- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06201572
The Value of TOI in Evaluating Renal Function Damage in Hypertensive Emergency Patients
January 19, 2024 updated by: The Affiliated Hospital of Hangzhou Normal University
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.
Study Overview
Status
Not yet recruiting
Conditions
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 Type
Observational
Enrollment (Estimated)
300
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Probability Sample
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.
Description
Inclusion Criteria:
- Systolic blood pressure (SBP)>180mmHg
- Diastolic blood pressure (DBP)>120mmHg
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Control group
|
|
|
Observation 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.
|
|
Positive control group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
creatinine
Time Frame: 2023-12-01 to 2024-12-31
|
creatinine levels of enrolled patients
|
2023-12-01 to 2024-12-31
|
|
urea nitrogen
Time Frame: 2023-12-01 to 2024-12-31
|
urea nitrogen levels of enrolled patients
|
2023-12-01 to 2024-12-31
|
|
blood pressure
Time Frame: 2023-12-01 to 2024-12-31
|
Both systolic and diastolic Blood Pressure levels of enrolled patients
|
2023-12-01 to 2024-12-31
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
February 1, 2024
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
January 2, 2024
First Submitted That Met QC Criteria
January 2, 2024
First Posted (Actual)
January 11, 2024
Study Record Updates
Last Update Posted (Actual)
January 22, 2024
Last Update Submitted That Met QC Criteria
January 19, 2024
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AH-2023-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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