Steroids on Intra-dialytic Hypotension

NCT ID: NCT03465007

Last Updated: 2019-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-22
• Study Completion Date: 2019-02-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Hydrocortisone

100mg Hydrocortisone will be administered prior to hemodialysis

Group Type: ACTIVE_COMPARATOR

Hydrocortisone

Intervention Type: 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.

Placebo

100mg normal saline will be administered prior to hemodialysis

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: 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

Interventions

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.

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients on hemodialysis who develop intra-dialytic hypotension.

Exclusion Criteria

• Adrenal insufficiency

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Jordan

OTHER

Sponsor Role: lead

Responsible Party

Saif Aldeen AlRyalat

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

School of Medicine

Amman, , Jordan

Countries

Jordan

References

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.

Reference Type: DERIVED

PMID: 34901264 (View on PubMed)

Other Identifiers

JUH2018_3

Identifier Type: -

Identifier Source: org_study_id