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Fondaparinux as an Anticoagulant in Haemofiltration in Patients With Acute Kidney Failure.

2014-08-27 03:47:32 | BioPortfolio

Summary

The purpose of this project is to assess the safety and effectiveness of fondaparinux, a new drug to prevent blood clotting in the continuous dialysis machine used in intensive care patients who have kidney failure.

Description

The study hypothesis is that when used as an anticoagulant in haemofiltration, fondaparinux prolongs the filter life when compared to enoxaparin.

Fondaparinux is the first compound of a new class of synthetic oligosaccharides with antithrombotic effects. It represents the active portion of the natural heparin molecule.

The null hypothesis is that there is no difference in filter life when using fondaparinux or enoxaparin as anticoagulation for haemofiltration.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Patients Requiring Haemofiltration for Acute Renal Failure.

Intervention

Fondaparinux Sodium

Location

The Royal Melbourne Hospital Intensive Care Unit Grattan Street
Parkville
Victoria
Australia
3050

Status

Recruiting

Source

Melbourne Health

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:47:32-0400

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Medical and Biotech [MESH] Definitions

A severe irreversible decline in the ability of kidneys to remove wastes, concentrate URINE, and maintain ELECTROLYTE BALANCE; BLOOD PRESSURE; and CALCIUM metabolism. Renal failure, either acute (KIDNEY FAILURE, ACUTE) or chronic (KIDNEY FAILURE, CHRONIC), requires HEMODIALYSIS.

Functional KIDNEY FAILURE in patients with liver disease, usually LIVER CIRRHOSIS or portal hypertension (HYPERTENSION, PORTAL), and in the absence of intrinsic renal disease or kidney abnormality. It is characterized by intense renal vasculature constriction, reduced renal blood flow, OLIGURIA, and sodium retention.

Conditions in which the KIDNEYS perform below the normal level in the ability to remove wastes, concentrate URINE, and maintain ELECTROLYTE BALANCE; BLOOD PRESSURE; and CALCIUM metabolism. Renal insufficiency can be classified by the degree of kidney damage (as measured by the level of PROTEINURIA) and reduction in GLOMERULAR FILTRATION RATE. The most severe form is KIDNEY FAILURE. Renal function may deteriorate slowly (RENAL INSUFFICIENCY, CHRONIC) or precipitously (RENAL INSUFFICIENCY, ACUTE).

A severe stage of acute renal insufficiency, characterized by the sudden decrease in GLOMERULAR FILTRATION RATE to less than 15 ml per min, sometime to less than 1 to 2 ml per min. It is usually associated with OLIGURIA; EDEMA; and increase in BLOOD UREA NITROGEN and serum CREATININE concentrations.

Conditions in which the function of KIDNEYS deteriorates suddenly in a matter of days or even hours. It is characterized by the sudden drop in GLOMERULAR FILTRATION RATE; (GMR). The most severe stage is when the GFR drops below 15 ml per min (ACUTE KIDNEY FAILURE).

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