Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00286273
Status:
COMPLETED
Last Update Posted:
2009-08-26
First Post:
2006-02-01
Brief Title:
Safety and Efficacy of the Use of Regional Anticoagulation With Citrate in Continuous Venovenous Hemofiltration
Sponsor:
Onze Lieve Vrouwe Gasthuis
Organization:
Onze Lieve Vrouwe Gasthuis
Study Overview
Official Title:
Safety and Efficacy of the Use of Regional Anticoagulation With Citrate in Continuous Venovenous Hemofiltration a Randomized Controlled Trial Comparing Anticoagulation With Citrate to the Low Molecular Weight Heparin Nadroparin
Status:
COMPLETED
Status Verified Date:
2009-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Severely ill patients admitted to the intensive care unit may develop an acute failure of kidney function To bridge the period to recovery renal function is temporarily replaced by continuous venovenous hemofiltration CVVH To prevent clotting of the hemofiltration circuit heparin is generally used providing anticoagulation in the circuit and the patient As a result bleeding complications may occur necessitating the transfusion of blood Anticoagulation of the circuit can also be obtained with the use of tri-sodium citrate which provides anticoagulation of the circuit without affecting coagulation in the patient and thus without increasing hisher risk of bleeding The use of citrate may however cause metabolic complications
Primary aim of the present study is to show in a larger group of intensive care patients whether the use of regional anticoagulation with citrate is safe compared to systemic anticoagulation with the low molecular weight heparin nadroparin
Primary aim of the present study is to show in a larger group of intensive care patients whether the use of regional anticoagulation with citrate is safe compared to systemic anticoagulation with the low molecular weight heparin nadroparin
Detailed Description:
Severely ill patients admitted to the intensive care unit may develop an acute failure of kidney function Renal function generally recovers if the acute illness improves To bridge this period renal function is temporarily replaced by continuous hemofiltration so called continuous venovenous hemofiltration CVVH To remove toxic substances and fluids the patients blood flows through a circuit containing a filter Flow in the filter is regulated by the CVVH-device
Normally blood starts to clot as soon as it leaves the body To prevent clotting of the blood in the filter the blood has to be anticoagulated For this purpose heparins are generally used Heparins make the blood less likely to clot Drawback of the use of heparins is that they not only prevent clotting of blood in the circuit and the filter but also in the patient Heparins thereby increase the risk of bleeding Intensive care patients are at higher risk of bleeding due to a recent operation or trauma ulcers in the mouth or the stomach or abnormalities in their blood to the acute illness Due to the continuous application of CVVH for days anticoagulation is administered without interruption over prolonged periods of time Studies report bleeding complications in 5 to 50 of the patients As a result of bleeding patients need blood transfusion and sometimes surgery Control of bleeding is sometimes extremely difficult
An alternative to heparin is citrate which allows regional anticoagulation of the circuit and the filter without an effect increasing the risk of bleeding for the patient Anticoagulation with citrate is more complex nurses need to follow a strict protocol Several small studies have shown that regional anticoagulation with citrate is associated with less bleeding and a longer filter survival The use if citrate is however associated with a greater risk of metabolic complications if the protocol is not strictly followed Primary aim of the present study is to show in a larger group of intensive care patients whether the use of regional anticoagulation with citrate is safe compared to systemic anticoagulation with the low molecular weight heparin nadroparin
Normally blood starts to clot as soon as it leaves the body To prevent clotting of the blood in the filter the blood has to be anticoagulated For this purpose heparins are generally used Heparins make the blood less likely to clot Drawback of the use of heparins is that they not only prevent clotting of blood in the circuit and the filter but also in the patient Heparins thereby increase the risk of bleeding Intensive care patients are at higher risk of bleeding due to a recent operation or trauma ulcers in the mouth or the stomach or abnormalities in their blood to the acute illness Due to the continuous application of CVVH for days anticoagulation is administered without interruption over prolonged periods of time Studies report bleeding complications in 5 to 50 of the patients As a result of bleeding patients need blood transfusion and sometimes surgery Control of bleeding is sometimes extremely difficult
An alternative to heparin is citrate which allows regional anticoagulation of the circuit and the filter without an effect increasing the risk of bleeding for the patient Anticoagulation with citrate is more complex nurses need to follow a strict protocol Several small studies have shown that regional anticoagulation with citrate is associated with less bleeding and a longer filter survival The use if citrate is however associated with a greater risk of metabolic complications if the protocol is not strictly followed Primary aim of the present study is to show in a larger group of intensive care patients whether the use of regional anticoagulation with citrate is safe compared to systemic anticoagulation with the low molecular weight heparin nadroparin
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None