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OpenTrials
Completed

NCT Number: NCT03465007

Steroids on Intra-dialytic Hypotension

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Medicine

Amman, 11942, Jordan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients on hemodialysis who develop intra-dialytic hypotension.

Exclusion criteria

  • Adrenal insufficiency

Treatment and study plan

Hydrocortisone

Drug

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

Drug

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

Primary outcomes

  1. Intra-dialytic hypotension

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Jordan

Other

Registry information

Official study title

Effects of Corticosteroids on Intra-dialytic Hypotension

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Mar 14, 2018
Registry last updated
Apr 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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