Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dialysis mode | Procedure | intermittent hemodialysis or continuous renal replacement therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| clotting time (CT) in EXTEM in rotational thromboelastometry (ROTEM) | the difference of changes in CT in EXTEM of ROTEM (seconds) | before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Multiplate® platelet function analysis area under curve unit | the difference of platelet function using Multiplate® | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| complication related to bleeding | gastrointestinal bleeding-hematochezia/melena, intra-abdominal bleeding, airway bleeding | 24 hours |
Inclusion Criteria:
• Critically ill adult patients in surgical intensive care unit who require renal replacement therapy
Exclusion Criteria:
Not provided
Not provided
Not provided
critically ill adult patients in surgical intensive care unit requiring renal replacement therapy
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | Jongno-gu | 03080 | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 20, 2023 | Dec 20, 2023 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
the difference of CFT in EXTEM using ROTEM (seconds) |
| 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) | 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) | 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) | 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) | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 24 hours |
| hemodynamic changes | changes of mean arterial pressure > 20 %, increased vasopressor/inotropics | 24 hours |
| changes of characteristics or amount of drainage | changes of characteristics or amount of drainage | 24 hours |