Clinical trial NCT04512131: Impact of Dialysis Modality on Coagulation and Platelet Function
Official title: Impact of Dialysis Modality on Coagulation and Platelet Function in Critically Ill Patients: Intermittent Hemodialysis vs. Continuous Renal Replacement Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Replacement Therapy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2020-08-13
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: critically ill adult patients in surgical intensive care unit requiring renal replacement therapy

Brief 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: clotting time (CT) in EXTEM in rotational thromboelastometry (ROTEM)
timeFrame: before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy
Secondary outcomes:
measure: Multiplate® platelet function analysis area under curve unit
timeFrame: before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy
measure: clot formation time (CFT) in EXTEM
timeFrame: before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy
measure: Amplitude 10 minutes after CT (A10) in EXTEM
timeFrame: before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy
measure: α-angle in EXTEM
timeFrame: before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy
measure: Maximal clot firmness (MCF) in EXTEM
timeFrame: before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy
measure: prothrombin time
timeFrame: before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy
measure: activated partial thromboplastin time
timeFrame: before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy
measure: Protein C
timeFrame: before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy
measure: Protein S
timeFrame: before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy
measure: fibrinogen
timeFrame: before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy
measure: D-dimer
timeFrame: before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy
measure: platelet count
timeFrame: before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy
measure: the amount of blood transfusion
timeFrame: 24 hours
measure: hemodynamic changes
timeFrame: 24 hours
measure: changes of characteristics or amount of drainage
timeFrame: 24 hours
Other outcomes:
measure: complication related to bleeding
timeFrame: 24 hours
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongno-gu
Study officials:
References: