Feasibility of Slow Continuous UltraFiltration For Deresuscitation in Critically Ill Patients

NCT ID: NCT05431491

Last Updated: 2025-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-12
• Study Completion Date: 2024-12-01

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.

Conditions

Fluid Overload

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ultrafiltration cohort

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.

Group Type: EXPERIMENTAL

Ultrafiltration

Intervention Type: DEVICE

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

Interventions

Ultrafiltration

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Belfast Health and Social Care Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jon Silversides, PhD

Role: PRINCIPAL_INVESTIGATOR

BHSCT

Locations

Belfast City Hospital

Belfast, Down, United Kingdom

Countries

United Kingdom

Other Identifiers

21021JS-AS

Identifier Type: -

Identifier Source: org_study_id