Steroids on Intra-dialytic Hypotension

NCT03465007 | Completed DMC

• 1 other identifier: JUH2018_3
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Dialysis Hypotension

Keywords

hemodialysis; cortisol; Hydrocortisone

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Study Arms (2)

Hydrocortisone

ACTIVE COMPARATOR

100mg Hydrocortisone will be administered prior to hemodialysis

Drug: Hydrocortisone

Placebo

PLACEBO COMPARATOR

100mg normal saline will be administered prior to hemodialysis

Drug: Normal saline

Interventions

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.

Hydrocortisone

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients on hemodialysis who develop intra-dialytic hypotension.

You may not qualify if:

• Adrenal insufficiency

Sponsors & Collaborators

• University of Jordan: lead

Study Sites (1)

School of Medicine

Amman, 11942, Jordan

Location

Related Publications (1)

• 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.

  PMID: 34901264 DERIVED

MeSH Terms

Interventions

Hydrocortisone; Saline Solution

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: March 6, 2018
• First Posted: March 14, 2018
• Study Start: October 22, 2017
• Primary Completion: July 25, 2018
• Study Completion: February 1, 2019
• Last Updated: April 8, 2019

Record last verified: 2019-04

Locations

JO (1)