Effects of Corticosteroids on Intra-dialytic Hypotension
Hydrocortisone
+ Normal saline
Prevention Study
Summary
Study start date: October 22, 2017
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.82 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
Active ComparatorGroup II
PlaceboStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location