Feasibility of Slow Continuous UltraFiltration For Deresuscitation in Critically Ill Patients

NCT05431491 | Completed DMC

• 1 other identifier: 21021JS-AS
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Fluid Overload

Keywords

Ultrafiltration; Deresuscitation

Outcome Measures

Primary Outcomes (4)

• 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

• Total volume of fluid removed using ultrafiltration

  Assessing the feasibility of fluid removal by ultrafiltration

  5 days per patient

• Circuit lifespan

  The lifespan of each ultrafiltration circuit, to assess the feasibility of using this method as a therapeutic option

  5 days per patient

Secondary Outcomes (7)

• Number of patients developing citrate accumulation

  5 days

• Number of patients developing metabolic alkalosis

  5 days

• Number of patients developing metabolic acidosis

  5 days

• Number of patients with a significant change in sodium

  5 days per patient

• Number of patients developing new onset hyponatraemia

  5 days per patient

Study Arms (1)

Ultrafiltration cohort

EXPERIMENTAL

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

Interventions

Ultrafiltration DEVICE

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

Ultrafiltration cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Belfast Health and Social Care Trust: lead

Study Sites (1)

Belfast City Hospital

Belfast, Down, BT97AB, United Kingdom

Location

MeSH Terms

Conditions

Edema

Interventions

Ultrafiltration

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Extracorporeal Circulation; Surgical Procedures, Operative; Filtration; Chemistry Techniques, Analytical; Investigative Techniques; Physical Phenomena; Chemical Phenomena

Study Officials

• Jon Silversides, PhD

  BHSCT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2022
• First Posted: June 24, 2022
• Study Start: August 12, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 2, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)