Feasibility of Slow Continuous UltraFiltration For Deresuscitation in Critically Ill Patients

Study Overview
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Brief Summary
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To determine the feasibility and safety of deresuscitation using slow continuous ultrafiltration with regional citrate anticoagulation and peripheral or standard central venous access.

Detailed Description
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Fluid deresuscitation has been shown to have favourable outcomes in the management of the critically ill patient. Whilst diuretic medications have previously been the mainstay of achieving this deresuscitation, the metabolic and biochemical complications associated with their use can limit their application. Mechanical ultrafiltration is another means of achieving fluid deresuscitation and has theoretical benefits over the use of intravenous diuretics. It allows a more titratable process, without the potential metabolic complications. The use of ultrafiltration has been limited by the requirement of wide bore central venous access. The SCUFFD study is a means of assessing whether ultrafiltration with regional anticoagulation can be achieved through standard central or peripheral venous access.

Official Title
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Feasibility of Slow Continuous Ultrafiltration With Regional Anticoagulation for Deresuscitation in Critically Ill Patients Though Standard Central or Peripheral Venous Access.

Conditions
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Fluid Overload

Intervention / Treatment
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* Device: Ultrafiltration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (>18 years) Evidence of fluid overload (greater than trace amount of peripheral oedema in >1 site, pulmonary oedema on chest radiograph, or positive fluid balance equivalent to >5% body weight) Clinician intention to target a negative fluid balance Expected to remain in a critical care setting beyond the next calendar day Exclusion Criteria: Anticipated unavailability of suitable vascular access Lack of commitment to full support Receiving or imminently planned to receive renal replacement therapy Hyponatraemia (Sodium <130mmol/L) Hypernatraemia (Sodium >150mmol/L) Significant metabolic alkalosis (Bicarbonate>30 and pH>7.5) Significant metabolic acidosis (HCO3- <18 mmol/l and pH < 7.30) Uncorrected hypokalaemia (Potassium <3.0mmol/L) Liver failure (Child-Pugh Grade B or above) Shock (any of: lactate >3mmol/L, extensive skin mottling, central capillary refill time>3 seconds, more than 1 vasoactive agent in use, noradrenaline dose >0.2 mcg/kg/min, use of dobutamine, adrenaline, milrinone, enoximone or levosimendan) Receiving any systemic anticoagulation other than for routine venous thromboembolism prophylaxis, or dual antiplatelet therapy Prisoner Known pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrafiltration cohort<br>These patients will be recruited into the study to assess the feasibility of slow continuous ultrafiltration through either a standard central venous catheter, or peripheral intravenous cannula. | Device: Ultrafiltration<br>* Ultrafiltration through much smaller intravenous cannula than what has previously been used.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with daily fluid balance within 500 mL of prescribed target | Assessing the feasibility of managing to achieve the target fluid balance | 5 days per patient | 
| Number of patients with filter or circuit thrombosis requiring discontinuation of therapy | Ensuring that the process of haemofiltration does not result in unacceptable levels of thrombotic events | 5 days per patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients developing citrate accumulation | Defined as systemic total:ionised calcium ratio greater than 2.5 | 5 days | 
| Number of patients developing metabolic alkalosis | Defined as new onset Bicarbonate>30 and pH >7.5 | 5 days | 
| Number of patients developing metabolic acidosis | Defined as new onset Bicarbonate<18 and pH<7.30 | 5 days | 
| Number of patients with a significant change in sodium | Defined as new onset change in sodium >8mmol/l in 24 hours or less | 5 days per patient | 
| Number of patients developing new onset hyponatraemia | Defined as new onset sodium <130mmol/l | 5 days per patient | 
| Number of patients developing new onset hypernatraemia | Defined as new onset sodium >150mmol/l | 5 days per patient | 
| Number of patients developing new onset hypokalaemia | Defined as new onset potassium < 3mmol/l | 5 days per patient | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ultrafiltration, Deresuscitation