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

ConditionsAcute Kidney InjuryCardiac SurgeryVenous CongestionHemodynamic Stability
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorHospices Civils de Lyon

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Hypokalaemia <3.5mmol/L

Hyponatremia<125mmol/L

Hypernatremia >145mmol/L

Metabolic alkalosis with pH >7.50

Trial design

Design model

Parallel

Treatments tested in this trial

  • VeXUS score guided fluid management strategy

    Other intervention

    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.

  • Usual care

    Other intervention

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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: VeXUS score guided fluid managementExperimental treatment 1 intervention
Group B: Usual careOther 1 intervention

Trial outcomes

Primary outcomes

1

Randomized controlled study feasibility

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.

Time frame
48 hours after the inclusion

Secondary outcomes

1

Description of the "standard practice" group

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.

Time frame
48 hours after the inclusion
2

Description of deviations from the protocol in the "intervention" group"

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.

Time frame
48 hours after the inclusion
3

Venous congestion prevalence

Proportion of patients with VeXUS score \>1 at the inclusion

Time frame
Day 1
4

Haemodynamic instability occurrence

Occurrence of Mottling score\>1 or capillary refill time\>3s

Time frame
Between inclusion and Hour 48 (H48)

Other outcomes

Sponsors and contacts

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Hospices Civils de Lyon

Lead sponsor

Source ClinicalTrials.gov
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