RecruitingPhase 3Phase 4ACTRN12612000765820

Filter Life In Renal Replacement Therapy

In critically ill patients with acute kidney injury does continuous renal replacement therapy (CRRT) using a machine controlled citrate protocol compared to a regional heparin protcocol improve safety and extend filter life.


Sponsor

Dr. Matthew Brain

Enrollment

200 participants

Start Date

Mar 28, 2012

Study Type

Interventional

Conditions

Summary

Dialysis is the process of removing fluid and waste products from the blood of patients who have kidney failure. Most people may be familiar with conventional hemodialysis in specialized kidney wards, for patients who have kidney disease and are otherwise well. It is usually performed for around 4 hours, 3 days per week, however these short periods of high intensity dialysis are often not tolerated by the very sick who are better managed with less intense but continuous dialysis. This continuous type of dialysis is called Continuous Renal Replacement Therapy (CRRT) and it is continued in patients in ICU who have kidney failure, until the patient’s kidneys start to work again or they are well enough to move to intermittent dialysis in a kidney ward. During dialysis, blood from the patient is continuously circulated through a filter in the kidney machine, and waste products are removed. There is always the possibility that the blood may clot as it passes through the filter. Patient stability and carefully controlled fluid removal can be compromised if the kidney machine fails too frequently. The most common reason for failure is blood clotting inside the filter – the more this occurs, the less the patient actually receives treatment, and as each filter costs roughly $400 the treatment becomes increasingly expensive. If blood clotting is prevented inside the filter it can last longer - between 24 and 72 hours. Common methods to stop blood clotting (known as anti-coagulation) include adding heparin or citrate to the circuit in the dialysis machine. The primary aim of this study is to compare the filter life using two methods of anticoagulation in CRRT in the Alfred Intensive Care Unit. The first method involves the use of a blood thinner called heparin. Sometimes when higher doses of heparin are required, another drug called protamine that reverses the blood thinning effect is added to the blood in kidney machine circuit. Adding heparin with or without protamine is the method that is currently most used at the Alfred for CRRT. The second method involves the use of citrate fluid in the kidney machine. The citrate binds with calcium and has an anticoagulant effect. Previously, this method proved more labor intensive for the nurses as additional pumps were needed. It tended to be used in special situations e.g. in patients who were allergic to heparin and/or could not receive blood thinners due to a high risk of bleeding. However, recent improvements in the technology of kidney machines have allowed this method to be used much more simply and efficiently. This study has been designed by our doctors at the Alfred Intensive Care Unit to find out if using citrate in the kidney machine is a better and safer way of using CRRT than using heparin in the kidney machine.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study compares two methods of preventing blood clots in the kidney machine filter during intensive care dialysis (called CRRT). One method uses heparin (a blood thinner), and the other uses citrate (a chemical that works differently). If filters last longer, patients receive better treatment and costs are lower. This study is being done in an ICU at The Alfred Hospital. You may be eligible if: - You are 18 years or older - You are in the ICU and need continuous dialysis due to kidney failure - Your kidneys have stopped working due to an acute illness (e.g., oliguria, high potassium, very high creatinine) You may NOT be eligible if: - You weigh less than 30 kg - You need blood thinners (therapeutic dose) for another medical reason - You have previously had a serious reaction to heparin (HIT) - You are allergic to heparin, protamine, or citrate - You are pregnant or breastfeeding - You were already on dialysis before this ICU admission Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

The Gambro Prismaflex CRRT SW 6 supports control of citrate delivery in pre-blood-pump fluid and an algorithm to estimate calcium lost during citrate therapy and utilises this to control the rate of c

The Gambro Prismaflex CRRT SW 6 supports control of citrate delivery in pre-blood-pump fluid and an algorithm to estimate calcium lost during citrate therapy and utilises this to control the rate of calcium replacement via a syringe driver. Our protocol determines the initial citrate and calicum replacement rates after which the performance of the system is monitored by regularly testing patient and circuit calicum levels with adjustments as required. The control arm is the standard regional heparin protocol (including criteria to escalate to protamine) that is in established use in the Alfred Intensive Care Unit. CRRT will continue until the patient no longer requires it (recovery or move to permanent intermittent dialysis). This may result in periods off CRRT to assess adequacy of recovery. They will remain in the treatment arm unless a contra-indication develops or the treating physician withdraws.


Locations(1)

Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12612000765820


Related Trials