IDH in Diabetic Haemodialysis Patients and Association With Dialytic Age

Intra-dialytic Hypotension Clinical Trial

Official title:

Intradialytic Hypotension in Diabetic Haemodialysis Patients and Its Association With Dialytic Age

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03870594
• Other study ID #: IDH in diabetic patients
• Status: Not yet recruiting
• Start date: April 2019
• Est. completion date: July 2019

Study information

• Verified date: March 2019
• Source: Assiut University
• Contact: Mahmoud fawzy
• Phone: 201276366168
• Email: mahmoudfawzy2490[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: July 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

All haemodialysed end stage kidney disease patients of the haemodialysis unit in Assiut health insurance hospital

Exclusion Criteria:

• 1-Advanced heart failure 2-Clinical instability requiring hospital admission. 3-History of alcohol or substance abuse 4-previous history of psychotic disorders

Related Conditions & MeSH terms

• Hypotension
• Intra-dialytic Hypotension

Intervention

Diagnostic Test:
• glycated hemoglobin
hemoglobin A1c level in blood

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mahmoud Mohamed Fawzy

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4 weeks
Primary	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	4 weeks