Hypertensive EmergencyNCT06201572
The Value of TOI in Evaluating Renal Function Damage in Hypertensive Emergency Patients
An observational study of Hypertensive Emergency, run by The Affiliated Hospital of Hangzhou Normal University.
Trial summary
TOI was used to measure heart rate, respiration, blood pressure, heart rate variability and psychological stress. At the same time, the patient's urine protein, creatinine, urea nitrogen and other indicators were detected. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hypertensive Emergency
- What is being tested?
- The relationship between TOI composite index and renal function in hypertensive emergency patients was compared
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to 31 Dec 2024
- 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 to 90 years
- All sexes
- Adult, Older adult
Study population: Patients hospitalized for acute hypertension from January 2022 to December 2024 with onset time <48 hours and blood pressure measured by standard sphygmomanometer: Systolic blood pressure (SBP)>180mmHg and/or diastolic blood pressure (DBP)>120mmHg, age >18 years old, gender, stable vital signs, good compliance, complete and reliable medical records.
Who may be able to join
- Systolic blood pressure (SBP)>180mmHg
- Diastolic blood pressure (DBP)>120mmHg
Who cannot join
- Severe head and facial skin injury
- Cerebral hemorrhage or severe shock after admission
- Patients who insist on refusing to participate in this clinical tria
- Patients who could not participate in the study for other reasons.
About this study
Official title: The Value of Smartphone-based Optical Blood Spectrum Imaging (TOI) in Evaluating Renal Function Damage in Hypertensive Emergency Patients
TOI was used to measure heart rate, respiration, blood pressure, heart rate variability and psychological stress. At the same time, the patient's urine protein, creatinine, urea nitrogen and other indicators were detected. According to different renal function, they were divided into observation group and control group, and 100 general inpatients with renal insufficiency were selected as positive control group. The relationship between TOI composite index and renal function in hypertensive emergency patients was compared.
Read the detailed description
TOI technique was used to measure the heart rate, respiration, blood pressure, heart rate variability, psychological pressure, etc. At the same time, the urine protein, creatinine, urea nitrogen and other results of these patients were measured. According to the different renal function, they were divided into observation group and control group, and 100 ordinary hospitalized patients with renal insufficiency were selected as positive control group. The relationship between TOI composite index and renal function in hypertensive emergency patients was compared. The data management platform provides intelligent management of patients' out-of-hospital follow-up, and the dynamic physiological indicators and psychological assessment data of patients are mastered through the hospital port, so as to provide telemedicine guidance for patients, so as to improve the prognosis of hypertensive emergency patients.
- Conditions
- Hypertensive Emergency
- Being tested
- The relationship between TOI composite index and renal function in hypertensive emergency patients was compared
- Medical subject headings
- Hypertensive Crisis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The relationship between TOI composite index and renal function in hypertensive emergency patients was comparedOther
The relationship between TOI composite index and renal function in hypertensive emergency patients was compared. The data management platform provides intelligent management of patients' out-of-hospital follow-up, and the dynamic physiological indicators and psychological assessment data of patients are mastered through the hospital port, so as to provide telemedicine guidance for patients, so as to improve the prognosis of hypertensive emergency patients.
| Study group | Role | What they receive |
|---|---|---|
| Observation group | Not described Receives: Other: The relationship between TOI composite index and renal function in hypertensive emergency patients was compared | |
| Control group | Not described | |
| Positive control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure
Both systolic and diastolic Blood Pressure levels of enrolled patients
Measured: 2023-12-01 to 2024-12-31
creatinine
creatinine levels of enrolled patients
Measured: 2023-12-01 to 2024-12-31
urea nitrogen
urea nitrogen levels of enrolled patients
Measured: 2023-12-01 to 2024-12-31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start1 Feb 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertensive EmergencyStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Hangzhou Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06201572
- Sponsor's protocol ID
- AH-2023-001
- Status last verified
- Nov 2023
- First submitted
- 2 Jan 2024
- Last updated
- 22 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Smartphone-based Optical Blood Spectrum Imaging (TOI) in Evaluating Renal Function Damage in Hypertensive Emergency Patients
- ClinicalTrials.gov ID
- NCT06201572
- Acronym / sponsor ID
- AH-2023-001
- Conditions
- Hypertensive Emergency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Hangzhou Normal UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 11 Jan 2024 (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.
TOI was used to measure heart rate, respiration, blood pressure, heart rate variability and psychological stress. At the same time, the patient's urine protein, creatinine, urea nitrogen and other indicators were detected. According to different renal function, they were divided into observation group and control group, and 100 general inpatients with renal insufficiency were selected as positive control group. The relationship between TOI composite index and renal function in hypertensive emergency patients was compared.
Detailed description
TOI technique was used to measure the heart rate, respiration, blood pressure, heart rate variability, psychological pressure, etc. At the same time, the urine protein, creatinine, urea nitrogen and other results of these patients were measured. According to the different renal function, they were divided into observation group and control group, and 100 ordinary hospitalized patients with renal insufficiency were selected as positive control group. The relationship between TOI composite index and renal function in hypertensive emergency patients was compared. The data management platform provides intelligent management of patients' out-of-hospital follow-up, and the dynamic physiological indicators and psychological assessment data of patients are mastered through the hospital port, so as to provide telemedicine guidance for patients, so as to improve the prognosis of hypertensive emergency patients.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Observation group | – | Other: The relationship between TOI composite index and renal function in hypertensive emergency patients was compared |
| Control group | – | – |
| Positive control group | – | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized for acute hypertension from January 2022 to December 2024 with onset time <48 hours and blood pressure measured by standard sphygmomanometer: Systolic blood pressure (SBP)>180mmHg and/or diastolic blood pressure (DBP)>120mmHg, age >18 years old, gender, stable vital signs, good compliance, complete and reliable medical records.
Key inclusion criteria (2 listed)
- Systolic blood pressure (SBP)>180mmHg
- Diastolic blood pressure (DBP)>120mmHg
Key exclusion criteria (4 listed)
- Severe head and facial skin injury
- Cerebral hemorrhage or severe shock after admission
- Patients who insist on refusing to participate in this clinical tria
- Patients who could not participate in the study for other reasons.
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 relationship between TOI composite index and renal function in hypertensive emergency patients was comparedThe relationship between TOI composite index and renal function in hypertensive emergency patients was compared. The data management platform provides intelligent management of patients' out-of-hospital follow-up, and the dynamic physiological indicators and psychological assessment data of patients are mastered through the hospital port, so as to provide telemedicine guidance for patients, so as to improve the prognosis of hypertensive emergency patients. | Other | Observation group |
Primary outcome
blood pressure
Time frame: 2023-12-01 to 2024-12-31
Both systolic and diastolic Blood Pressure levels of enrolled patients
creatinine
Time frame: 2023-12-01 to 2024-12-31
creatinine levels of enrolled patients
urea nitrogen
Time frame: 2023-12-01 to 2024-12-31
urea nitrogen levels of enrolled patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertensive Emergency, run by The Affiliated Hospital of Hangzhou Normal University.
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 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
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 pressure (time frame: 2023-12-01 to 2024-12-31). The study lists 3 primary outcomes in all. 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 Jan 2024.