Steroids on Intra-dialytic Hypotension

Sponsor

University of Jordan (Other)

Overall Status

Completed

CT.gov ID

NCT03465007

Collaborator

(none)

Enrollment

Location

Arms

15.3

Actual Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dialysis Hypotension	Drug: Hydrocortisone Drug: Normal saline	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

82 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Prevention

Official Title:

Effects of Corticosteroids on Intra-dialytic Hypotension

Actual Study Start Date :

Oct 22, 2017

Actual Primary Completion Date :

Jul 25, 2018

Actual Study Completion Date :

Feb 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Hydrocortisone 100mg Hydrocortisone will be administered prior to hemodialysis	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.
Placebo Comparator: Placebo 100mg normal saline will be administered prior to hemodialysis	Drug: 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

Arm

Intervention/Treatment

Active Comparator: Hydrocortisone

100mg Hydrocortisone will be administered prior to hemodialysis

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.

Placebo Comparator: Placebo

100mg normal saline will be administered prior to hemodialysis

Drug: 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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Patients on hemodialysis who develop intra-dialytic hypotension.

Exclusion Criteria:

Adrenal insufficiency

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	School of Medicine	Amman		Jordan	11942

Sponsors and Collaborators

University of Jordan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Saif Aldeen AlRyalat, Researcher, University of Jordan

ClinicalTrials.gov Identifier:

NCT03465007

Other Study ID Numbers:

JUH2018_3

First Posted:

Mar 14, 2018

Last Update Posted:

Apr 8, 2019

Last Verified:

Apr 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Saif Aldeen AlRyalat, Researcher, University of Jordan

hemodialysis

cortisol

Hydrocortisone

Additional relevant MeSH terms:

Hypotension

Hydrocortisone

Study Results

No Results Posted as of Apr 8, 2019