Impact of Dialysis Modality on Coagulation and Platelet Function in Critically Ill Patients: Intermittent Hemodialysis vs. Continuous Renal Replacement Therapy
| Registry | NCT04512131 |
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| Status | Completed |
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| Study type | Observational |
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| Enrollment | 60 (Actual) |
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| Sponsor | Seoul National University Hospital (Other) |
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| Conditions | Renal Replacement Therapy |
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| Interventions | dialysis mode (Procedure) |
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| Dates | start 2020-08-04, primary completion 2023-02-27, completion 2023-06-30, first posted 2020-08-13, last updated 2023-12-28 |
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| Locations | 1 site in South Korea |
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-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
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+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.
+Arms and interventions
| Arm | Type | Interventions | Description |
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| Intermittent hemodialysis | | Procedure: dialysis mode | 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 |
| continuous renal replacement therapy | | Procedure: dialysis mode | 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 |
- dialysis mode (Procedure): intermittent hemodialysis or continuous renal replacement therapy
+Outcome measures
Primary outcomes
- clotting time (CT) in EXTEM in rotational thromboelastometry (ROTEM) [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)
Secondary outcomes
- Multiplate® platelet function analysis area under curve unit [before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy]: the difference of platelet function using Multiplate®
- clot formation time (CFT) in EXTEM [before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy]: the difference of CFT in EXTEM using ROTEM (seconds)
- Amplitude 10 minutes after CT (A10) in EXTEM [before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy]: the difference of A10 in EXTEM using ROTEM (mm)
- α-angle in EXTEM [before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy]: the difference of α-angle in EXTEM using ROTEM (º)
- Maximal clot firmness (MCF) in EXTEM [before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy]: the difference of MCF in EXTEM using ROTEM (mm)
- prothrombin time [before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy]: the difference of prothrombin time (seconds)
- activated partial thromboplastin time [before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy]: the difference of activated partial thromboplastin time (seconds)
- Protein C [before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy]: the difference of Protein C
- Protein S [before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy]: the difference of Protein S
- fibrinogen [before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy]: the difference of fibrinogen
- D-dimer [before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy]: the difference of D-dimer
- platelet count [before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy]: the difference of platelet count
- the amount of blood transfusion [24 hours]: the amount of blood transfusion for 24 hours after taking second blood sample
- hemodynamic changes [24 hours]: changes of mean arterial pressure > 20 %, increased vasopressor/inotropics
- changes of characteristics or amount of drainage [24 hours]: changes of characteristics or amount of drainage
Other outcomes
- complication related to bleeding [24 hours]: gastrointestinal bleeding-hematochezia/melena, intra-abdominal bleeding, airway bleeding
+Eligibility
Sex: All, ages: 19 Years to any
Inclusion Criteria:
• Critically ill adult patients in surgical intensive care unit who require renal replacement therapy
Exclusion Criteria:
* 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
+Locations (1)
| Facility | City | Country | Status |
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| Seoul National University Hospital | Seoul, Jongno-gu | South Korea | |
+Study documents