Impact of Dialysis Modality on Coagulation and Platelet Function

Renal Replacement Therapy Clinical Trial

Official title:

Impact of Dialysis Modality on Coagulation and Platelet Function in Critically Ill Patients: Intermittent Hemodialysis vs. Continuous Renal Replacement Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04512131
• Other study ID #: Dialysis mode_coagulation
• Status: Completed
• Start date: August 4, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: December 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 30, 2023
• Est. primary completion date: February 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Renal Replacement Therapy

Intervention

Procedure:
• dialysis mode
intermittent hemodialysis or continuous renal replacement therapy

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul	Jongno-gu

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	complication related to bleeding	gastrointestinal bleeding-hematochezia/melena, intra-abdominal bleeding, airway bleeding	24 hours
Primary	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
Secondary	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
Secondary	clot formation time (CFT) in EXTEM	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
Secondary	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
Secondary	a-angle in EXTEM	the difference of a-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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	the amount of blood transfusion	the amount of blood transfusion for 24 hours after taking second blood sample	24 hours
Secondary	hemodynamic changes	changes of mean arterial pressure > 20 %, increased vasopressor/inotropics	24 hours
Secondary	changes of characteristics or amount of drainage	changes of characteristics or amount of drainage	24 hours