COVID-19NCT05212675
Short Daily Versus Conventional Hemodialysis for COVID-19 Patients
A study testing Short daily dialysis in people with COVID-19, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
Treatment of dialysis patients involved with COVID-19 with short daily hemodialysis has been supposed to improve short term outcome. It is unclear if short daily dialysis would optimize mortality or ICU admission in routine dialysis patients with COVID-19. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19
- What is being tested?
- Short daily dialysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteIran
- Study dates
- 1 Mar 2021to 30 Aug 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ESRD patients >3months on hemodialysis admitted for COVID-19
Who cannot join
- ESRD patients <3 months on hemodialysis infected with COVID-19
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short Daily Versus Conventional Hemodialysis for COVID-19 Patients: A Randomized Study
Treatment of dialysis patients involved with COVID-19 with short daily hemodialysis has been supposed to improve short term outcome. It is unclear if short daily dialysis would optimize mortality or ICU admission in routine dialysis patients with COVID-19.
Also the potential variants according with worse outcomes remain to be fully elucidated.
Read the detailed description
investigators undertook a randomized trial in ESRD patients infected with COVID-19 to determine: 1) if short-daily hemodialysis is associated with a reduction in mortality and ICU admission in one weak period and; 2) the potential effective variants in worst outcome. . Paperwork for the trial was submitted to the shaheed beheshti university of medical sciences in June 2021 for registration . The protocol for this trial and supporting CONSORT checklist are available. The SBMU Ethics Board approved the study and all amendments. The study was conducted according to the Declaration of Helsinki.
- Conditions
- COVID-19
- Being tested
- Short daily dialysis
- Keywords
- Dialysis
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short daily dialysisOther
7 days 2hours dialysis
| Study group | Role | What they receive |
|---|---|---|
| short daily dialysis | Other | 7 days 2hours dialysis Receives: Other: Short daily dialysis |
| conventional dialysis | No intervention | 3 times weekly 4hours dialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
discharged or dead
Measured: From date of randomization until the date of first documented progression or date of death
ICU add
admission to ICU or not
Measured: From date of randomization until the date of first documented progression or date of death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start1 Mar 2021
- Primary completion1 Jun 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, nooshin dalili, Shahid Beheshti University of Medical Sciences
- Investigators
- Nooshin Dalili, MD, Principal investigator, SBMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05212675
- Sponsor's protocol ID
- SBMU-1400-10
- Status last verified
- Jan 2022
- First submitted
- 24 Jan 2022
- Last updated
- 28 Jan 2022
- Results posted
- No
- 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 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Daily Versus Conventional Hemodialysis for COVID-19 Patients: A Randomized Study
- ClinicalTrials.gov ID
- NCT05212675
- Acronym / sponsor ID
- SBMU-1400-10
- Conditions
- COVID-19
- Keywords
- Dialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 28 Jan 2022 (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.
Treatment of dialysis patients involved with COVID-19 with short daily hemodialysis has been supposed to improve short term outcome. It is unclear if short daily dialysis would optimize mortality or ICU admission in routine dialysis patients with COVID-19.
Also the potential variants according with worse outcomes remain to be fully elucidated.
Detailed description
investigators undertook a randomized trial in ESRD patients infected with COVID-19 to determine: 1) if short-daily hemodialysis is associated with a reduction in mortality and ICU admission in one weak period and; 2) the potential effective variants in worst outcome. . Paperwork for the trial was submitted to the shaheed beheshti university of medical sciences in June 2021 for registration . The protocol for this trial and supporting CONSORT checklist are available. The SBMU Ethics Board approved the study and all amendments. The study was conducted according to the Declaration of Helsinki.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| short daily dialysis | Other | Other: Short daily dialysis7 days 2hours dialysis |
| conventional dialysis | No intervention | –3 times weekly 4hours dialysis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- ESRD patients >3months on hemodialysis admitted for COVID-19
Key exclusion criteria (1 listed)
- ESRD patients <3 months on hemodialysis infected with COVID-19
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 |
|---|---|---|
| Short daily dialysis7 days 2hours dialysis | Other | short daily dialysis |
Primary outcome
Mortality
Time frame: From date of randomization until the date of first documented progression or date of death
discharged or dead
ICU add
Time frame: From date of randomization until the date of first documented progression or date of death
admission to ICU or not
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 28 Jan 2022.
- Individual participant dataSharing planned: No
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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.
Nooshin Dalili, MD principal investigator
SBMU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short daily dialysis in people with COVID-19, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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 28 Jan 2022. 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 Iran. 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. 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?
Mortality (time frame: From date of randomization until the date of first documented progression or date of death). The study lists 2 primary outcomes in all. 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 28 Jan 2022.