Fluid-removal Guided by VeXUS Score With Usual Care in Patients With Acute Kidney Injury After Cardiac Surgery (VeXUS)

February 27, 2024 updated by: Hospices Civils de Lyon

Feasibility of a Randomised Trial Comparing a Fluid-removal Guided by VeXUS Score With Usual Care in Patients With Acute Kidney Injury After Cardiac Surgery: a Pilot Randomised Trial.

Acute kidney injury affects more than 30% of patients after cardiac surgery, and is associated with an excess in mortality. There is a clinical continuum between acute kidney injury (transient if <48h, persistent if >48h), the development of acute kidney and chronic renal failure. Each of these entities characterising renal recovery is associated with an increase in long-term morbidity and mortality. Fluid management in patients with acute kidney injury is challenging, as both hypovolaemia and hypervolaemia are detrimental. Venous congestion (reflecting intravascular hypervolaemia), is a well-established haemodynamic factor contributing to acute kidney injury after cardiac surgery. An ultrasound score, based on the venous doppler pattern explored in intra-abdominal organs, has recently been developed and is a better predictor of acute kidney injury than central venous pressure. Whether using the VeXUS score to guide fluid removal in haemodynamically stabilised patients could promote renal recovery after acute kidney injury remains to be investigated.

Before designing a large randomised trial to test such a strategy, its feasibility in a pilot randomised trial is assessed.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Bron, France, 69500
        • Not yet recruiting
        • Hôpital Louis Pradel, Groupement Hospitalier Est, Hospices Civils de Lyon
        • Contact:
      • Bron, France
        • Recruiting
        • Hopital cardiologique Louis Pradel
        • Contact:
          • FELLAHI Jean-Luc, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Intensive care unit admission within 72 hours of cardiac surgery with extracorporeal circulation
  • Acute kidney injury defined by KDIGO criteria
  • Vasoactive inotropic score <45 and capillary refill time <3s
  • Informed written consent

Exclusion Criteria:

  • Hypokalaemia <3.5mmol/L
  • Hyponatremia<125mmol/L
  • Hypernatremia >145mmol/L
  • Metabolic alkalosis with pH >7.50
  • Impossibility to measure capillary refill time
  • Chronic liver disease
  • Cirrhosis with portal hypertension
  • Known thrombus of the inferior vena cava
  • Mechanical circulatory assistance (ECMO or mono left ventricular assistance)
  • Severe pre-operative chronic kidney disease (GFR < 30mL/min/1.73m2)
  • Need for renal replacement therapy anticipated by the attending physician within 24 hours
  • Known hypersensitivity to Furosemide and/or hydrochlorothiazide
  • Severe allergy to wheat
  • Patient already included in another interventional study with an exclusion period still in progress
  • Pregnant, breast-feeding or women of childbearing age without suitable contraception
  • Patients under guardianship, curatorship or safeguard of justice
  • Patients under psychiatric care
  • Patients not affiliated to a social security scheme or beneficiaries of a similar scheme

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VeXUS score guided fluid management

Fluid management:

  • Restrictive intake
  • Diuretic-induced fluid removal aiming for a diuresis of 2-4mL/Kg/h if VeXUS score > 1
  • During 24 to 48 hours

During the first 3 postoperative days, the VeXUS score is estimated daily by ultrasound. If VeXUS score >1, diuretic-induced fluid removal will be administred (target diuresis: 2-4mL/kg/h). The diuretic administration protocol is derived from the CARRESS HF study: bolus followed by a continuous administration of Furosemide with thiazide added based on preoperative diuretic administration status.

To prevent hypokalaemia and dysnatremia, a protocol for potassium supplementation and intravenous administration of chloride serum or hypotonic perfusion is planned.

Fluid removal will be suspended if severe metabolic disturbance (pH>7.55 with HCO3->40mmol/L or serum K+ <3 mmol/L or serum Na>150 mmol/L) or haemodynamic instability (hypoperfusion) with fluid responsiveness occurs. Regardless of the VeXUS score, diuretics will be introduced in case of pulmonary oedema.

Haemodynamic status will be every 12 hours to detect side effects attributable to diuretic-induced fluid removal.

Other: Usual care

Fluid management:

  • Usual care
  • at the discretion of the attending physician
Fluid management will be at the discretion of attending physician, who will be blinded to the patient's VeXUS score status.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Randomized controlled study feasibility
Time Frame: 48 hours after the inclusion
Percentage of patients recruited without deviations from the protocol (number of patients included per month) at the end of the recruitment and follow-up period, i.e. the number of patients who received the full initial treatment (48 hours) in accordance with the interventional protocol out of the number of patients eligible for the study.
48 hours after the inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of the "standard practice" group
Time Frame: 48 hours after the inclusion
The standard practice groupe will be describe. The description will be based on the number of patients concerned by the administration of diuretics, molecule and dosage used, reason for the administration of diuretics, cumulative fluid balance.
48 hours after the inclusion
Description of deviations from the protocol in the "intervention" group"
Time Frame: 48 hours after the inclusion
To evaluation de faisability of the trial, the description of the deviations occurring in the intervention group will be based on the number of patients concerned, nature of the deviation from the protocol, cumulative fluid balance.
48 hours after the inclusion
Venous congestion prevalence
Time Frame: Day 1
Proportion of patients with VeXUS score >1 at the inclusion
Day 1
Haemodynamic instability occurrence
Time Frame: Between inclusion and Hour 48 (H48)
Occurrence of Mottling score>1 or capillary refill time>3s
Between inclusion and Hour 48 (H48)
Severe metabolic disturbance occurrence
Time Frame: Day 2
Occurrence of serum potassium <3mmol/L, serum sodium >150 mmol/L, arterial pH>7.55 with HCO3->40mmol/L
Day 2
Persistent acute Kidney Injury occurrence
Time Frame: 48 hours after the inclusion
Description and comparison of the persistent acute Kidney Injury occurrence in the 2 groups
48 hours after the inclusion
Use of Renal Replacement Therapy (RRT) occurrence
Time Frame: Day 30 (D30)
Description and comparison of the RRT requirement in the 2 groups
Day 30 (D30)
Renal adverse events
Time Frame: Day 30 (D30)
Description and comparison of the 2 groups for the composite criteria : death or Renal Replacement therapy dependence or creatinine > 200% baseline creatinine.
Day 30 (D30)
Acute kidney disease occurrence
Time Frame: Day 30 (D30)
Description and comparison of the 2 groups for the composite criteria : albuminuria or GFR <60mL/min/1.73m or decrease of more than 35% in GFR.
Day 30 (D30)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

January 15, 2024

First Submitted That Met QC Criteria

February 1, 2024

First Posted (Actual)

February 9, 2024

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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