Renal Replacement TherapyNCT04512131
Impact of Dialysis Modality on Coagulation and Platelet Function
An observational study of Renal Replacement Therapy, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The investigators will evaluate the impact of dialysis modality (intermittent hemodialysis or continuous renal replacement therapy) in coagulation and platelet function in critically ill patients Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Renal Replacement Therapy
- What is being tested?
- dialysis mode
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Aug 2020to 30 Jun 2023
- How long will I take part?
- 2 Days
- Phase
- Observational
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: critically ill adult patients in surgical intensive care unit requiring renal replacement therapy
Who may be able to join
- Critically ill adult patients in surgical intensive care unit who require renal replacement therapy
Who cannot join
- Patients treated with anti-coagulation therapy due to thrombosis/embolism
- Patients who take anti-platelet drug due to cardiac or cerebrovascular diseased
- Patients treated with pharmacological prophylaxis of deep vein thrombosis
- Patients who received blood products within 24 hours of dialysis initiation
- Patients who do not want life-sustaining care including renal replacement therapy
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Jongno-gu, 03080
About this study
Official title: Impact of Dialysis Modality on Coagulation and Platelet Function in Critically Ill Patients: Intermittent Hemodialysis vs. Continuous Renal Replacement Therapy
The investigators will evaluate the impact of dialysis modality (intermittent hemodialysis or continuous renal replacement therapy) in coagulation and platelet function in critically ill patients
Read the detailed description
An prospective observational study will be conducted to confirm the impact of two dialysis modalitites on coagulation and platelet function in critically ill patients requiring renal replacement therapy using laboratory test, Multiplate and ROTEM.
- Conditions
- Renal Replacement Therapy
- Being tested
- dialysis mode
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dialysis modeProcedure or surgery
intermittent hemodialysis or continuous renal replacement therapy
| Study group | Role | What they receive |
|---|---|---|
| Intermittent hemodialysis | patients who are going to undergo intermittent hemodialysis or patients who are going to switch dialysis mode to intermittent hemodialysis from continuous renal replacement therapy Laboratory test including complete blood count, prothrombin time, activated partial thromboplastin time, protein C, protein S and D-dimer, EXTEM of ROTEM and Multiplate® platelet function analysis will be checked just before dialysis initiation and immediately after dialysis termination Receives: Procedure: dialysis mode | |
| continuous renal replacement therapy | patients who are going to undergo continuous renal replacement therapy Laboratory test including complete blood count, prothrombin time, activated partial thromboplastin time, protein C, protein S and D-dimer, EXTEM of ROTEM and Multiplate platelet function analysis will be checked within 24 hours after dialysis initiation and 48 hours after taking first blood sample Receives: Procedure: dialysis mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
clotting time (CT) in EXTEM in rotational thromboelastometry (ROTEM)
the difference of changes in CT in EXTEM of ROTEM (seconds)
Measured: before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy
Secondary outcomes (15)
Multiplate® platelet function analysis area under curve unit
the difference of platelet function using Multiplate®
Measured: before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy
clot formation time (CFT) in EXTEM
the difference of CFT in EXTEM using ROTEM (seconds)
Measured: before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy
Amplitude 10 minutes after CT (A10) in EXTEM
the difference of A10 in EXTEM using ROTEM (mm)
Measured: before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy
α-angle in EXTEM
the difference of α-angle in EXTEM using ROTEM (º)
Measured: before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy
Maximal clot firmness (MCF) in EXTEM
the difference of MCF in EXTEM using ROTEM (mm)
Measured: before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy
prothrombin time
the difference of prothrombin time (seconds)
Measured: before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy
activated partial thromboplastin time
the difference of activated partial thromboplastin time (seconds)
Measured: before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy
Protein C
the difference of Protein C
Measured: before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy
Protein S
the difference of Protein S
Measured: before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy
fibrinogen
the difference of fibrinogen
Measured: before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy
D-dimer
the difference of D-dimer
Measured: before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy
platelet count
the difference of platelet count
Measured: before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy
the amount of blood transfusion
the amount of blood transfusion for 24 hours after taking second blood sample
Measured: 24 hours
hemodynamic changes
changes of mean arterial pressure > 20 %, increased vasopressor/inotropics
Measured: 24 hours
changes of characteristics or amount of drainage
changes of characteristics or amount of drainage
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start4 Aug 2020
- Primary completion27 Feb 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Replacement TherapyStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ho Geol Ryu, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04512131
- Sponsor's protocol ID
- Dialysis mode_coagulation
- Status last verified
- Dec 2023
- First submitted
- 4 Aug 2020
- Last updated
- 28 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Dialysis Modality on Coagulation and Platelet Function in Critically Ill Patients: Intermittent Hemodialysis vs. Continuous Renal Replacement Therapy
- ClinicalTrials.gov ID
- NCT04512131
- Acronym / sponsor ID
- Dialysis mode_coagulation
- Conditions
- Renal Replacement Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 4 Aug 2020 (actual)
- Primary completion
- 27 Feb 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 13 Aug 2020 (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 investigators will evaluate the impact of dialysis modality (intermittent hemodialysis or continuous renal replacement therapy) in coagulation and platelet function in critically ill patients
Detailed description
An prospective observational study will be conducted to confirm the impact of two dialysis modalitites on coagulation and platelet function in critically ill patients requiring renal replacement therapy using laboratory test, Multiplate and ROTEM.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent hemodialysis | – | Procedure: dialysis modepatients who are going to undergo intermittent hemodialysis or patients who are going to switch dialysis mode to intermittent hemodialysis from continuous renal replacement therapy Laboratory test including complete blood count, prothrombin time, activated partial thromboplastin time, protein C, protein S and D-dimer, EXTEM of ROTEM and Multiplate® platelet function analysis will be checked just before dialysis initiation and immediately after dialysis termination |
| continuous renal replacement therapy | – | Procedure: dialysis modepatients who are going to undergo continuous renal replacement therapy Laboratory test including complete blood count, prothrombin time, activated partial thromboplastin time, protein C, protein S and D-dimer, EXTEM of ROTEM and Multiplate platelet function analysis will be checked within 24 hours after dialysis initiation and 48 hours after taking first blood sample |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- critically ill adult patients in surgical intensive care unit requiring renal replacement therapy
Key inclusion criteria (1 listed)
- Critically ill adult patients in surgical intensive care unit who require renal replacement therapy
Key exclusion criteria (5 listed)
- Patients treated with anti-coagulation therapy due to thrombosis/embolism
- Patients who take anti-platelet drug due to cardiac or cerebrovascular diseased
- Patients treated with pharmacological prophylaxis of deep vein thrombosis
- Patients who received blood products within 24 hours of dialysis initiation
- Patients who do not want life-sustaining care including renal replacement therapy
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 |
|---|---|---|
| dialysis modeintermittent hemodialysis or continuous renal replacement therapy | Procedure or surgery | Intermittent hemodialysis, continuous renal replacement therapy |
Primary outcome
clotting time (CT) in EXTEM in rotational thromboelastometry (ROTEM)
Time frame: before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy
the difference of changes in CT in EXTEM of ROTEM (seconds)
15 secondary outcomes
Multiplate® platelet function analysis area under curve unit
Time frame: before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy
clot formation time (CFT) in EXTEM
Time frame: before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy
Amplitude 10 minutes after CT (A10) in EXTEM
Time frame: before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy
α-angle in EXTEM
Time frame: before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy
Maximal clot firmness (MCF) in EXTEM
Time frame: before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy
prothrombin time
Time frame: before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy
activated partial thromboplastin time
Time frame: before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy
Protein C
Time frame: before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy
Protein S
Time frame: before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy
fibrinogen
Time frame: before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy
D-dimer
Time frame: before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy
platelet count
Time frame: before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy
the amount of blood transfusion
Time frame: 24 hours
hemodynamic changes
Time frame: 24 hours
changes of characteristics or amount of drainage
Time frame: 24 hours
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 Dec 2023.
- 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?
An observational study of Renal Replacement Therapy, run by Seoul National University Hospital at 1 site in South Korea.
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 5 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 Dec 2023. 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 South Korea. 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?
clotting time (CT) in EXTEM in rotational thromboelastometry (ROTEM) (time frame: before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy). 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 Dec 2023.