Steroids on Intra-dialytic Hypotension

Dialysis Hypotension Clinical Trial

Official title:

Effects of Corticosteroids on Intra-dialytic Hypotension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03465007
• Other study ID #: JUH2018_3
• Status: Completed
• Phase: N/A
• Start date: October 22, 2017
• Est. completion date: February 1, 2019

Study information

• Verified date: April 2019
• Source: University of Jordan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Symptomatic hypotension during (or immediately following) hemodialysis complicates 5 to 30 percent of all dialysis treatments and is associated with increased morbidity and mortality. Kidney Disease Outcomes Quality Initiative (KDOQI) and European Best Practice Guidelines define intradialytic hypotension as the presence of a decrease in systolic blood pressure ≥20 mmHg or a decrease in mean arterial pressure by 10 mmHg, providing the decrease in blood pressure is associated with clinical events and need for nursing interventions. Common causes of intradialytic hypotension include excessive or rapid ultrafiltration, high blood flow during dialysis, CHF, taking the antihypertensive medications prior to HD, and others. One of the possible reasons that is surprisingly has not been approached worldwide for intra-dialytic hypotension could be more prevalent adrenal insufficiency in ESRD patients or a delay in the appropriate rise of endogenous serum cortisol given hemodialysis is considered by all means a stressful condition to the body. Investigators will assess first the prevalence of intradialytic hypotension at JUH dialysis unit. Investigators will screen patients who developed intradialytic hypotension for adrenal insufficiency by ordering random am cortisol. Then Investigators will give IV Hydrocortisone 100 mg prior to HD to patients who developed intra-dialytic hypotension and monitor their BP response during the HD treatments for 3 HD sessions (1 week, 3 HD sessions). After that, the same patients will receive 100 mg normal saline for 3 HD sessions. Both the administrator and the patient will be blinded for the interventions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: February 1, 2019
• Est. primary completion date: July 25, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients on hemodialysis who develop intra-dialytic hypotension.

Exclusion Criteria:

• Adrenal insufficiency

Related Conditions & MeSH terms

• Dialysis Hypotension
• Hypotension

Intervention

Drug:
• Hydrocortisone
we will give IV Hydrocortisone 100 mg prior to HD to the patients who developed intra-dialytic hypotension and monitor their BP response during the HD treatments.
• Normal saline
we will give IV normal saline 100 mg prior to HD to the patients who developed intra-dialytic hypotension and monitor their BP response during the HD

Locations

Country	Name	City	State
Jordan	School of Medicine	Amman

Sponsors (1)

Lead Sponsor	Collaborator
University of Jordan

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intra-dialytic hypotension	intradialytic hypotension as the presence of a decrease in systolic blood pressure =20 mmHg or a decrease in mean arterial pressure by 10 mmHg.	3 months