Intra-dialytic HypotensionNCT03870594
IDH in Diabetic Haemodialysis Patients and Association With Dialytic Age
An observational study of Intra-dialytic Hypotension, run by Mahmoud Mohamed Fawzy.
Trial summary
Intradialytic hypotension (IDH ) is a serious and the most frequent complication of hemodialysis of the hemodialysis .Diabetes is associated with autonomic neuropathy which contribute to intradialytic hypotension Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Intra-dialytic Hypotension
- What is being tested?
- glycated hemoglobin
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Apr 2019to Jul 2019
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: all haemodialysed end stage kidney disease patients of the haemodialysis unit in Assiut health insurance hospital
Who may be able to join
- All haemodialysed end stage kidney disease patients of the haemodialysis unit in Assiut health insurance hospital
Who cannot join
- 1-Advanced heart failure 2-Clinical instability requiring hospital admission. 3-History of alcohol or substance abuse 4-previous history of psychotic disorders
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Intradialytic Hypotension in Diabetic Haemodialysis Patients and Its Association With Dialytic Age
Intradialytic hypotension (IDH ) is a serious and the most frequent complication of hemodialysis of the hemodialysis .Diabetes is associated with autonomic neuropathy which contribute to intradialytic hypotension
Read the detailed description
Intradialytic hypotension (IDH ) is a serious and the most frequent complication of hemodialysis of the hemodialysis.Intradialytic hypotension is a decrease in systolic BP by ≥20 mm Hg or a decrease in mean arterial pressure of 10 mm Hg associated with symptoms like cramps, dizziness, headache ,nausea and vomiting according to The National Kidney Foundation.Intradialytic hypotension occurs during 20%-30% of hemodialysis sessions. It is associated with poor long-term outcomes. Patients with Intradialytic hypotension show increased morbidity and mortality.The etiology of Intradialytic hypotension is multifactorial and depends on patient-related factors, as well as on complications related to the dialysis procedure. The main causes Intradialytic hypotension have been reported to be acute hypovolemia during ultrafiltration and inadequate compensatory mechanisms such as left ventricular dysfunction, inappropriate plasma refilling ,Impaired vasoconstriction induced by dysregulation of autonomic nervous system.
Diabetes mellitus is the most common cause of chronic renal failure .Diabetic patients are more prone to cardiovascular diseases than non-diabetics .Although diabetes is in relation with hypertension ,It is associated with autonomic neuropathy which contribute to intradialytic hypotension . Recent researches suggested that older age and long dialytic age may incease risk of intradialytic hypotension.
- Conditions
- Intra-dialytic Hypotension
- Being tested
- glycated hemoglobin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glycated hemoglobinDiagnostic test
hemoglobin A1c level in blood
| Study group | Role | What they receive |
|---|---|---|
| diabetic | patients suffer from diabetes mellitus Receives: Diagnostic Test: glycated hemoglobin | |
| non diabetic | patients free from diabetes with normal blood glucose level Receives: Diagnostic Test: glycated hemoglobin |
What is being measured
The primary outcome is the main question the study is designed to answer.
the correlation between diabetes and intradialytic hypotension
Blood samples will be obtained for glycated hemoglobin, fasting blood glucose.Then patients will be divided into two groups DM, non DM.
Blood pressure will be measured with mercury sphygmomanometer before, after and every 60 min during the hemodialysis session (a total of 5 measurements), for 10 consecutive dialysis sessions.Intradialytic hypotension (IDH) will defined as a decrease in systolic BP by ≥20 mm Hg or a decrease in mean arterial pressure of 10 mm Hg associated with symptoms
Measured: 4 weeks
the correlation between dialytic age and intradialytic hypotension
Prior to the dialysis session,full history taking including age,duration of haemodialysis Blood pressure (BP) will be measured with mercury sphygmomanometer before, after and every 60 min during the hemodialysis session (a total of 5 measurements), for 10 consecutive dialysis sessions.
Intradialytic hypotension (IDH) will defined as a decrease in systolic BP by ≥20 mm Hg or a decrease in mean arterial pressure of 10 mm Hg associated with symptoms
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study startApr 2019 (estimated)
- Primary completionJun 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intra-dialytic 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
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahmoud Mohamed Fawzy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mahmoud Mohamed Fawzy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03870594
- Sponsor's protocol ID
- IDH in diabetic patients
- Status last verified
- Mar 2019
- First submitted
- 5 Mar 2019
- Last updated
- 12 Mar 2019
- 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 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intradialytic Hypotension in Diabetic Haemodialysis Patients and Its Association With Dialytic Age
- ClinicalTrials.gov ID
- NCT03870594
- Acronym / sponsor ID
- IDH in diabetic patients
- Conditions
- Intra-dialytic Hypotension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Mahmoud Mohamed FawzyUniversity, hospital or other
- Study start
- Apr 2019 (estimated)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 12 Mar 2019 (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.
Intradialytic hypotension (IDH ) is a serious and the most frequent complication of hemodialysis of the hemodialysis .Diabetes is associated with autonomic neuropathy which contribute to intradialytic hypotension
Detailed description
Intradialytic hypotension (IDH ) is a serious and the most frequent complication of hemodialysis of the hemodialysis.Intradialytic hypotension is a decrease in systolic BP by ≥20 mm Hg or a decrease in mean arterial pressure of 10 mm Hg associated with symptoms like cramps, dizziness, headache ,nausea and vomiting according to The National Kidney Foundation.Intradialytic hypotension occurs during 20%-30% of hemodialysis sessions. It is associated with poor long-term outcomes. Patients with Intradialytic hypotension show increased morbidity and mortality.The etiology of Intradialytic hypotension is multifactorial and depends on patient-related factors, as well as on complications related to the dialysis procedure. The main causes Intradialytic hypotension have been reported to be acute hypovolemia during ultrafiltration and inadequate compensatory mechanisms such as left ventricular dysfunction, inappropriate plasma refilling ,Impaired vasoconstriction induced by dysregulation of autonomic nervous system.
Diabetes mellitus is the most common cause of chronic renal failure .Diabetic patients are more prone to cardiovascular diseases than non-diabetics .Although diabetes is in relation with hypertension ,It is associated with autonomic neuropathy which contribute to intradialytic hypotension . Recent researches suggested that older age and long dialytic age may incease risk of intradialytic hypotension.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diabetic | – | Diagnostic Test: glycated hemoglobinpatients suffer from diabetes mellitus |
| non diabetic | – | Diagnostic Test: glycated hemoglobinpatients free from diabetes with normal blood glucose level |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- all haemodialysed end stage kidney disease patients of the haemodialysis unit in Assiut health insurance hospital
Key inclusion criteria (1 listed)
- All haemodialysed end stage kidney disease patients of the haemodialysis unit in Assiut health insurance hospital
Key exclusion criteria (1 listed)
- 1-Advanced heart failure 2-Clinical instability requiring hospital admission. 3-History of alcohol or substance abuse 4-previous history of psychotic disorders
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 |
|---|---|---|
| glycated hemoglobinhemoglobin A1c level in blood | Diagnostic test | diabetic, non diabetic |
Primary outcome
the correlation between diabetes and intradialytic hypotension
Time frame: 4 weeks
Blood samples will be obtained for glycated hemoglobin, fasting blood glucose.Then patients will be divided into two groups DM, non DM. Blood pressure will be measured with mercury sphygmomanometer before, after and every 60 min during the hemodialysis session (a total of 5 measurements), for 10 consecutive dialysis sessions.Intradialytic hypotension (IDH) will defined as a decrease in systolic BP by ≥20 mm Hg or a decrease in mean arterial pressure of 10 mm Hg associated with symptoms
the correlation between dialytic age and intradialytic hypotension
Time frame: 4 weeks
Prior to the dialysis session,full history taking including age,duration of haemodialysis Blood pressure (BP) will be measured with mercury sphygmomanometer before, after and every 60 min during the hemodialysis session (a total of 5 measurements), for 10 consecutive dialysis sessions. Intradialytic hypotension (IDH) will defined as a decrease in systolic BP by ≥20 mm Hg or a decrease in mean arterial pressure of 10 mm Hg associated with symptoms
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2019.
Related trials for Intra-dialytic Hypotension
Recruiting
Trial of Variable Dialysate Bicarbonate
Peri-dialytic Cardiac Rhythms, Intradialytic Hypotension
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Intra-dialytic Hypotension, run by Mahmoud Mohamed Fawzy.
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 1 inclusion and 1 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 12 Mar 2019. 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?
Contact Mahmoud fawzy (201276366168, mahmoudfawzy2490@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the correlation between diabetes and intradialytic hypotension (time frame: 4 weeks). The study lists 2 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 12 Mar 2019.