Dialysis HypotensionNCT03465007
Steroids on Intra-dialytic Hypotension
A study testing Hydrocortisone and Normal saline in people with Dialysis Hypotension, run by University of Jordan at 1 site in Jordan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dialysis Hypotension
- What is being tested?
- Hydrocortisone and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteJordan
- Study dates
- 22 Oct 2017to 1 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients on hemodialysis who develop intra-dialytic hypotension.
Who cannot join
- Adrenal insufficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Corticosteroids 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.
- Conditions
- Dialysis Hypotension
- Being tested
- Hydrocortisone, Normal saline
- Keywords
- hemodialysis, cortisol, Hydrocortisone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrocortisoneDrug
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 salineDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Hydrocortisone | Active comparator | 100mg Hydrocortisone will be administered prior to hemodialysis Receives: Drug: Hydrocortisone |
| Placebo | Placebo comparator | 100mg normal saline will be administered prior to hemodialysis Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start22 Oct 2017
- Primary completion25 Jul 2018
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dialysis HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saif Aldeen AlRyalat, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03465007
- Sponsor's protocol ID
- JUH2018_3
- Status last verified
- Apr 2019
- First submitted
- 6 Mar 2018
- Last updated
- 8 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34901264
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Corticosteroids on Intra-dialytic Hypotension
- ClinicalTrials.gov ID
- NCT03465007
- Acronym / sponsor ID
- JUH2018_3
- Conditions
- Dialysis Hypotension
- Keywords
- hemodialysis, cortisol, Hydrocortisone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 22 Oct 2017 (actual)
- Primary completion
- 25 Jul 2018 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 14 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrocortisone | Active comparator | Drug: Hydrocortisone100mg Hydrocortisone will be administered prior to hemodialysis |
| Placebo | Placebo comparator | Drug: Normal saline100mg normal saline will be administered prior to hemodialysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients on hemodialysis who develop intra-dialytic hypotension.
Key exclusion criteria (1 listed)
- Adrenal insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrocortisonewe 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. | Drug | Hydrocortisone |
| Normal salinewe 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 | Drug | Placebo |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2019.
- Derived from this study: PubMed 34901264Alhawari 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrocortisone and Normal saline in people with Dialysis Hypotension, run by University of Jordan at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-dialytic hypotension (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03465007, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2019.