Clinical trial NCT05431491: Feasibility of Slow Continuous UltraFiltration For Deresuscitation in Critically Ill Patients
Official title: Feasibility of Slow Continuous Ultrafiltration With Regional Anticoagulation for Deresuscitation in Critically Ill Patients Though Standard Central or Peripheral Venous Access.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fluid Overload
Keywords: Ultrafiltration
Deresuscitation
Lead sponsor: Belfast Health and Social Care Trust
Sponsor class: OTHER
First posted: 2022-06-24
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with daily fluid balance within 500 mL of prescribed target
timeFrame: 5 days per patient
measure: Number of patients with filter or circuit thrombosis requiring discontinuation of therapy
timeFrame: 5 days per patient
measure: Total volume of fluid removed using ultrafiltration
timeFrame: 5 days per patient
measure: Circuit lifespan
timeFrame: 5 days per patient
Secondary outcomes:
measure: Number of patients developing citrate accumulation
timeFrame: 5 days
measure: Number of patients developing metabolic alkalosis
timeFrame: 5 days
measure: Number of patients developing metabolic acidosis
timeFrame: 5 days
measure: Number of patients with a significant change in sodium
timeFrame: 5 days per patient
measure: Number of patients developing new onset hyponatraemia
timeFrame: 5 days per patient
measure: Number of patients developing new onset hypernatraemia
timeFrame: 5 days per patient
measure: Number of patients developing new onset hypokalaemia
timeFrame: 5 days per patient
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Belfast City Hospital
state: Down
Study officials:
affiliation: BHSCT
name: Jon Silversides, PhD
role: PRINCIPAL_INVESTIGATOR
References: