Heart DiseasesPhase 4NCT02349152
Remifentanil and Glycemic Response in Cardiac Surgery
A Phase 4 study testing Remifentanil and Fentanyl in people with Heart Diseases and Hyperglycemia, run by Kathirvel Subramaniam at 1 site in United States.
Trial summary
This study evaluates the effect of using remifentanil during cardiopulmonary bypass surgery to supress the hyperglycemic response in perioperative period. Half of the participants will receive continuous intravenous remifentanil during surgery, while the other half will receive intermittent intravenous fentanyl during… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Diseases, Hyperglycemia
- What is being tested?
- Remifentanil and Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Dec 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Open cardiac surgery through sternotomy approach (coronary artery bypass, valve surgery, and any other open heart surgeries)
- Surgery with use of cardiopulmonary bypass
- Patients over 18 years of age
- Both female and male genders
- All races
Who cannot join
- Minimally invasive heart surgery through thoracotomy approach
- Patients receiving regional analgesia such as intrathecal morphine
- Patients undergoing procedures under deep hypothermic circulatory arrest
- Patients with active infections such as acute infective endocarditis
- Emergency surgery
- Patients undergoing transplantations and ventricular assist device insertion
Show all 12Show fewer
- Patients on any mechanical circulatory support preoperatively
- Patient's refusal
- Allergy to remifentanil
- Positive pregnancy test
- Morbid obesity
- End stage liver and kidney disease
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213
About this study
Official title: The Effect of Intraoperative Continuous Remifentanil Infusion on Glycemic Response and Variability in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass: A Prospective, Randomized, Open Label Clinical Trial
This study evaluates the effect of using remifentanil during cardiopulmonary bypass surgery to supress the hyperglycemic response in perioperative period. Half of the participants will receive continuous intravenous remifentanil during surgery, while the other half will receive intermittent intravenous fentanyl during surgery. Intermittent intravenous fentanyl administration is this institution's standard of care.
Read the detailed description
Stress-induced hyperglycemia is a well-known phenomena that occurs during cardiopulmonary bypass surgery. Hyperglycemia increases the incidence of major adverse events and mortality in patients undergoing cardiac surgery.
Remifentanil, an ultra-short acting opioid analgesic, has been shown to reduce the stress response to cardiopulmonary bypass when compared to intermittent fentanyl and inhalation anesthesia. This in turn, will reduce the occurence of perioperative hyperglycemia, glycemic variability and insulin requirements in patients undergoing cardiac surgery.
NOTE;
Primary Outcome changed on 06/15/2015-Change Approved by University of Pittsburgh IRB on 06/22/2015- First patient enrolled January 2016.
Primary outcome measure; Percentage of patients with two or more than two intraoperative blood glucose levels more than 180 mg% in both groups will be estimated and the difference in this parameter between the two groups will form the primary outcome measure of this study.
- Conditions
- Heart Diseases, Hyperglycemia
- Being tested
- Remifentanil, Fentanyl
- Keywords
- Cardiopulmonary bypass, Heart surgery
- Medical subject headings
- Heart Diseases, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
Also called Ultiva
Subjects in the experimental group will receive remifentanil infusion 0.1-0.4ug/kg/minute before induction of anesthesia and continued until skin closure. During cardiopulmonary bypass, remifentanil infusion will be increased to 0.5-1 ug/kg/min as hemodynamically tolerated.
FentanylDrug
Subjects in the control group will initially receive intermittent boluses of Fentanyl in the range of 50-250 ug. Additional fentanyl can be given titrated to hemodynamic parameters throughout surgery.
| Study group | Role | What they receive |
|---|---|---|
| Remifentanil group | Experimental | Half of subjects enrolled will be randomized to the remifentanil group Receives: Drug: Remifentanil |
| Fentanyl group | Active comparator | Half of subjects enrolled will be randomized to the fentanyl group Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Glucose Values (More Than One ) > 180 mg%
Percentage of patients with two or more intraoperative blood glucose levels greater than 180 mg/dl. Percentage in both groups will be estimated, then the difference in this statistic will form the primary outcome measure of this study.
(Primary Outcome changed on 06/15/2015-Change Approved by University of Pittsburgh IRB on 06/22/2015- First patient enrolled January 2016)
Measured: Intraoperative period
Secondary outcomes (15)
Insulin Requirement
Average dose of insulin (Units/ml) calculated for each group in the intraoperative period
Measured: Intraoperative period; Induction to end of surgery
Number of Blood Glucose Values > 180 mg%
Blood glucose values that exceed 180 mg% will be counted
Measured: Intraoperative period, Induction to end of surgery
Mean, Peak and Trough Intraoperative Blood Glucose (mg/dl)
Blood glucose measured every hour
Measured: Intraoperative period; Induction to end of surgery
Postoperative Blood Glucose
Mean and peak blood glucose levels postoperatively
Measured: From ICU Admission (After Surgery) Until 24 hours postoperatively
Total Postoperative Regular Insulin
Total units of regular insulin required post-operatively
Measured: From ICU Admission (After Surgery) Until 24 hours postoperatively
Intraoperative Pre-cardiopulmonary Bypass Hemodynamic Stability
Blood pressure (systolic, diastolic and mean), Heart rate every 5 minutes from induction of anesthesia till systemic heparinization before cardiopulmonary bypass
Measured: induction of anesthesia till systemic heparinization before cardiopulmonary bypass
Stress Hormone Levels-Cortisol (µg/dl)
Serum cortisol levels (measured as µg/dl) taken at: Prebypass, cardiopulmonary bypass (2 samples: at start of bypass and end of bypass), postbypass, ICU 8 hours postoperative period
Measured: Perioperative period (Intraoperatively and 8 hours postoperatively)
Inflammatory Mediator Levels, Interleukin-1b, Interleukin 6 and Tumor Necrosis Factor (TNF) (pg/ml)
Inflammatory mediator levels, Interleukin-1b (IL-1b), Interleukin 6 (IL-6) and Tumor Necrosis Factor Alpha (TNFa) (all measured in pg/ml) taken at: Prebypass, cardiopulmonary bypass (2 samples:30 min start of bypass (CPB-30) and end of bypass (CPB-END), postbypass, ICU 8 hours postoperative period
Measured: Perioperative period (Intraoperatively and 8 hours postoperatively)
Stress Hormone Levels-ACTH, GH, Glucagon (pg/ml)
Adreno-corticotrophic hormone (ACTH), Growth Hormone (GH) and Glucagon (measured as pg/ml) taken at: Prebypass, cardiopulmonary bypass (2 samples: 30 mins after start of bypass (CPB 30) and end of bypass (CPB END), post-bypass and ICU 8 hours postoperative period
Measured: Perioperative period (Intraoperatively and 8 hours postoperatively)
Society of Thoracic Surgery Patient Outcomes
Postoperative outcomes collected from the Society of Thoracic Surgery (STS) database. 30 day Mortality (outcome 1) and 30 day Readmission (outcome 2) cerebral vascular accident(outcome 3), prolonged mechanical ventilation (outcome 4), renal failure (outcome 5), atrial fibrillation (outcome 6), cardiac arrest (outcome 7)
Measured: 30 day outcomes
Postoperative Pain
Pain scores; Every day 6 hour for 48 hours postoperative period
Measured: Every day 6 hour for 48 hours postoperative period
Emergence From Anesthesia
Time to extubation after completion of surgery in the operating room and intensive care unit
Measured: Immediate postoperative period until 30 days post-operatively
Wound Hyperalgesia
Von frey hair objective testing
Measured: 96 hours postoperatively
Development of Chronic Pain
Telephonic call Numeric pain scale; Scale is 0-10, with 10 being the highest pain.
Measured: 1, 3, 6 and 12 months after discharge from the hospital
Glycemic Variability
Coefficient of variation in blood glucose levels. Denotes how large the fluctuations in blood glucose are. Higher numbers indicate increased variation.
Measured: From the start of induction till 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study startJan 2016
- Primary completionDec 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Heart DiseasesStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kathirvel Subramaniam
- Sponsor type
- University, hospital or other
- Collaborators
- Mylan Inc.
- Responsible party
- Sponsor-investigator, Kathirvel Subramaniam, University of Pittsburgh
- Investigators
- Kathrivel Subramaniam, MD, Principal investigator, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02349152
- Sponsor's protocol ID
- PRO14110258
- Status last verified
- Apr 2020
- First submitted
- 13 Jan 2015
- Last updated
- 21 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Doenst T, Wijeysundera D, Karkouti K, Zechner C, Maganti M, Rao V, Borger MA. Hyperglycemia during cardiopulmonary bypass is an independent risk factor for mortality in patients undergoing cardiac surgery. J Thorac Cardiovasc Surg. 2005 Oct;130(4):1144. doi: 10.1016/j.jtcvs.2005.05.049.
PubMed 16214532Ihn CH, Joo JD, Choi JW, Kim DW, Jeon YS, Kim YS, Jung HS, Kwon SY. Comparison of stress hormone response, interleukin-6 and anaesthetic characteristics of two anaesthetic techniques: volatile induction and maintenance of anaesthesia using sevoflurane versus total intravenous anaesthesia using propofol and remifentanil. J Int Med Res. 2009 Nov-Dec;37(6):1760-71. doi: 10.1177/147323000903700612.
PubMed 20146874Subramaniam B, Lerner A, Novack V, Khabbaz K, Paryente-Wiesmann M, Hess P, Talmor D. Increased glycemic variability in patients with elevated preoperative HbA1C predicts adverse outcomes following coronary artery bypass grafting surgery. Anesth Analg. 2014 Feb;118(2):277-287. doi: 10.1213/ANE.0000000000000100.
PubMed 24445629Shinoda T, Murakami W, Takamichi Y, Iizuka H, Tanaka M, Kuwasako Y. Effect of remifentanil infusion rate on stress response in orthopedic surgery using a tourniquet application. BMC Anesthesiol. 2013 Jul 10;13:14. doi: 10.1186/1471-2253-13-14. eCollection 2013.
PubMed 23837943Cok OY, Ozkose Z, Pasaoglu H, Yardim S. Glucose response during craniotomy: propofol-remifentanil versus isoflurane-remifentanil. Minerva Anestesiol. 2011 Dec;77(12):1141-8. Epub 2011 May 20.
PubMed 21602751Lazar HL, McDonnell M, Chipkin SR, Furnary AP, Engelman RM, Sadhu AR, Bridges CR, Haan CK, Svedjeholm R, Taegtmeyer H, Shemin RJ; Society of Thoracic Surgeons Blood Glucose Guideline Task Force. The Society of Thoracic Surgeons practice guideline series: Blood glucose management during adult cardiac surgery. Ann Thorac Surg. 2009 Feb;87(2):663-9. doi: 10.1016/j.athoracsur.2008.11.011. No abstract available.
PubMed 19161815Subramaniam K, Sciortino C, Ruppert K, Monroe A, Esper S, Boisen M, Marquez J, Hayanga H, Badhwar V. Remifentanil and perioperative glycaemic response in cardiac surgery: an open-label randomised trial. Br J Anaesth. 2020 Jun;124(6):684-692. doi: 10.1016/j.bja.2020.01.028. Epub 2020 Apr 2.
PubMed 32247539
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intraoperative Continuous Remifentanil Infusion on Glycemic Response and Variability in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass: A Prospective, Randomized, Open Label Clinical Trial
- ClinicalTrials.gov ID
- NCT02349152
- Acronym / sponsor ID
- PRO14110258
- Conditions
- Heart Diseases, Hyperglycemia
- Keywords
- Cardiopulmonary bypass, Heart surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Kathirvel SubramaniamUniversity, hospital or other
- Collaborators
- Mylan Inc.
- Study start
- Jan 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 28 Jan 2015 (estimated)
- Results
- Posted 14 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the effect of using remifentanil during cardiopulmonary bypass surgery to supress the hyperglycemic response in perioperative period. Half of the participants will receive continuous intravenous remifentanil during surgery, while the other half will receive intermittent intravenous fentanyl during surgery. Intermittent intravenous fentanyl administration is this institution's standard of care.
Detailed description
Stress-induced hyperglycemia is a well-known phenomena that occurs during cardiopulmonary bypass surgery. Hyperglycemia increases the incidence of major adverse events and mortality in patients undergoing cardiac surgery.
Remifentanil, an ultra-short acting opioid analgesic, has been shown to reduce the stress response to cardiopulmonary bypass when compared to intermittent fentanyl and inhalation anesthesia. This in turn, will reduce the occurence of perioperative hyperglycemia, glycemic variability and insulin requirements in patients undergoing cardiac surgery.
NOTE;
Primary Outcome changed on 06/15/2015-Change Approved by University of Pittsburgh IRB on 06/22/2015- First patient enrolled January 2016.
Primary outcome measure; Percentage of patients with two or more than two intraoperative blood glucose levels more than 180 mg% in both groups will be estimated and the difference in this parameter between the two groups will form the primary outcome measure of this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remifentanil group | Experimental | Drug: RemifentanilHalf of subjects enrolled will be randomized to the remifentanil group |
| Fentanyl group | Active comparator | Drug: FentanylHalf of subjects enrolled will be randomized to the fentanyl group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Open cardiac surgery through sternotomy approach (coronary artery bypass, valve surgery, and any other open heart surgeries)
- Surgery with use of cardiopulmonary bypass
- Patients over 18 years of age
- Both female and male genders
- All races
Key exclusion criteria (12 listed)
- Minimally invasive heart surgery through thoracotomy approach
- Patients receiving regional analgesia such as intrathecal morphine
- Patients undergoing procedures under deep hypothermic circulatory arrest
- Patients with active infections such as acute infective endocarditis
- Emergency surgery
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 |
|---|---|---|
| RemifentanilAlso: UltivaSubjects in the experimental group will receive remifentanil infusion 0.1-0.4ug/kg/minute before induction of anesthesia and continued until skin closure. During cardiopulmonary bypass, remifentanil infusion will be increased to 0.5-1 ug/kg/min as hemodynamically tolerated. | Drug | Remifentanil group |
| FentanylSubjects in the control group will initially receive intermittent boluses of Fentanyl in the range of 50-250 ug. Additional fentanyl can be given titrated to hemodynamic parameters throughout surgery. | Drug | Fentanyl group |
Primary outcome
Blood Glucose Values (More Than One ) > 180 mg%
Time frame: Intraoperative period
Percentage of patients with two or more intraoperative blood glucose levels greater than 180 mg/dl. Percentage in both groups will be estimated, then the difference in this statistic will form the primary outcome measure of this study. (Primary Outcome changed on 06/15/2015-Change Approved by University of Pittsburgh IRB on 06/22/2015- First patient enrolled January 2016)
15 secondary outcomes
Insulin Requirement
Time frame: Intraoperative period; Induction to end of surgery
Number of Blood Glucose Values > 180 mg%
Time frame: Intraoperative period, Induction to end of surgery
Mean, Peak and Trough Intraoperative Blood Glucose (mg/dl)
Time frame: Intraoperative period; Induction to end of surgery
Postoperative Blood Glucose
Time frame: From ICU Admission (After Surgery) Until 24 hours postoperatively
Total Postoperative Regular Insulin
Time frame: From ICU Admission (After Surgery) Until 24 hours postoperatively
Intraoperative Pre-cardiopulmonary Bypass Hemodynamic Stability
Time frame: induction of anesthesia till systemic heparinization before cardiopulmonary bypass
Stress Hormone Levels-Cortisol (µg/dl)
Time frame: Perioperative period (Intraoperatively and 8 hours postoperatively)
Inflammatory Mediator Levels, Interleukin-1b, Interleukin 6 and Tumor Necrosis Factor (TNF) (pg/ml)
Time frame: Perioperative period (Intraoperatively and 8 hours postoperatively)
Stress Hormone Levels-ACTH, GH, Glucagon (pg/ml)
Time frame: Perioperative period (Intraoperatively and 8 hours postoperatively)
Society of Thoracic Surgery Patient Outcomes
Time frame: 30 day outcomes
Postoperative Pain
Time frame: Every day 6 hour for 48 hours postoperative period
Emergence From Anesthesia
Time frame: Immediate postoperative period until 30 days post-operatively
Wound Hyperalgesia
Time frame: 96 hours postoperatively
Development of Chronic Pain
Time frame: 1, 3, 6 and 12 months after discharge from the hospital
Glycemic Variability
Time frame: From the start of induction till 24 hours postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16214532Doenst T, Wijeysundera D, Karkouti K, Zechner C, Maganti M, Rao V, Borger MA. Hyperglycemia during cardiopulmonary bypass is an independent risk factor for mortality in patients undergoing cardiac surgery. J Thorac Cardiovasc Surg. 2005 Oct;130(4):1144. doi: 10.1016/j.jtcvs.2005.05.049.
- Background: PubMed 20146874Ihn CH, Joo JD, Choi JW, Kim DW, Jeon YS, Kim YS, Jung HS, Kwon SY. Comparison of stress hormone response, interleukin-6 and anaesthetic characteristics of two anaesthetic techniques: volatile induction and maintenance of anaesthesia using sevoflurane versus total intravenous anaesthesia using propofol and remifentanil. J Int Med Res. 2009 Nov-Dec;37(6):1760-71. doi: 10.1177/147323000903700612.
- Background: PubMed 24445629Subramaniam B, Lerner A, Novack V, Khabbaz K, Paryente-Wiesmann M, Hess P, Talmor D. Increased glycemic variability in patients with elevated preoperative HbA1C predicts adverse outcomes following coronary artery bypass grafting surgery. Anesth Analg. 2014 Feb;118(2):277-287. doi: 10.1213/ANE.0000000000000100.
- Background: PubMed 23837943Shinoda T, Murakami W, Takamichi Y, Iizuka H, Tanaka M, Kuwasako Y. Effect of remifentanil infusion rate on stress response in orthopedic surgery using a tourniquet application. BMC Anesthesiol. 2013 Jul 10;13:14. doi: 10.1186/1471-2253-13-14. eCollection 2013.
- Background: PubMed 21602751Cok OY, Ozkose Z, Pasaoglu H, Yardim S. Glucose response during craniotomy: propofol-remifentanil versus isoflurane-remifentanil. Minerva Anestesiol. 2011 Dec;77(12):1141-8. Epub 2011 May 20.
- Background: PubMed 19161815Lazar HL, McDonnell M, Chipkin SR, Furnary AP, Engelman RM, Sadhu AR, Bridges CR, Haan CK, Svedjeholm R, Taegtmeyer H, Shemin RJ; Society of Thoracic Surgeons Blood Glucose Guideline Task Force. The Society of Thoracic Surgeons practice guideline series: Blood glucose management during adult cardiac surgery. Ann Thorac Surg. 2009 Feb;87(2):663-9. doi: 10.1016/j.athoracsur.2008.11.011. No abstract available.
- Derived from this study: PubMed 32247539Subramaniam K, Sciortino C, Ruppert K, Monroe A, Esper S, Boisen M, Marquez J, Hayanga H, Badhwar V. Remifentanil and perioperative glycaemic response in cardiac surgery: an open-label randomised trial. Br J Anaesth. 2020 Jun;124(6):684-692. doi: 10.1016/j.bja.2020.01.028. Epub 2020 Apr 2.
- Individual participant dataSharing planned: No
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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.
Kathrivel Subramaniam, MD principal investigator
University of Pittsburgh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Remifentanil and Fentanyl in people with Heart Diseases and Hyperglycemia, run by Kathirvel Subramaniam 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 5 inclusion and 12 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 21 Apr 2020. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Blood Glucose Values (More Than One ) > 180 mg% (time frame: Intraoperative period). 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 NCT02349152, which also lists 7 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 21 Apr 2020.