Acute Kidney InjuryNCT03431194
Midodrine is Effective in Management of Intradialytic Hypotension Among Critically-ill Patients With Acute Kidney Injury
A study testing midodrine in people with Acute Kidney Injury, run by Benha University.
Trial summary
The aim of this randomized trial was to assess the efficacy of oral midodrine tablets for the management of intradialytic hypotension among critically ill patients with acute kidney injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- midodrine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2016to 6 Apr 2017
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ICU patients
- acute kidney injury
- age above 18 years
- documented hypotension during dialysis
Who cannot join
- packed red blood cells transfusion
- intravenous inotropes
- alteration of blood pressure medications
About this study
The aim of this randomized trial was to assess the efficacy of oral midodrine tablets for the management of intradialytic hypotension among critically ill patients with acute kidney injury.
Read the detailed description
In This open -label study, patients in ICU with acute kidney injury are randomized to either midodrine tablets or placebo. the number of intradialytic episodes and both systolic and diastolic blood pressure between both groups are compared. Mortality and adverse effects are monitored and compared as well.
- Conditions
- Acute Kidney Injury
- Being tested
- midodrine, Placebo
- Keywords
- Acute Kidney Injury, midodrine, intensive care unit
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
midodrineDrug
oral midodrine tablets 5 mg
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| midodrine group | Active comparator | Patients will receive midodrine tablets Receives: Drug: midodrine |
| placebo group | Placebo comparator | Patients receive sugary oral tablets therapy Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of hypotensive episodes
Number of hypotensive episodes
Measured: 30 days from start of hemodialysis
Secondary outcomes (3)
mean systolic blood pressure
compare mean systolic blood pressure between the two arms
Measured: 30 days from start of hemodialysis
mean diastolic blood pressure
compare mean diastolic blood pressure between the two arms
Measured: 30 days from start of hemodialysis
Mortality in each arm
Number of dead patients in each arm
Measured: 30 days from start of hemodialysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start1 Oct 2016
- Primary completion19 Feb 2017
- Study completion6 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Collaborators
- New Jeddah Clinic Hospital
- Responsible party
- Principal investigator, Mahmoud Hamada imam, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03431194
- Sponsor's protocol ID
- BN-14716
- Status last verified
- Aug 2022
- First submitted
- 7 Feb 2018
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Midodrine is Effective in Management of Intradialytic Hypotension Among Critically-ill Patients With Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT03431194
- Acronym / sponsor ID
- BN-14716
- Conditions
- Acute Kidney Injury
- Keywords
- Acute Kidney Injury, midodrine, intensive care unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Collaborators
- New Jeddah Clinic Hospital
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 19 Feb 2017 (actual)
- Study completion
- 6 Apr 2017 (actual)
- First posted
- 13 Feb 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.
The aim of this randomized trial was to assess the efficacy of oral midodrine tablets for the management of intradialytic hypotension among critically ill patients with acute kidney injury.
Detailed description
In This open -label study, patients in ICU with acute kidney injury are randomized to either midodrine tablets or placebo. the number of intradialytic episodes and both systolic and diastolic blood pressure between both groups are compared. Mortality and adverse effects are monitored and compared as well.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| midodrine group | Active comparator | Drug: midodrinePatients will receive midodrine tablets |
| placebo group | Placebo comparator | Drug: PlaceboPatients receive sugary oral tablets therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ICU patients
- acute kidney injury
- age above 18 years
- documented hypotension during dialysis
Key exclusion criteria (3 listed)
- packed red blood cells transfusion
- intravenous inotropes
- alteration of blood pressure medications
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 |
|---|---|---|
| midodrineoral midodrine tablets 5 mg | Drug | midodrine group |
| Placebo | Drug | placebo group |
Primary outcome
Number of hypotensive episodes
Time frame: 30 days from start of hemodialysis
Number of hypotensive episodes
3 secondary outcomes
mean systolic blood pressure
Time frame: 30 days from start of hemodialysis
mean diastolic blood pressure
Time frame: 30 days from start of hemodialysis
Mortality in each arm
Time frame: 30 days from start of hemodialysis
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 22 Aug 2022.
- Individual participant dataSharing planned: No
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Acute Kidney Injury, Hypotension (MeSH: D007022)
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.
Questions about this trial
What is this clinical trial studying?
A study testing midodrine in people with Acute Kidney Injury, run by Benha University.
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 4 inclusion and 3 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 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of hypotensive episodes (time frame: 30 days from start of hemodialysis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2022.