What side effects are associated with this type of intervention?

The Low Splanchnic Blood Volume Restrictive Fluid Management Strategy, which includes phlebotomy and hemodynamic goal-directed restrictive fluid management, can have side effects such as infection, bleeding, and transfusion reactions from phlebotomy. Additionally, restrictive fluid management may lead to hypovolemia, electrolyte imbalances, and renal dysfunction if not carefully monitored. These treatments necessitate precise management to minimize risks and ensure patient safety.

What other types of research exist?

Promising novel alternatives for liver transplant patients in 2024 include: 1) Enhanced Recovery After Surgery (ERAS) protocols, which optimize perioperative care to improve outcomes; 2) Use of normothermic machine perfusion (NMP) to preserve donor liver function and reduce ischemia-reperfusion injury; 3) Implementation of advanced hemodynamic monitoring systems to tailor fluid management more precisely; 4) Pharmacological agents like vasopressin analogs to maintain hemodynamic stability without excessive fluid administration.

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Procedure

Restrictive Fluid Management for Liver Transplant Patients (REFIL Trial)

Q: What prior FDA approvals exist?

FDA approvals for liver transplant treatments have primarily focused on immunosuppressive therapies to prevent organ rejection, such as tacrolimus, cyclosporine, and mycophenolate mofetil. While specific FDA approvals for fluid management strategies like the Low Splanchnic Blood Volume Restrictive Fluid Management Strategy are not detailed, the approach aligns with broader perioperative care practices aimed at optimizing hemodynamics and fluid balance. These practices are critical in managing patients during liver transplantation to ensure stability and improve outcomes.

N/A

Recruiting

Led By Francois-Martin Carrier, MD

Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization up to hospital discharge (ascertained up to end of follow-up at 1 year)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a method of carefully managing fluids during liver transplant surgery for patients with severe liver disease. The goal is to see if this approach can reduce complications and improve recovery by keeping blood volume in the abdominal organs low. This method has been shown to reduce complications following various major surgeries.

Who is the study for?

The REFIL trial is for adults over 18 years old who need a liver transplant due to end-stage liver disease (ESLD). It's not for those with acute liver failure, cancer without ESLD, retransplantation, amyloid neuropathy, severe kidney failure (GFR < 15), severe anemia (hemoglobin < 80 g/L), or hemodynamic instability.

What is being tested?

This study compares two fluid management strategies during liver transplantation. One group receives a restrictive strategy with phlebotomy and limited fluids; the other gets a liberal strategy aiming to optimize cardiac output. The goal is to see which method leads to better outcomes.

What are the potential side effects?

Potential side effects may include complications from phlebotomy such as bleeding or infection, fluid imbalance issues like dehydration or overload affecting organ function, and possible cardiovascular stress from managing blood flow and volume.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization up to hospital discharge (ascertained up to end of follow-up at 1 year)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization up to hospital discharge (ascertained up to end of follow-up at 1 year)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization up to hospital discharge (ascertained up to end of follow-up at 1 year) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

6-month outcome measurement completeness

Adherence

Hospital outcome measurement completeness

+2 more

Secondary study objectives

7-day AKI (grade 2 or 3)

7-day graft dysfunction

7-day quality of recovery

+12 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Restrictive group: Low splanchnic blood volume Restrictive fluid management strategyExperimental Treatment2 Interventions

The intervention group is targeted at lowering splanchnic blood volume using a phlebotomy and restricting fluid infusion, individualized to the physiological needs of this population and the distinct LT surgical phases. The strategy will first consist of performing a phlebotomy without fluid replacement at the start of surgery.We will combine it with fluid restriction to prevent excessive fluid administration and its effect on splanchnic blood volume and blood loss, combined with the effect of the phlebotomy, as well as to limit fluid overload, as previously reported. Fluid will be administered to compensate blood loss and treat severe hemodynamic instability.The phlebotomy will be transfused back at the beginning of the reperfusion phase where fluid management will be based on a goal-directed therapy (GDT) using either PPV or SV, as in the control group.

Group II: Liberal group: Optimized cardiac output liberal fluid management strategyActive Control1 Intervention

The control group will receive a liberal intraoperative fluid management strategy optimizing cardiac output throughout the surgery. It will consist of administering 250 mL fluid boluses until SV stops to increase by more than 10% or until PPV is below 12%, a dynamic indicator of fluid responsiveness validated in many surgical populations, including ESLD patients undergoing a LT.This strategy is informed by data from recent clinical trials on benefits of GDT in major surgery, data on strategies used in major surgery, liver resection or LT and our survey on current practice.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Phlebotomy

2016

Completed Phase 3

~1200

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The Low Splanchnic Blood Volume Restrictive Fluid Management Strategy for liver transplant patients involves two main components: phlebotomy and hemodynamic goal-directed restrictive fluid management. Phlebotomy, performed before dissection and transfused back after graft reperfusion, helps to manage blood volume and reduce the risk of complications related to fluid overload. Hemodynamic goal-directed restrictive fluid management aims to optimize cardiac output and maintain stable hemodynamics by carefully controlling fluid administration based on real-time monitoring. This approach is crucial for liver transplant patients as it minimizes the risk of fluid overload, which can lead to complications such as pulmonary edema and impaired graft function, thereby improving overall outcomes and recovery.