Feasibility of Slow Continuous UltraFiltration For Deresuscitation in Critically Ill Patients

Fluid Overload Clinical Trial

— SCUFFD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05431491
• Other study ID #: 21021JS-AS
• Status: Recruiting
• Phase: N/A
• Start date: August 12, 2022
• Est. completion date: March 1, 2024

Study information

• Verified date: September 2023
• Source: Belfast Health and Social Care Trust
• Contact: Neil Cody, MBChB
• Phone: 00447525261112
• Email: neil.cody[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: March 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Fluid Overload

Intervention

Device:
• Ultrafiltration
Ultrafiltration through much smaller intravenous cannula than what has previously been used.

Locations

Country	Name	City	State
United Kingdom	Belfast City Hospital	Belfast	Down

Sponsors (1)

Lead Sponsor	Collaborator
Belfast Health and Social Care Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Number of patients developing citrate accumulation	Defined as systemic total:ionised calcium ratio greater than 2.5	5 days
Secondary	Number of patients developing metabolic alkalosis	Defined as new onset Bicarbonate>30 and pH >7.5	5 days
Secondary	Number of patients developing metabolic acidosis	Defined as new onset Bicarbonate<18 and pH<7.30	5 days
Secondary	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
Secondary	Number of patients developing new onset hyponatraemia	Defined as new onset sodium <130mmol/l	5 days per patient
Secondary	Number of patients developing new onset hypernatraemia	Defined as new onset sodium >150mmol/l	5 days per patient
Secondary	Number of patients developing new onset hypokalaemia	Defined as new onset potassium < 3mmol/l	5 days per patient