Time frame: up to 90 days]
Incidence of emergency department (ED) visits
Time frame: 90 days
Ventilation time
Time frame: up 30 days
Anaesthetic resuscitation time
Time frame: Up to 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Results publication: PubMed 27799174International Surgical Outcomes Study group. Global patient outcomes after elective surgery: prospective cohort study in 27 low-, middle- and high-income countries. Br J Anaesth. 2016 Oct 31;117(5):601-609. doi: 10.1093/bja/aew316.
- Results publication: PubMed 18582931Weiser TG, Regenbogen SE, Thompson KD, Haynes AB, Lipsitz SR, Berry WR, Gawande AA. An estimation of the global volume of surgery: a modelling strategy based on available data. Lancet. 2008 Jul 12;372(9633):139-144. doi: 10.1016/S0140-6736(08)60878-8. Epub 2008 Jun 24.
- Results publication: PubMed 30688716Pastores SM, Kvetan V, Coopersmith CM, Farmer JC, Sessler C, Christman JW, D'Agostino R, Diaz-Gomez J, Gregg SR, Khan RA, Kapu AN, Masur H, Mehta G, Moore J, Oropello JM, Price K; Academic Leaders in Critical Care Medicine (ALCCM) Task Force of the Society of the Critical Care Medicine. Workforce, Workload, and Burnout Among Intensivists and Advanced Practice Providers: A Narrative Review. Crit Care Med. 2019 Apr;47(4):550-557. doi: 10.1097/CCM.0000000000003637.
- Results publication: PubMed 27428118Nates JL, Nunnally M, Kleinpell R, Blosser S, Goldner J, Birriel B, Fowler CS, Byrum D, Miles WS, Bailey H, Sprung CL. ICU Admission, Discharge, and Triage Guidelines: A Framework to Enhance Clinical Operations, Development of Institutional Policies, and Further Research. Crit Care Med. 2016 Aug;44(8):1553-602. doi: 10.1097/CCM.0000000000001856.
- Results publication: PubMed 30247164Loer SA. Anesthesiologists should bring in their expertise during the early postoperative period to improve surgical outcome. Curr Opin Anaesthesiol. 2018 Dec;31(6):713-715. doi: 10.1097/ACO.0000000000000663. No abstract available.
- Results publication: PubMed 23711311Lalani SB, Ali F, Kanji Z. Prolonged-stay patients in the PACU: a review of the literature. J Perianesth Nurs. 2013 Jun;28(3):151-5. doi: 10.1016/j.jopan.2012.06.009.
- Results publication: PubMed 29979999Kellner DB, Urman RD, Greenberg P, Brovman EY. Analysis of adverse outcomes in the post-anesthesia care unit based on anesthesia liability data. J Clin Anesth. 2018 Nov;50:48-56. doi: 10.1016/j.jclinane.2018.06.038. Epub 2018 Jun 29.
- Results publication: PubMed 28972924Belcher AW, Leung S, Cohen B, Yang D, Mascha EJ, Turan A, Saager L, Ruetzler K. Incidence of complications in the post-anesthesia care unit and associated healthcare utilization in patients undergoing non-cardiac surgery requiring neuromuscular blockade 2005-2013: A single center study. J Clin Anesth. 2017 Dec;43:33-38. doi: 10.1016/j.jclinane.2017.09.005. Epub 2017 Sep 30.
- Results publication: PubMed 25123092Probst S, Cech C, Haentschel D, Scholz M, Ender J. A specialized post anaesthetic care unit improves fast-track management in cardiac surgery: a prospective randomized trial. Crit Care. 2014 Aug 15;18(4):468. doi: 10.1186/s13054-014-0468-2.
- Results publication: PubMed 18580173Ender J, Borger MA, Scholz M, Funkat AK, Anwar N, Sommer M, Mohr FW, Fassl J. Cardiac surgery fast-track treatment in a postanesthetic care unit: six-month results of the Leipzig fast-track concept. Anesthesiology. 2008 Jul;109(1):61-6. doi: 10.1097/ALN.0b013e31817881b3.
- Results publication: PubMed 22809294Kastrup M, Seeling M, Barthel S, Bloch A, le Claire M, Spies C, Scheller M, Braun J. Effects of intensivist coverage in a post-anaesthesia care unit on surgical patients' case mix and characteristics of the intensive care unit. Crit Care. 2012 Jul 18;16(4):R126. doi: 10.1186/cc11428.
- Results publication: PubMed 15535499Duke GJ. Metropolitan audit of appropriate referrals refused admission to intensive care. Anaesth Intensive Care. 2004 Oct;32(5):702-6. doi: 10.1177/0310057X0403200518.
- Individual participant dataSharing planned: Undecided. Share all the data after the first article was published on issue
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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.
Xiangming Fang, Professor principal investigator
First Affilated Hospital of Zhejiang University
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 Anesthesia and Surgery--Complications, run by First Affiliated Hospital of Zhejiang University 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 4 inclusion and 5 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 16 Sep 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hui Ye, Doctor (8615267048716, 0007--007@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: up to 90 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 NCT05046925, which also lists 12 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 16 Sep 2021.