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Steroids on Intra-dialytic Hypotension

Primary Purpose

Dialysis Hypotension

Status
Completed
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
Hydrocortisone
Normal saline
Sponsored by
University of Jordan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dialysis Hypotension focused on measuring hemodialysis, cortisol, Hydrocortisone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients on hemodialysis who develop intra-dialytic hypotension.

Exclusion Criteria:

  • Adrenal insufficiency

Sites / Locations

  • School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Hydrocortisone

Placebo

Arm Description

100mg Hydrocortisone will be administered prior to hemodialysis

100mg normal saline will be administered prior to hemodialysis

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 6, 2018
Last Updated
April 4, 2019
Sponsor
University of Jordan
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1. Study Identification

Unique Protocol Identification Number
NCT03465007
Brief Title
Steroids on Intra-dialytic Hypotension
Official Title
Effects of Corticosteroids on Intra-dialytic Hypotension
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
October 22, 2017 (Actual)
Primary Completion Date
July 25, 2018 (Actual)
Study Completion Date
February 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jordan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dialysis Hypotension
Keywords
hemodialysis, cortisol, Hydrocortisone

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hydrocortisone
Arm Type
Active Comparator
Arm Description
100mg Hydrocortisone will be administered prior to hemodialysis
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
100mg normal saline will be administered prior to hemodialysis
Intervention Type
Drug
Intervention Name(s)
Hydrocortisone
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
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 Outcome Measure Information:
Title
Intra-dialytic hypotension
Description
intradialytic hypotension as the presence of a decrease in systolic blood pressure ≥20 mmHg or a decrease in mean arterial pressure by 10 mmHg.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients on hemodialysis who develop intra-dialytic hypotension. Exclusion Criteria: Adrenal insufficiency
Facility Information:
Facility Name
School of Medicine
City
Amman
ZIP/Postal Code
11942
Country
Jordan

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34901264
Citation
Alhawari HH, Alshelleh S, Alhawari HH, Alawwa IA, AlRyalat SA, Mesmar A, Ojjoh K, Alzoubi KH. Effect of Hydrocortisone on Intradialytic Hypotension: A Preliminary Investigational Study. Biomed Res Int. 2020 May 5;2020:4987547. doi: 10.1155/2020/4987547. eCollection 2020.
Results Reference
derived

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Steroids on Intra-dialytic Hypotension

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