Steroids on Intra-dialytic Hypotension

Not Applicable

Completed

• Conditions: Dialysis Hypotension
• Interventions: Drug: Normal saline; Drug: Hydrocortisone

• Registration Number: NCT03465007
• Lead Sponsor: University of Jordan

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-22
• Study First Submitted: 2018-03-06
• Study First Submitted QC: 2018-03-12
• Study First Posted: 2018-03-14
• Primary Completion: 2018-07-25
• Study Completion: 2019-02-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-04
• Last Update Posted: 2019-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

• Patients on hemodialysis who develop intra-dialytic hypotension.

Exclusion Criteria

• Adrenal insufficiency

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Normal saline	100mg normal saline will be administered prior to hemodialysis
Hydrocortisone	Hydrocortisone	100mg Hydrocortisone will be administered prior to hemodialysis

Primary Outcome Measures

Name	Time	Method
Intra-dialytic hypotension	3 months	intradialytic hypotension as the presence of a decrease in systolic blood pressure ≥20 mmHg or a decrease in mean arterial pressure by 10 mmHg.

Trial Locations

Locations (1)

School of Medicine; 🇯🇴 Amman, Jordan