Intradialytic HypotensionIDH-MHDNCT07545629
Epidemiology And Risk Factors Of Intradialytic Hypotension In Maintenance Hemodialysis Patients
An observational study of Intradialytic Hypotension and End-stage Renal Disease (ESRD), run by First Affiliated Hospital of Wannan Medical College at 1 site in China.
Trial summary
This prospective, multicenter observational study aims to describe how often intradialytic hypotension (IDH) occurs and to identify its risk factors in adult patients receiving maintenance hemodialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intradialytic Hypotension, End-stage Renal Disease (ESRD), Chronic Kidney Failure
- How many people
- 395 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2025to 29 Dec 2025
- How long will I take part?
- 1 Day
- 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: Adults with end-stage renal disease receiving routine maintenance hemodialysis at participating centers. Consecutive eligible patients will be observed during one scheduled dialysis session to estimate single-session IDH incidence and explore associated factors.
Who may be able to join
- Adults (≥18 years) with end-stage renal disease on maintenance hemodialysis
- Receiving thrice-weekly (or routine) in-center hemodialysis for ≥3 months before enrollment
- Scheduled for a standard hemodialysis session of approximately 3-5 hours on the study day
- Able to provide informed consent (or via legally authorized representative, if applicable)
Who cannot join
- Acute medical instability precluding observation of a routine dialysis session (e.g., active sepsis requiring vasopressors, uncontrolled arrhythmias)
- Recent acute coronary syndrome or stroke within 3 months
- Pre-dialysis systolic blood pressure <90 mmHg on the study day before starting dialysis
- Ongoing active major bleeding or anticipated urgent transfusion during the session
- Pregnancy
- Participation in an interventional trial expected to alter intradialytic blood pressure during the observed session
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)
Wuhu, Anhui, 241001
About this study
Official title: Epidemiologic Characteristics And Risk Factors Of Intradialytic Hypotension In Maintenance Hemodialysis Patients: A Prospective Multicenter Cross-sectional Study
This prospective, multicenter observational study aims to describe how often intradialytic hypotension (IDH) occurs and to identify its risk factors in adult patients receiving maintenance hemodialysis. Intradialytic hypotension is a common complication during dialysis that can lead to symptoms, organ hypoperfusion, and interruption of treatment.
Participants will be adults on regular maintenance hemodialysis who meet predefined inclusion and exclusion criteria. Routine clinical information will be collected, including demographics, primary kidney disease, comorbidities, medications, dialysis vintage, dialysis prescription (ultrafiltration volume and rate, dialysate composition, treatment time), and standard laboratory tests. During a defined observation period, blood pressure and related symptoms will be recorded across dialysis sessions to document the frequency, severity, and patterns of IDH.
The main goals are to estimate the incidence and prevalence of intradialytic hypotension in maintenance hemodialysis patients and to explore potential risk factors, such as patient characteristics, cardiovascular status, volume status, and dialysis-related parameters. The findings may help clinicians better recognize patients at high risk of IDH and optimize dialysis prescriptions and monitoring strategies to reduce the occurrence of IDH and its adverse consequences.
Read the detailed description
This is a prospective, multicenter, observational study designed to characterize the epidemiology and risk factors of intradialytic hypotension (IDH) in adult patients undergoing maintenance hemodialysis. No study-specific interventions will be assigned; all dialysis treatments and medical therapies will be conducted according to routine clinical practice at each participating center.
Eligible participants are adults receiving thrice-weekly or regular maintenance hemodialysis for end-stage kidney disease. After obtaining informed consent (as required by local regulations), baseline data will be collected from the medical record and patient interview. Baseline variables will include:
Demographics (age, sex, body mass index, smoking status) Primary kidney disease and dialysis vintage Comorbidities (e.g., diabetes mellitus, hypertension, cardiovascular disease, heart failure, arrhythmia) Usual medications, with a focus on antihypertensive agents, diuretics, and cardiovascular drugs Pre-dialysis clinical parameters (weight, dry weight, interdialytic weight gain, pre-dialysis blood pressure) Routine laboratory values (e.g., hemoglobin, albumin, electrolytes, calcium-phosphate metabolism indices, markers of inflammation and nutrition, as available) Dialysis prescription and treatment-related parameters will be documented, including dialyzer type, blood flow rate, dialysate flow, dialysate composition (sodium, calcium, bicarbonate), treatment duration, and planned and achieved ultrafiltration volume and ultrafiltration rate.
During the observation period (covering a predefined number of consecutive dialysis sessions per patient), blood pressure will be monitored according to local standard practice (for example, before dialysis, at regular intervals during dialysis, and at the end of treatment). Episodes of intradialytic hypotension will be identified using a pre-specified definition (e.g., absolute blood pressure thresholds and/or drop from baseline, with or without associated symptoms), which will be applied consistently across all centers. When feasible, associated symptoms (such as dizziness, cramps, chest discomfort, nausea) and interventions (e.g., reduction or cessation of ultrafiltration, saline infusion, change in dialysate temperature, adjustment of position, or early termination of dialysis) will be recorded.
The primary analyses will describe:
The incidence and prevalence of intradialytic hypotension in this maintenance hemodialysis population The distribution of IDH episodes by dialysis session phase (early, middle, late), severity, and need for intervention
Secondary analyses will evaluate potential risk factors for IDH. These may include:
Baseline patient characteristics (age, sex, body mass index, primary disease, comorbidities) Indicators of cardiovascular function and volume status (pre-dialysis blood pressure, interdialytic weight gain, dry weight assessment) Laboratory parameters reflecting anemia, nutritional status, mineral metabolism, and inflammation Dialysis-related factors (treatment time, ultrafiltration volume and rate, dialysate sodium and temperature, antihypertensive medications taken before dialysis) Multivariable regression models or other appropriate statistical methods will be used to examine associations between candidate risk factors and the occurrence of IDH, while adjusting for potential confounders. Subgroup or sensitivity analyses may be performed according to age groups, presence of diabetes or cardiovascular disease, or different ultrafiltration rate categories, depending on sample size and data completeness.
This study is not intended to test a specific therapeutic intervention but to provide a comprehensive, real-world description of intradialytic hypotension and its determinants in maintenance hemodialysis patients across multiple centers. The results may support the development of risk stratification tools and guide future interventional studies aimed at preventing or mitigating intradialytic hypotension.
- Conditions
- Intradialytic Hypotension, End-stage Renal Disease (ESRD), Chronic Kidney Failure, Chronic Kidney Disease, Stage IV (Severe), Hemodialysis
- Keywords
- Maintenance hemodialysis, Intradialytic hypotension (IDH), Ultrafiltration rate (UFR), Interdialytic weight gain (IDWG), Blood pressure variability, Dialysate sodium, Volume status, Cardiovascular comorbidity, Prospective observational, Multicenter
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Maintenance Hemodialysis Cohort | Adults with end-stage renal disease receiving routine maintenance hemodialysis at participating centers. Prospective observation over approximately 3 months; no study-assigned interventions. Standard dialysis care per local practice. Data collected include demographics, comorbidities, medications, dialysis vintage, prescription (UF volume/rate, dialysate sodium/calcium/bicarbonate, temperature, treatment time), blood pressure before/during/after dialysis, IDH symptoms, and clinical responses (e.g., UF reduction, saline, cooling). Routine labs as available. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence Of Intradialytic Hypotension During A Single Maintenance Hemodialysis Session
Proportion of enrolled maintenance hemodialysis patients who experience intradialytic hypotension (IDH) during one observed hemodialysis session. IDH is defined as a decrease in systolic blood pressure (SBP) by 20-40 mmHg from pre-dialysis or during dialysis, with or without related symptoms, according to pre-specified criteria.
Measured: From the start of the observed hemodialysis session to the end of the same session (approximately 3.5-4 hours).
Secondary outcomes (7)
Incidence Of Asymptomatic IDH
Proportion of enrolled patients who develop asymptomatic IDH during the observed hemodialysis session. Asymptomatic IDH is defined as a decrease in SBP of 20-40 mmHg during dialysis without accompanying IDH-related symptoms
Measured: From the start of the observed hemodialysis session to the end of the same session (approximately 3.5-4 hours).
Distribution Of Time To Onset Of Intradialytic Hypotension
Proportion of IDH events that occur within each hour of the dialysis treatment (first, second, third, and last treatment hour), based on blood pressure measurements before dialysis, every 60 minutes during dialysis, and at the end of dialysis.
Measured: From the start of the observed hemodialysis session to the end of the same session (approximately 3.5-4 hours).
Association Between Pre-Dialysis Mean Arterial Pressure And IDH
Association between pre-dialysis mean arterial pressure (MAP, continuous and categorized by pre-specified cut-offs) and the occurrence of IDH during the observed session, quantified using multivariable logistic regression and reported as adjusted odds ratios (ORs) with 95% confidence intervals.
Measured: From pre-dialysis blood pressure assessment immediately before the session to the end of the same hemodialysis session (approximately 3.5-4 hours).
Association Between Interdialytic Weight Gain And IDH
Association between interdialytic weight gain (IDWG, kg) before the observed dialysis session and the occurrence of IDH during that session, assessed by multivariable logistic regression and expressed as adjusted odds ratios (ORs) with 95% confidence intervals.
Measured: From the pre-dialysis weight assessment immediately before the session to the end of the same hemodialysis session (approximately 3.5-4 hours).
Association Between Pre-Dialysis Serum Potassium And IDH
Association between pre-dialysis serum potassium concentration (continuous and dichotomized using a pre-defined cut-off) and the occurrence of IDH during the observed dialysis session, using multivariable logistic regression; reported as adjusted odds ratios (ORs) with 95% confidence intervals.
Measured: Based on the most recent pre-dialysis serum potassium value within 3 months prior to the observed session and IDH occurrence during that single hemodialysis session (approximately 3.5-4 hours).
Association Between Serum Albumin And IDH
Association between serum albumin level (continuous and categorized by pre-specified cut-offs) and the occurrence of IDH during the observed hemodialysis session, assessed using multivariable logistic regression models and expressed as adjusted odds ratios (ORs) with 95% confidence intervals.
Measured: Based on the most recent serum albumin measurement within 3 months prior to the observed session and IDH occurrence during that single hemodialysis session (approximately 3.5-4 hours).
Predictive Performance Of Traditional Clinical Indicators For IDH
Discriminative ability of traditional clinical and laboratory indicators (including pre-dialysis SBP, MAP, DBP, IDWG, ultrafiltration rate, pre-dialysis serum potassium, serum albumin, HDL, and pre-dialysis weight) for predicting IDH during the observed session, evaluated using receiver operating characteristic (ROC) curves and reported as area under the curve (AUC) with 95% confidence intervals.
Measured: Based on baseline measurements (collected within 3 months before the observed session or immediately pre-dialysis) and IDH occurrence during that single hemodialysis session (approximately 3.5-4 hours).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start15 Feb 2025
- Primary completion28 Feb 2025
- Study completion29 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intradialytic HypotensionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 395 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Wannan Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Wuhu City Second People's Hospital, Wuhu County Traditional Chinese Medicine Hospital
- Responsible party
- Principal investigator, Qiancheng Xu, First Affiliated Hospital of Wannan Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07545629
- Sponsor's protocol ID
- 2025-61-02
- Acronym
- IDH-MHD
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiologic Characteristics And Risk Factors Of Intradialytic Hypotension In Maintenance Hemodialysis Patients: A Prospective Multicenter Cross-sectional Study
- ClinicalTrials.gov ID
- NCT07545629
- Acronym / sponsor ID
- IDH-MHD / 2025-61-02
- Conditions
- Intradialytic Hypotension, End-stage Renal Disease (ESRD), Chronic Kidney Failure, Chronic Kidney Disease, Stage IV (Severe), Hemodialysis
- Keywords
- Maintenance hemodialysis, Intradialytic hypotension (IDH), Ultrafiltration rate (UFR), Interdialytic weight gain (IDWG), Blood pressure variability, Dialysate sodium, Volume status, Cardiovascular comorbidity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 395 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Wannan Medical CollegeUniversity, hospital or other
- Collaborators
- Wuhu City Second People's Hospital, Wuhu County Traditional Chinese Medicine Hospital
- Study start
- 15 Feb 2025 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 29 Dec 2025 (actual)
- First posted
- 22 Apr 2026 (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.
This prospective, multicenter observational study aims to describe how often intradialytic hypotension (IDH) occurs and to identify its risk factors in adult patients receiving maintenance hemodialysis. Intradialytic hypotension is a common complication during dialysis that can lead to symptoms, organ hypoperfusion, and interruption of treatment.
Participants will be adults on regular maintenance hemodialysis who meet predefined inclusion and exclusion criteria. Routine clinical information will be collected, including demographics, primary kidney disease, comorbidities, medications, dialysis vintage, dialysis prescription (ultrafiltration volume and rate, dialysate composition, treatment time), and standard laboratory tests. During a defined observation period, blood pressure and related symptoms will be recorded across dialysis sessions to document the frequency, severity, and patterns of IDH.
The main goals are to estimate the incidence and prevalence of intradialytic hypotension in maintenance hemodialysis patients and to explore potential risk factors, such as patient characteristics, cardiovascular status, volume status, and dialysis-related parameters. The findings may help clinicians better recognize patients at high risk of IDH and optimize dialysis prescriptions and monitoring strategies to reduce the occurrence of IDH and its adverse consequences.
Detailed description
This is a prospective, multicenter, observational study designed to characterize the epidemiology and risk factors of intradialytic hypotension (IDH) in adult patients undergoing maintenance hemodialysis. No study-specific interventions will be assigned; all dialysis treatments and medical therapies will be conducted according to routine clinical practice at each participating center.
Eligible participants are adults receiving thrice-weekly or regular maintenance hemodialysis for end-stage kidney disease. After obtaining informed consent (as required by local regulations), baseline data will be collected from the medical record and patient interview. Baseline variables will include:
Demographics (age, sex, body mass index, smoking status) Primary kidney disease and dialysis vintage Comorbidities (e.g., diabetes mellitus, hypertension, cardiovascular disease, heart failure, arrhythmia) Usual medications, with a focus on antihypertensive agents, diuretics, and cardiovascular drugs Pre-dialysis clinical parameters (weight, dry weight, interdialytic weight gain, pre-dialysis blood pressure) Routine laboratory values (e.g., hemoglobin, albumin, electrolytes, calcium-phosphate metabolism indices, markers of inflammation and nutrition, as available) Dialysis prescription and treatment-related parameters will be documented, including dialyzer type, blood flow rate, dialysate flow, dialysate composition (sodium, calcium, bicarbonate), treatment duration, and planned and achieved ultrafiltration volume and ultrafiltration rate.
During the observation period (covering a predefined number of consecutive dialysis sessions per patient), blood pressure will be monitored according to local standard practice (for example, before dialysis, at regular intervals during dialysis, and at the end of treatment). Episodes of intradialytic hypotension will be identified using a pre-specified definition (e.g., absolute blood pressure thresholds and/or drop from baseline, with or without associated symptoms), which will be applied consistently across all centers. When feasible, associated symptoms (such as dizziness, cramps, chest discomfort, nausea) and interventions (e.g., reduction or cessation of ultrafiltration, saline infusion, change in dialysate temperature, adjustment of position, or early termination of dialysis) will be recorded.
The primary analyses will describe:
The incidence and prevalence of intradialytic hypotension in this maintenance hemodialysis population The distribution of IDH episodes by dialysis session phase (early, middle, late), severity, and need for intervention
Secondary analyses will evaluate potential risk factors for IDH. These may include:
Baseline patient characteristics (age, sex, body mass index, primary disease, comorbidities) Indicators of cardiovascular function and volume status (pre-dialysis blood pressure, interdialytic weight gain, dry weight assessment) Laboratory parameters reflecting anemia, nutritional status, mineral metabolism, and inflammation Dialysis-related factors (treatment time, ultrafiltration volume and rate, dialysate sodium and temperature, antihypertensive medications taken before dialysis) Multivariable regression models or other appropriate statistical methods will be used to examine associations between candidate risk factors and the occurrence of IDH, while adjusting for potential confounders. Subgroup or sensitivity analyses may be performed according to age groups, presence of diabetes or cardiovascular disease, or different ultrafiltration rate categories, depending on sample size and data completeness.
This study is not intended to test a specific therapeutic intervention but to provide a comprehensive, real-world description of intradialytic hypotension and its determinants in maintenance hemodialysis patients across multiple centers. The results may support the development of risk stratification tools and guide future interventional studies aimed at preventing or mitigating intradialytic hypotension.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Maintenance Hemodialysis Cohort | – | –Adults with end-stage renal disease receiving routine maintenance hemodialysis at participating centers. Prospective observation over approximately 3 months; no study-assigned interventions. Standard dialysis care per local practice. Data collected include demographics, comorbidities, medications, dialysis vintage, prescription (UF volume/rate, dialysate sodium/calcium/bicarbonate, temperature, treatment time), blood pressure before/during/after dialysis, IDH symptoms, and clinical responses (e.g., UF reduction, saline, cooling). Routine labs as available. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with end-stage renal disease receiving routine maintenance hemodialysis at participating centers. Consecutive eligible patients will be observed during one scheduled dialysis session to estimate single-session IDH incidence and explore associated factors.
Key inclusion criteria (4 listed)
- Adults (≥18 years) with end-stage renal disease on maintenance hemodialysis
- Receiving thrice-weekly (or routine) in-center hemodialysis for ≥3 months before enrollment
- Scheduled for a standard hemodialysis session of approximately 3-5 hours on the study day
- Able to provide informed consent (or via legally authorized representative, if applicable)
Key exclusion criteria (6 listed)
- Acute medical instability precluding observation of a routine dialysis session (e.g., active sepsis requiring vasopressors, uncontrolled arrhythmias)
- Recent acute coronary syndrome or stroke within 3 months
- Pre-dialysis systolic blood pressure <90 mmHg on the study day before starting dialysis
- Ongoing active major bleeding or anticipated urgent transfusion during the session
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence Of Intradialytic Hypotension During A Single Maintenance Hemodialysis Session
Time frame: From the start of the observed hemodialysis session to the end of the same session (approximately 3.5-4 hours).
Proportion of enrolled maintenance hemodialysis patients who experience intradialytic hypotension (IDH) during one observed hemodialysis session. IDH is defined as a decrease in systolic blood pressure (SBP) by 20-40 mmHg from pre-dialysis or during dialysis, with or without related symptoms, according to pre-specified criteria.
7 secondary outcomes
Incidence Of Asymptomatic IDH
Time frame: From the start of the observed hemodialysis session to the end of the same session (approximately 3.5-4 hours).
Distribution Of Time To Onset Of Intradialytic Hypotension
Time frame: From the start of the observed hemodialysis session to the end of the same session (approximately 3.5-4 hours).
Association Between Pre-Dialysis Mean Arterial Pressure And IDH
Time frame: From pre-dialysis blood pressure assessment immediately before the session to the end of the same hemodialysis session (approximately 3.5-4 hours).
Association Between Interdialytic Weight Gain And IDH
Time frame: From the pre-dialysis weight assessment immediately before the session to the end of the same hemodialysis session (approximately 3.5-4 hours).
Association Between Pre-Dialysis Serum Potassium And IDH
Time frame: Based on the most recent pre-dialysis serum potassium value within 3 months prior to the observed session and IDH occurrence during that single hemodialysis session (approximately 3.5-4 hours).
Association Between Serum Albumin And IDH
Time frame: Based on the most recent serum albumin measurement within 3 months prior to the observed session and IDH occurrence during that single hemodialysis session (approximately 3.5-4 hours).
Predictive Performance Of Traditional Clinical Indicators For IDH
Time frame: Based on baseline measurements (collected within 3 months before the observed session or immediately pre-dialysis) and IDH occurrence during that single hemodialysis session (approximately 3.5-4 hours).
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 22 Apr 2026.
- 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.
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?
An observational study of Intradialytic Hypotension and End-stage Renal Disease (ESRD), run by First Affiliated Hospital of Wannan Medical College 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 6 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 22 Apr 2026. 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?
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?
Incidence Of Intradialytic Hypotension During A Single Maintenance Hemodialysis Session (time frame: From the start of the observed hemodialysis session to the end of the same session (approximately 3.5-4 hours).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2026.