An observational study in Renal Replacement Therapy, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2023-12-28.
Sponsored by Seoul National University Hospital · Observational
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.
Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
critically ill adult patients in surgical intensive care unit requiring renal replacement therapy
Exclusion Criteria:
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
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
Procedure: dialysis mode
intermittent hemodialysis or continuous renal replacement therapy
clotting time (CT) in EXTEM in rotational thromboelastometry (ROTEM)
the difference of changes in CT in EXTEM of ROTEM (seconds)
Time frame: before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy
Multiplate® platelet function analysis area under curve unit
the difference of platelet function using Multiplate®
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
the difference of CFT in EXTEM using ROTEM (seconds)
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
the difference of A10 in EXTEM using ROTEM (mm)
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
the difference of α-angle in EXTEM using ROTEM (º)
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
the difference of MCF in EXTEM using ROTEM (mm)
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
the difference of prothrombin time (seconds)
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
the difference of activated partial thromboplastin time (seconds)
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
the difference of 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
the difference of 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
the difference of 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
the difference of 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
the difference of 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
the amount of blood transfusion for 24 hours after taking second blood sample
Time frame: 24 hours
hemodynamic changes
changes of mean arterial pressure \> 20 %, increased vasopressor/inotropics
Time frame: 24 hours
changes of characteristics or amount of drainage
changes of characteristics or amount of drainage
Time frame: 24 hours
complication related to bleeding
gastrointestinal bleeding-hematochezia/melena, intra-abdominal bleeding, airway bleeding
Time frame: 24 hours
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Seoul National University Hospital