Myocardial InfarctionNCT04382313

Effect of Hydration Guided by Vigileo on the Prevention of CIN After PCI for Patients With AMI

A study testing the adequate hydration group guided by Vigileo in people with Myocardial Infarction and Contrast-induced Nephropathy, run by Chinese PLA General Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

In this study, Vigileo is used to guide hydration adjustment, and SCr is used to estimate renal function. The aim of the study is to investigate the preventive effect of adequate hydration guided by Vigileo on contrast induced nephropathy in patients with acute myocardial infarction who undergo PCI. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Myocardial Infarction, Contrast-induced Nephropathy
What is being tested?: the adequate hydration group guided by Vigileo
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 344 participants
Where: 1 siteChina
Study dates: 10 Jul 2020to 21 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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Clearly diagnosed STEMI or NSTEMI patients:
Patients aged 18-80 years
Patients are scheduled to undergo emergency percutaneous coronary interventions
Estimated glomerular filtration rate eGFR <120ml / min (according to MDRD formula)
Sign the informed consent to join the group.

Who cannot join

Patients with mechanical complications
Patients with cardiogenic shock
Patients with aortic dissection
Patients who have malignant tumors or short-term progressive diseases that researchers believe improper to be included in the group
Hemodialysis-dependent patients with end-stage renal failure
Patients who had a history of exposure to radioactive contrast media within 1 week before or 72 hours after direct PCI
Patients who are allergic to radioactive contrast agents
Patients diagnosed with right ventricular myocardial infarction with hypotension (defined as systolic blood pressure ≤90 mmHg) on admission.

Trial locations and contacts

1 site in 1 country.

China1 site

Chinese People's Liberation Army General Hospital
Beijing, Beijing Municipality, 100853

Other trials in China

About this study

Official title: Effect of Hydration Guided by Vigileo on the Prevention of Contrast Induced Nephropathy After Emergency PCI for Patients With Acute Myocardial Infarction

Read the detailed description

This study was conducted in patients with acute myocardial infarction who undergo emergency PCI in Chinese PLA General Hospital. The patients were randomly divided into two groups: the adequate hydration group guided by Vigileo and control group. For the adequate hydration group guided by Vigileo, Vigileo equipment is used to perform hemodynamic monitoring through the femoral or radial arteries to obtain relevant hemodynamic parameters (CO, SV, SVV), and the fluid-rehydration velocity of normal saline is adjusted according to the hemodynamic parameters, and the hydration also lasts 24 hours after operation. For the control group, the routine hydration regimen is adopted, perioperative saline ≤500 ml hydration. The changes of renal function (serum creatinine, serum cystatin), symptoms and signs of cardiac insufficiency during perioperative period and cardiac objective indexes are observed. The incidence of postoperative acute pulmonary edema is recorded, and the major cardiovascular events and hemodialysis events are followed up for 6 months. By comparing the perioperative indexes of heart and kidney function between the intervention group and the control group, the preventive effect of adequate hydration guided by Vigileo on contrast induced nephropathy after PCI was clarified.

Conditions: Myocardial Infarction, Contrast-induced Nephropathy
Being tested: the adequate hydration group guided by Vigileo
Keywords: Hydration, Contrast-induced Nephropathy, contrast induced acute kidney injury
Medical subject headings: Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

the adequate hydration group guided by VigileoProcedure or surgery
If the patient is mechanically ventilated, the following scheme is adopted: if SVV≤10%, then adjust the rehydration speed to 1 ml/kg/h; if 10%<SVV<15%, then adjust the rehydration speed to 2 ml/kg/h; if SVV≥15%, then adjust the rehydration speed to 3 ml/kg/h. The hydration lasts 24 hours after operation, and the rehydration speed is changed according to the SVV. If the patient does not use mechanical ventilation, the following scheme is adopted: 250ml normal saline is administered within 10 minutes after direct PCI, and the rehydration volume changes to 125ml in patients with mild-to-moderate congestive heart failure. If the increment of SV≥15%, then adjust the rehydration speed to 3 ml/kg/h; if 10%≤the increment of SV<15%, then adjust the rehydration speed to 2 ml/kg/h; if the increment of SV<10%, then adjust the rehydration speed to 1 ml/kg/h. Reassessed every 1 hour until SV is stable，and the hydration also lasts 24 hours after operation.

Study groups in NCT04382313
Study group	Role	What they receive
the adequate hydration group guided by Vigileo	Placebo comparator	The hydration speed is adjusted according to SVV or SV by Vigileo Receives: Procedure: the adequate hydration group guided by Vigileo
the control group	No intervention	The routine hydration regimen is adopted, perioperative saline ≤500 ml hydration

What is being measured

The primary outcome is the main question the study is designed to answer.

Contrast induced nephropathy
Contrast induced nephropathy is defined as serum creatinine values increased by 0.5 mg/dl or 25% relative to baseline absolute values after direct PCI within 48-72 hours.
Measured: 48-72 hours after PCI

Secondary outcomes (4)

The acute renal injury caused by contrast agent
The acute renal injury caused by contrast agent is defined as the serum creatinine value increased by 0.3 mg/dl than the baseline absolute value after direct PCI within 48 hours.
Measured: 48 hours after PCI
Persistent renal insufficiency
Persistent renal insufficiency is defined as at least 25% decrease compared with baseline in creatinine clearance 3 months after direct PCI.
Measured: 3 months after PCI
renal replacement therapy and/or death from acute renal failure
renal replacement therapy and/or death from acute renal failure
Measured: 6 months after PCI
Major adverse cardiac events
all-cause death, non-lethal acute myocardial infarction, revascularization
Measured: 6 months after PCI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jul 202021 Dec 2022

First posted11 May 2020
Study start10 Jul 2020
Primary completion30 May 2022
Study completion21 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (23)Papers the sponsor has linked to this study.
Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
More trials run by Chinese PLA General HospitalThe 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: Single blind
Who is masked: Outcomes assessor
Enrolment: 344 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04382313
Sponsor's protocol ID: sf2020-2-5012
Status last verified: Jan 2022
First submitted: 7 May 2020
Last updated: 4 Jan 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Mehran R, Aymong ED, Nikolsky E, Lasic Z, Iakovou I, Fahy M, Mintz GS, Lansky AJ, Moses JW, Stone GW, Leon MB, Dangas G. A simple risk score for prediction of contrast-induced nephropathy after percutaneous coronary intervention: development and initial validation. J Am Coll Cardiol. 2004 Oct 6;44(7):1393-9. doi: 10.1016/j.jacc.2004.06.068.
PubMed 15464318
From AM, Bartholmai BJ, Williams AW, Cha SS, McDonald FS. Mortality associated with nephropathy after radiographic contrast exposure. Mayo Clin Proc. 2008 Oct;83(10):1095-100. doi: 10.4065/83.10.1095.
PubMed 18828968
Sadeghi HM, Stone GW, Grines CL, Mehran R, Dixon SR, Lansky AJ, Fahy M, Cox DA, Garcia E, Tcheng JE, Griffin JJ, Stuckey TD, Turco M, Carroll JD. Impact of renal insufficiency in patients undergoing primary angioplasty for acute myocardial infarction. Circulation. 2003 Dec 2;108(22):2769-75. doi: 10.1161/01.CIR.0000103623.63687.21. Epub 2003 Nov 24.
PubMed 14638545
Marenzi G, Lauri G, Assanelli E, Campodonico J, De Metrio M, Marana I, Grazi M, Veglia F, Bartorelli AL. Contrast-induced nephropathy in patients undergoing primary angioplasty for acute myocardial infarction. J Am Coll Cardiol. 2004 Nov 2;44(9):1780-5. doi: 10.1016/j.jacc.2004.07.043.
PubMed 15519007
Caspi O, Habib M, Cohen Y, Kerner A, Roguin A, Abergel E, Boulos M, Kapeliovich MR, Beyar R, Nikolsky E, Aronson D. Acute Kidney Injury After Primary Angioplasty: Is Contrast-Induced Nephropathy the Culprit? J Am Heart Assoc. 2017 Jun 24;6(6):e005715. doi: 10.1161/JAHA.117.005715.
PubMed 28647690
Pyxaras SA, Sinagra G, Mangiacapra F, Perkan A, Di Serafino L, Vitrella G, Rakar S, De Vroey F, Santangelo S, Salvi A, Toth G, Bartunek J, De Bruyne B, Wijns W, Barbato E. Contrast-induced nephropathy in patients undergoing primary percutaneous coronary intervention without acute left ventricular ejection fraction impairment. Am J Cardiol. 2013 Mar 1;111(5):684-8. doi: 10.1016/j.amjcard.2012.11.018. Epub 2012 Dec 19.
PubMed 23261003
Brar SS, Aharonian V, Mansukhani P, Moore N, Shen AY, Jorgensen M, Dua A, Short L, Kane K. Haemodynamic-guided fluid administration for the prevention of contrast-induced acute kidney injury: the POSEIDON randomised controlled trial. Lancet. 2014 May 24;383(9931):1814-23. doi: 10.1016/S0140-6736(14)60689-9.
PubMed 24856027
Pannu N, Wiebe N, Tonelli M; Alberta Kidney Disease Network. Prophylaxis strategies for contrast-induced nephropathy. JAMA. 2006 Jun 21;295(23):2765-79. doi: 10.1001/jama.295.23.2765.
PubMed 16788132
Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS); European Association for Percutaneous Cardiovascular Interventions (EAPCI); Wijns W, Kolh P, Danchin N, Di Mario C, Falk V, Folliguet T, Garg S, Huber K, James S, Knuuti J, Lopez-Sendon J, Marco J, Menicanti L, Ostojic M, Piepoli MF, Pirlet C, Pomar JL, Reifart N, Ribichini FL, Schalij MJ, Sergeant P, Serruys PW, Silber S, Sousa Uva M, Taggart D. Guidelines on myocardial revascularization. Eur Heart J. 2010 Oct;31(20):2501-55. doi: 10.1093/eurheartj/ehq277. Epub 2010 Aug 29. No abstract available.
PubMed 20802248
Tumkur SM, Vu AT, Li LP, Pierchala L, Prasad PV. Evaluation of intra-renal oxygenation during water diuresis: a time-resolved study using BOLD MRI. Kidney Int. 2006 Jul;70(1):139-43. doi: 10.1038/sj.ki.5000347. Epub 2006 Mar 29.
PubMed 16572109
Epstein FH, Veves A, Prasad PV. Effect of diabetes on renal medullary oxygenation during water diuresis. Diabetes Care. 2002 Mar;25(3):575-8. doi: 10.2337/diacare.25.3.575.
PubMed 11874950
Briguori C, Condorelli G. Hydration in contrast-induced acute kidney injury. Lancet. 2014 May 24;383(9931):1786-8. doi: 10.1016/S0140-6736(14)60753-4. No abstract available.
PubMed 24856014
Bagai A, Armstrong PW, Stebbins A, Mahaffey KW, Hochman JS, Weaver WD, Patel MR, Granger CB, Lopes RD. Prognostic implications of left ventricular end-diastolic pressure during primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: Findings from the Assessment of Pexelizumab in Acute Myocardial Infarction study. Am Heart J. 2013 Nov;166(5):913-9. doi: 10.1016/j.ahj.2013.08.006. Epub 2013 Sep 24.
PubMed 24176448
Remmelink M, Sjauw KD, Henriques JP, Vis MM, van der Schaaf RJ, Koch KT, Tijssen JG, de Winter RJ, Piek JJ, Baan J Jr. Acute left ventricular dynamic effects of primary percutaneous coronary intervention from occlusion to reperfusion. J Am Coll Cardiol. 2009 Apr 28;53(17):1498-502. doi: 10.1016/j.jacc.2008.12.058.
PubMed 19389559
Satiroglu O, Cicek Y, Bostan M, Cetin M, Bozkurt E. Acute change in left ventricle end-diastolic pressure after primary percutaneous coronary intervention in patients with ST segment elevation myocardial infarction. Am Heart Hosp J. 2010 Winter;8(2):E86-90.
PubMed 21928186

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Hydration Guided by Vigileo on the Prevention of Contrast Induced Nephropathy After Emergency PCI for Patients With Acute Myocardial Infarction
ClinicalTrials.gov ID: NCT04382313
Acronym / sponsor ID: sf2020-2-5012
Conditions: Myocardial Infarction, Contrast-induced Nephropathy
Keywords: Hydration, Contrast-induced Nephropathy, contrast induced acute kidney injury
Study type: Interventional
Recruitment status: Completed
Enrolment: 344 participants (actual)
Lead sponsor: Chinese PLA General HospitalUniversity, hospital or other
Collaborators: Lu jiang hospital
Study start: 10 Jul 2020 (actual)
Primary completion: 30 May 2022 (actual)
Study completion: 21 Dec 2022 (actual)
First posted: 11 May 2020 (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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
the adequate hydration group guided by Vigileo	Placebo comparator	Procedure: the adequate hydration group guided by VigileoThe hydration speed is adjusted according to SVV or SV by Vigileo
the control group	No intervention	–The routine hydration regimen is adopted, perioperative saline ≤500 ml hydration

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Clearly diagnosed STEMI or NSTEMI patients:
Patients aged 18-80 years
Patients are scheduled to undergo emergency percutaneous coronary interventions
Estimated glomerular filtration rate eGFR <120ml / min (according to MDRD formula)
Sign the informed consent to join the group.

Key exclusion criteria (8 listed)

Patients with mechanical complications
Patients with cardiogenic shock
Patients with aortic dissection
Patients who have malignant tumors or short-term progressive diseases that researchers believe improper to be included in the group
Hemodialysis-dependent patients with end-stage renal failure

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
the adequate hydration group guided by VigileoIf the patient is mechanically ventilated, the following scheme is adopted: if SVV≤10%, then adjust the rehydration speed to 1 ml/kg/h; if 10%<SVV<15%, then adjust the rehydration speed to 2 ml/kg/h; if SVV≥15%, then adjust the rehydration speed to 3 ml/kg/h. The hydration lasts 24 hours after operation, and the rehydration speed is changed according to the SVV. If the patient does not use mechanical ventilation, the following scheme is adopted: 250ml normal saline is administered within 10 minutes after direct PCI, and the rehydration volume changes to 125ml in patients with mild-to-moderate congestive heart failure. If the increment of SV≥15%, then adjust the rehydration speed to 3 ml/kg/h; if 10%≤the increment of SV<15%, then adjust the rehydration speed to 2 ml/kg/h; if the increment of SV<10%, then adjust the rehydration speed to 1 ml/kg/h. Reassessed every 1 hour until SV is stable，and the hydration also lasts 24 hours after operation.	Procedure or surgery	the adequate hydration group guided by Vigileo

Primary outcome

Contrast induced nephropathy
Time frame: 48-72 hours after PCI
Contrast induced nephropathy is defined as serum creatinine values increased by 0.5 mg/dl or 25% relative to baseline absolute values after direct PCI within 48-72 hours.

4 secondary outcomes

The acute renal injury caused by contrast agent
Time frame: 48 hours after PCI
Persistent renal insufficiency
Time frame: 3 months after PCI
renal replacement therapy and/or death from acute renal failure
Time frame: 6 months after PCI
Major adverse cardiac events
Time frame: 6 months after PCI

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 4 Jan 2023.
Background: PubMed 15464318Mehran R, Aymong ED, Nikolsky E, Lasic Z, Iakovou I, Fahy M, Mintz GS, Lansky AJ, Moses JW, Stone GW, Leon MB, Dangas G. A simple risk score for prediction of contrast-induced nephropathy after percutaneous coronary intervention: development and initial validation. J Am Coll Cardiol. 2004 Oct 6;44(7):1393-9. doi: 10.1016/j.jacc.2004.06.068.
Background: PubMed 18828968From AM, Bartholmai BJ, Williams AW, Cha SS, McDonald FS. Mortality associated with nephropathy after radiographic contrast exposure. Mayo Clin Proc. 2008 Oct;83(10):1095-100. doi: 10.4065/83.10.1095.
Background: PubMed 14638545Sadeghi HM, Stone GW, Grines CL, Mehran R, Dixon SR, Lansky AJ, Fahy M, Cox DA, Garcia E, Tcheng JE, Griffin JJ, Stuckey TD, Turco M, Carroll JD. Impact of renal insufficiency in patients undergoing primary angioplasty for acute myocardial infarction. Circulation. 2003 Dec 2;108(22):2769-75. doi: 10.1161/01.CIR.0000103623.63687.21. Epub 2003 Nov 24.
Background: PubMed 15519007Marenzi G, Lauri G, Assanelli E, Campodonico J, De Metrio M, Marana I, Grazi M, Veglia F, Bartorelli AL. Contrast-induced nephropathy in patients undergoing primary angioplasty for acute myocardial infarction. J Am Coll Cardiol. 2004 Nov 2;44(9):1780-5. doi: 10.1016/j.jacc.2004.07.043.
Background: PubMed 28647690Caspi O, Habib M, Cohen Y, Kerner A, Roguin A, Abergel E, Boulos M, Kapeliovich MR, Beyar R, Nikolsky E, Aronson D. Acute Kidney Injury After Primary Angioplasty: Is Contrast-Induced Nephropathy the Culprit? J Am Heart Assoc. 2017 Jun 24;6(6):e005715. doi: 10.1161/JAHA.117.005715.
Background: PubMed 23261003Pyxaras SA, Sinagra G, Mangiacapra F, Perkan A, Di Serafino L, Vitrella G, Rakar S, De Vroey F, Santangelo S, Salvi A, Toth G, Bartunek J, De Bruyne B, Wijns W, Barbato E. Contrast-induced nephropathy in patients undergoing primary percutaneous coronary intervention without acute left ventricular ejection fraction impairment. Am J Cardiol. 2013 Mar 1;111(5):684-8. doi: 10.1016/j.amjcard.2012.11.018. Epub 2012 Dec 19.
Background: PubMed 24856027Brar SS, Aharonian V, Mansukhani P, Moore N, Shen AY, Jorgensen M, Dua A, Short L, Kane K. Haemodynamic-guided fluid administration for the prevention of contrast-induced acute kidney injury: the POSEIDON randomised controlled trial. Lancet. 2014 May 24;383(9931):1814-23. doi: 10.1016/S0140-6736(14)60689-9.
Background: PubMed 16788132Pannu N, Wiebe N, Tonelli M; Alberta Kidney Disease Network. Prophylaxis strategies for contrast-induced nephropathy. JAMA. 2006 Jun 21;295(23):2765-79. doi: 10.1001/jama.295.23.2765.
Background: PubMed 20802248Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS); European Association for Percutaneous Cardiovascular Interventions (EAPCI); Wijns W, Kolh P, Danchin N, Di Mario C, Falk V, Folliguet T, Garg S, Huber K, James S, Knuuti J, Lopez-Sendon J, Marco J, Menicanti L, Ostojic M, Piepoli MF, Pirlet C, Pomar JL, Reifart N, Ribichini FL, Schalij MJ, Sergeant P, Serruys PW, Silber S, Sousa Uva M, Taggart D. Guidelines on myocardial revascularization. Eur Heart J. 2010 Oct;31(20):2501-55. doi: 10.1093/eurheartj/ehq277. Epub 2010 Aug 29. No abstract available.
Background: PubMed 16572109Tumkur SM, Vu AT, Li LP, Pierchala L, Prasad PV. Evaluation of intra-renal oxygenation during water diuresis: a time-resolved study using BOLD MRI. Kidney Int. 2006 Jul;70(1):139-43. doi: 10.1038/sj.ki.5000347. Epub 2006 Mar 29.
Background: PubMed 11874950Epstein FH, Veves A, Prasad PV. Effect of diabetes on renal medullary oxygenation during water diuresis. Diabetes Care. 2002 Mar;25(3):575-8. doi: 10.2337/diacare.25.3.575.
Background: PubMed 24856014Briguori C, Condorelli G. Hydration in contrast-induced acute kidney injury. Lancet. 2014 May 24;383(9931):1786-8. doi: 10.1016/S0140-6736(14)60753-4. No abstract available.

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing the adequate hydration group guided by Vigileo in people with Myocardial Infarction and Contrast-induced Nephropathy, run by Chinese PLA General Hospital 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 5 inclusion and 8 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 4 Jan 2023. 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. Some participants in this study may receive a placebo. 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?

Contrast induced nephropathy (time frame: 48-72 hours after PCI). 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 NCT04382313, which also lists 23 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 4 Jan 2023.