Liver TransplantationNCT03474666
Glycemic Control and Surgical Site Infection Incidence Among Liver Transplantation Recipients
A study of Liver Transplantation and Surgical Wound Infection, run by Ramon Oliveira at 1 site in Brazil.
Trial summary
Context: The hyperglycemia is an important independent risk factor for the Surgical Site Infection (SSI) development among liver transplantation recipients. Objective: To evaluate the effects of an intensive postoperative protocol of blood glucose management on the surgical site infection incidence among liver… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation, Surgical Wound Infection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteBrazil
- Study dates
- 11 Mar 2018to 15 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recipients of LT whose allograft came from deceased donors
- Able to give informed consent personally or via a family member who has appropriate authorization to do so if patient unconscious.
- Blood glucose level over 130 mg/dL in the first 24 hours postoperatively
Who cannot join
- The patients that underwent any kind of surgery with or without prosthesis implant in the 30 days before the LT
- Recipients submitted to multiple organ transplantation
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Santa Casa de São José dos Campos
São José dos Campos, São Paulo, 12210110
About this study
Official title: Postoperative Glycemic Control and the Surgical Site Infection Incidence Among Liver Transplantation Recipients: Randomized Clinical Trial
Context: The hyperglycemia is an important independent risk factor for the Surgical Site Infection (SSI) development among liver transplantation recipients. Objective: To evaluate the effects of an intensive postoperative protocol of blood glucose management on the surgical site infection incidence among liver transplantation recipients. Material and methods: It is an open-label clinical trial that will be randomized into 2 groups of blood glucose (BG) control: patients will undergo BG control regular in the facility chosen to research development (BG targeted 130-180 mg/dL) and the second one will undergo intensive BG control (BG targeted 80 - 130 mg/dL) until patients are eating at least 50% of a full liquid diet or receiving bolus tube feedings. A computer program will be employed to generate the randomized schedule that will be put into sequentially numbered opaque sealed envelopes by an external expert to research. A finger prick device will be used to measure the blood glucose. A blinded adjudication committee to analyse the primary endpoint SSI will adopt the SSI criteria given by the Centers for Disease Control and Prevention. The research proposal will be registered on ClinicalTrials.gov database. Central tendency and dispersion measures, Pearson's χ2 test, Fisher's Exact Test, Mann-Whitney, Wilcoxon-Mann-Whitney and survival analysis by Kaplan-Meier estimated and Log-rank test will be used for data analyses. Expected outcomes: The results of the study should contribute to establishing better clinical practices on glycemic control in the liver transplantation recipient's postoperative period aiming to reduce SSI incidence and its associated morbidity and mortality.
Read the detailed description
The Surgical Site Infections (SSI's) are the most frequent healthcare-associated infections and are an important infectious complication in the postoperative period among liver transplantation (LT) recipients. SSI incidence among LT recipients, whose allografts were from deceased donors, varied from 9.6% to 35.5% according to a recent literature review. In general surgical procedures, SSI increases the length of stay, morbidity and healthcare costs. Besides that, among LT recipients SSI can raise the risks of the allografts dysfunctions, acute rejections and as a consequence a reduction in the recipient's survival.
There are several risk factors for SSI among LT recipients. There is a relationship among supply sterilization quality, the characteristics of surgical procedure, the operation room environment as well as the allograft's and recipient's conditions and SSI occurrence. In regard to LT recipients, results from previous research highlighted hyperglycemia as an important independent predictor of SSI. Furthermore, regarding this population, it is known from observational studies that LT recipients affected by hyperglycemia are exposed, approximately, to three times the risk of SSI comparatively to LT recipients not exposed.
The concern about maintaining normoglycaemia in acute care facilities is not recent; several studies have been done including on clinical and surgical patients from some medical specialities showing the morbidity and mortality reduction throughout the adoption of strict glycaemic control protocols.
However, among critical surgical patients the LT recipients are highlighted; since they are exposed to impairment in blood glucose metabolism in the perioperative period as a consequence of an intraoperative acute stress state, blood loss and transfusions, the reperfusion phase, use of glucocorticoids and catecholamines.
Results from previous studies pointed the hyperglycaemia among LT recipient as a frequent complication, 94% of them presented it at least once in the transplantation's postoperative period.
The high blood glucose levels can produce electrolyte and acid-base disturbances besides altered plasmatic distribution of sodium. There are impairments to the white blood cells activities, such as reduction in the adherence, chemotaxis, phagocytosis and superoxide formation. Lymphocytes apoptosis combined with T-cell activities suppression besides attenuation of immunoglobulin's work as a consequence of glycosylation.
In spite of evidence from laboratory studies that indicate remarkable impairments caused by hyperglycemia in immune model animals immunologic system, uncertainties remain to evaluate the glycaemic control as a strategy for SSI prevention. Analysing the guidelines to prevent SSI published by World Health Organization, Centers for Disease Control and Prevention (United States of America), National Institute for Health and Care Excellence (United Kingdom), Society for Healthcare Epidemiology of America (United States of America) and Brazilian Health Regulatory Agency conditional recommendation regard the adoption of strategies to strict glycaemic control in the postoperative phase, besides there is no consensus about how glycaemic level could work as a protective factor for SSI among patients who underwent general surgeries.
Moreover, there have been few investigations evaluating the hyperglycaemia effects or blood glucose control in the postoperative phase of LT recipients. Besides the few studies concerned on the topic among LT recipients, the majority of them were observational studies, designed as retrospective cohorts, which could compromise the body's evidence quality. Also, in the previous studies enrolled patients underwent liver-kidney transplantation, which can cause a negative impact on the effects of glycemic control analyses and there is research where recipients presented lower means of Model for End-Stage Liver Disease (MELD) from 19.0 to 28.2 that are lower MELD means than the observed in Brazilian transplantation centres. Finally, we observed the absence of clear criteria for SSI diagnosis in some studies.
It is known that the preoperative screening in living donor LT of donors and recipients as baseline characteristics are different of LT whose allografts came from deceased donors; for instance, liver-kidney recipients who undergo to distinct immunosuppression schemes. Furthermore, lower MELD scores represent LT recipients that could be exposed to diverse risk factors for SSI when compared to LT recipients who the MELD score is higher.
Thus, it sounds appropriate that research aiming to evaluate the effect of strict blood glucose control on SSI incidence among LT recipients should be made. In addition, nurse-initiated blood glucose control protocols, among critically ill patients, are frequently developed. And, a recent literature review pointed to the lack of prospective studies that addressed the evaluation of the outcomes of strict glycaemic control among LT recipients on SSI incidence.
The study hypothesis is: the postoperative strict glycaemic control reduces the SSI incidence among LT recipients.
- Conditions
- Liver Transplantation, Surgical Wound Infection
- Being tested
- Strict Glycemic Control Group, Standard Glycemic Control Group
- Keywords
- Liver Transplantation, Surgical Wound Infection, Hiperglycemia
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strict Glycemic Control GroupProcedure or surgery
The strict protocol adopted to conduct the study was proposed by Keegan e Cols.(2010) to be used among adult LT recipients that consist of a continuous intravenous insulin infusion. The targeted blood glucose range is 80-130 mg/dL. The procedure must be stopped when the patient can ingest at least 50% of liquid diet or receive bolus tube feedings.
Standard Glycemic Control GroupProcedure or surgery
The targeted blood glucose range is 130-180 mg/dL
- Blood glucose reading: ≤ 180 mg/dL - subcutaneous insulin dose: 0
- Blood glucose reading: ≥181 mg/dL and ≤250 mg/dL - subcutaneous insulin dose: 5 IU
- Blood glucose reading: ≥251 mg/dL and ≤300 mg/dL - subcutaneous insulin dose: 10 IU
- Blood glucose reading: ≥301 - subcutaneous insulin dose: 15 IU
| Study group | Role | What they receive |
|---|---|---|
| Strict Glycemic Control Group | Active comparator | Intravenous insulin as described by Keegan and Cols. 2010. Receives: Procedure: Strict Glycemic Control Group |
| Standard Glycemic Control Group | Active comparator | Subcutaneous insulin as instititional protocol. Receives: Procedure: Standard Glycemic Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site Infection
Surgical site infection following the Centers for Disease Control and Prevention defining criteria (2018)
Measured: SSI occurs within 30 days after the LT
Secondary outcomes (8)
Hyperglycemia
Hyperglycemia > 250 mg/dL
Measured: During first 48h ICU stay
Hypoglycemia
Hypoglycemia < 60 mg/dL
Measured: During first 48h ICU stay
Duration of mechanical ventilation
Duration of mechanical ventilation through postoperative ICU stay
Measured: Within 30 days after LT
ICU stay
ICU stay until 30 days after LT
Measured: Within 30 days after LT
Ward stay
Postoperative ward stay
Measured: Within 30 days after LT
Death
Death within 90 days after LT
Measured: 90 days after LT
Surgical Site Infection or death
Surgical site infection following the Centers for Disease Control and Prevention defining criteria (2018)
Measured: Surgical site infection within 20 days following liver transplantation or death within 90 days following liver transplantation
Hospital length of stay
Time between the hospital admission to liver transplantation and hospital discharge
Measured: Until 100 weeks after liver transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start11 Mar 2018
- Primary completion25 Oct 2019
- Study completion15 Jan 2020
Why it stopped: The data safety monitoring inboard recommended stopping the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Insulin initially as continuous infusion/subcutaneous for first 24-48 hours followed by subcutaneous administration once subjects eating until hospital discharge.
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ramon Oliveira
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ramon Oliveira, University of Sao Paulo
- Investigators
- Vanessa B Poveda, Ph.D, Study chairJudith Tanner, Ph.D, Study directorJorge M Padilla, M.Sc, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03474666
- Sponsor's protocol ID
- 80351717.7.0000.5392
- Other IDs
- U1111-1210-2322
- Status last verified
- Mar 2020
- First submitted
- 2 Mar 2018
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oliveira RA, Tanner J, Mancero JMP, de Brito Poveda V. Effects of Intensive Blood Glucose Control on Surgical Site Infection for Liver Transplant Recipients: A Randomized Controlled Trial. Transplant Proc. 2023 Jan-Feb;55(1):170-177. doi: 10.1016/j.transproceed.2022.10.062. Epub 2022 Dec 24.
PubMed 36567173
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Glycemic Control and the Surgical Site Infection Incidence Among Liver Transplantation Recipients: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03474666
- Acronym / sponsor ID
- 80351717.7.0000.5392
- Conditions
- Liver Transplantation, Surgical Wound Infection
- Keywords
- Liver Transplantation, Surgical Wound Infection, Hiperglycemia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The data safety monitoring inboard recommended stopping the study.
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Ramon OliveiraUniversity, hospital or other
- Study start
- 11 Mar 2018 (actual)
- Primary completion
- 25 Oct 2019 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 22 Mar 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.
Context: The hyperglycemia is an important independent risk factor for the Surgical Site Infection (SSI) development among liver transplantation recipients. Objective: To evaluate the effects of an intensive postoperative protocol of blood glucose management on the surgical site infection incidence among liver transplantation recipients. Material and methods: It is an open-label clinical trial that will be randomized into 2 groups of blood glucose (BG) control: patients will undergo BG control regular in the facility chosen to research development (BG targeted 130-180 mg/dL) and the second one will undergo intensive BG control (BG targeted 80 - 130 mg/dL) until patients are eating at least 50% of a full liquid diet or receiving bolus tube feedings. A computer program will be employed to generate the randomized schedule that will be put into sequentially numbered opaque sealed envelopes by an external expert to research. A finger prick device will be used to measure the blood glucose. A blinded adjudication committee to analyse the primary endpoint SSI will adopt the SSI criteria given by the Centers for Disease Control and Prevention. The research proposal will be registered on ClinicalTrials.gov database. Central tendency and dispersion measures, Pearson's χ2 test, Fisher's Exact Test, Mann-Whitney, Wilcoxon-Mann-Whitney and survival analysis by Kaplan-Meier estimated and Log-rank test will be used for data analyses. Expected outcomes: The results of the study should contribute to establishing better clinical practices on glycemic control in the liver transplantation recipient's postoperative period aiming to reduce SSI incidence and its associated morbidity and mortality.
Detailed description
The Surgical Site Infections (SSI's) are the most frequent healthcare-associated infections and are an important infectious complication in the postoperative period among liver transplantation (LT) recipients. SSI incidence among LT recipients, whose allografts were from deceased donors, varied from 9.6% to 35.5% according to a recent literature review. In general surgical procedures, SSI increases the length of stay, morbidity and healthcare costs. Besides that, among LT recipients SSI can raise the risks of the allografts dysfunctions, acute rejections and as a consequence a reduction in the recipient's survival.
There are several risk factors for SSI among LT recipients. There is a relationship among supply sterilization quality, the characteristics of surgical procedure, the operation room environment as well as the allograft's and recipient's conditions and SSI occurrence. In regard to LT recipients, results from previous research highlighted hyperglycemia as an important independent predictor of SSI. Furthermore, regarding this population, it is known from observational studies that LT recipients affected by hyperglycemia are exposed, approximately, to three times the risk of SSI comparatively to LT recipients not exposed.
The concern about maintaining normoglycaemia in acute care facilities is not recent; several studies have been done including on clinical and surgical patients from some medical specialities showing the morbidity and mortality reduction throughout the adoption of strict glycaemic control protocols.
However, among critical surgical patients the LT recipients are highlighted; since they are exposed to impairment in blood glucose metabolism in the perioperative period as a consequence of an intraoperative acute stress state, blood loss and transfusions, the reperfusion phase, use of glucocorticoids and catecholamines.
Results from previous studies pointed the hyperglycaemia among LT recipient as a frequent complication, 94% of them presented it at least once in the transplantation's postoperative period.
The high blood glucose levels can produce electrolyte and acid-base disturbances besides altered plasmatic distribution of sodium. There are impairments to the white blood cells activities, such as reduction in the adherence, chemotaxis, phagocytosis and superoxide formation. Lymphocytes apoptosis combined with T-cell activities suppression besides attenuation of immunoglobulin's work as a consequence of glycosylation.
In spite of evidence from laboratory studies that indicate remarkable impairments caused by hyperglycemia in immune model animals immunologic system, uncertainties remain to evaluate the glycaemic control as a strategy for SSI prevention. Analysing the guidelines to prevent SSI published by World Health Organization, Centers for Disease Control and Prevention (United States of America), National Institute for Health and Care Excellence (United Kingdom), Society for Healthcare Epidemiology of America (United States of America) and Brazilian Health Regulatory Agency conditional recommendation regard the adoption of strategies to strict glycaemic control in the postoperative phase, besides there is no consensus about how glycaemic level could work as a protective factor for SSI among patients who underwent general surgeries.
Moreover, there have been few investigations evaluating the hyperglycaemia effects or blood glucose control in the postoperative phase of LT recipients. Besides the few studies concerned on the topic among LT recipients, the majority of them were observational studies, designed as retrospective cohorts, which could compromise the body's evidence quality. Also, in the previous studies enrolled patients underwent liver-kidney transplantation, which can cause a negative impact on the effects of glycemic control analyses and there is research where recipients presented lower means of Model for End-Stage Liver Disease (MELD) from 19.0 to 28.2 that are lower MELD means than the observed in Brazilian transplantation centres. Finally, we observed the absence of clear criteria for SSI diagnosis in some studies.
It is known that the preoperative screening in living donor LT of donors and recipients as baseline characteristics are different of LT whose allografts came from deceased donors; for instance, liver-kidney recipients who undergo to distinct immunosuppression schemes. Furthermore, lower MELD scores represent LT recipients that could be exposed to diverse risk factors for SSI when compared to LT recipients who the MELD score is higher.
Thus, it sounds appropriate that research aiming to evaluate the effect of strict blood glucose control on SSI incidence among LT recipients should be made. In addition, nurse-initiated blood glucose control protocols, among critically ill patients, are frequently developed. And, a recent literature review pointed to the lack of prospective studies that addressed the evaluation of the outcomes of strict glycaemic control among LT recipients on SSI incidence.
The study hypothesis is: the postoperative strict glycaemic control reduces the SSI incidence among LT recipients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Insulin initially as continuous infusion/subcutaneous for first 24-48 hours followed by subcutaneous administration once subjects eating until hospital discharge.
| Arm | Type | Receives |
|---|---|---|
| Strict Glycemic Control Group | Active comparator | Procedure: Strict Glycemic Control GroupIntravenous insulin as described by Keegan and Cols. 2010. |
| Standard Glycemic Control Group | Active comparator | Procedure: Standard Glycemic Control GroupSubcutaneous insulin as instititional protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Recipients of LT whose allograft came from deceased donors
- Able to give informed consent personally or via a family member who has appropriate authorization to do so if patient unconscious.
- Blood glucose level over 130 mg/dL in the first 24 hours postoperatively
Key exclusion criteria (2 listed)
- The patients that underwent any kind of surgery with or without prosthesis implant in the 30 days before the LT
- Recipients submitted to multiple organ transplantation
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 |
|---|---|---|
| Strict Glycemic Control GroupThe strict protocol adopted to conduct the study was proposed by Keegan e Cols.(2010) to be used among adult LT recipients that consist of a continuous intravenous insulin infusion. The targeted blood glucose range is 80-130 mg/dL. The procedure must be stopped when the patient can ingest at least 50% of liquid diet or receive bolus tube feedings. | Procedure or surgery | Strict Glycemic Control Group |
| Standard Glycemic Control GroupThe targeted blood glucose range is 130-180 mg/dL * Blood glucose reading: ≤ 180 mg/dL - subcutaneous insulin dose: 0 * Blood glucose reading: ≥181 mg/dL and ≤250 mg/dL - subcutaneous insulin dose: 5 IU * Blood glucose reading: ≥251 mg/dL and ≤300 mg/dL - subcutaneous insulin dose: 10 IU * Blood glucose reading: ≥301 - subcutaneous insulin dose: 15 IU | Procedure or surgery | Standard Glycemic Control Group |
Primary outcome
Surgical Site Infection
Time frame: SSI occurs within 30 days after the LT
Surgical site infection following the Centers for Disease Control and Prevention defining criteria (2018)
8 secondary outcomes
Hyperglycemia
Time frame: During first 48h ICU stay
Hypoglycemia
Time frame: During first 48h ICU stay
Duration of mechanical ventilation
Time frame: Within 30 days after LT
ICU stay
Time frame: Within 30 days after LT
Ward stay
Time frame: Within 30 days after LT
Death
Time frame: 90 days after LT
Surgical Site Infection or death
Time frame: Surgical site infection within 20 days following liver transplantation or death within 90 days following liver transplantation
Hospital length of stay
Time frame: Until 100 weeks after liver transplantation
Results and safety
The study was stopped early (reason given: The data safety monitoring inboard recommended stopping the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Derived from this study: PubMed 36567173Oliveira RA, Tanner J, Mancero JMP, de Brito Poveda V. Effects of Intensive Blood Glucose Control on Surgical Site Infection for Liver Transplant Recipients: A Randomized Controlled Trial. Transplant Proc. 2023 Jan-Feb;55(1):170-177. doi: 10.1016/j.transproceed.2022.10.062. Epub 2022 Dec 24.
- Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017Link provided by the sponsor.
- Effect of antibiotic prophylaxis on the risk of surgical site infection in orthotopic liver transplantLink provided by the sponsor.
- The effect of surgical site infections on outcomes and resource utilization after liver transplantationLink provided by the sponsor.
- Risk factors for development of surgical site infections among liver transplantation recipients: An integrative literature reviewLink provided by the sponsor.
- Bacteremia and septic shock after solid-organ transplantation.Link provided by the sponsor.
- The direct and indirect effects of infection in liver transplantation: pathogenesis, impact, and clinical management.Link provided by the sponsor.
- 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.
Vanessa B Poveda, Ph.D study chair
Judith Tanner, Ph.D study director
Jorge M Padilla, M.Sc study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Liver Transplantation and Surgical Wound Infection, run by Ramon Oliveira at 1 site in Brazil.
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 2 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: stopped early, as of the sponsor's last update on 26 Mar 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 Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The data safety monitoring inboard recommended stopping the study.). Results are not available in the source record.
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?
Surgical Site Infection (time frame: SSI occurs within 30 days after the LT). 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 NCT03474666, which also lists 1 linked publication.
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 26 Mar 2020; AzTrials last refreshed its copy on 8 Nov 2026.