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

Official title

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.

Overview

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.

Interventions

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

Primary outcome measures

• Randomized controlled study feasibility [Time frame: 48 hours after the inclusion]

Secondary outcome measures (9)

• Description of the "standard practice" group [Time frame: 48 hours after the inclusion]
• Description of deviations from the protocol in the "intervention" group" [Time frame: 48 hours after the inclusion]
• Venous congestion prevalence [Time frame: Day 1]
• Haemodynamic instability occurrence [Time frame: Between inclusion and Hour 48 (H48)]
• Severe metabolic disturbance occurrence [Time frame: Day 2]
• Persistent acute Kidney Injury occurrence [Time frame: 48 hours after the inclusion]
• Use of Renal Replacement Therapy (RRT) occurrence [Time frame: Day 30 (D30)]
• Renal adverse events [Time frame: Day 30 (D30)]
• Acute kidney disease occurrence [Time frame: Day 30 (D30)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

France · 2 centers

• Hôpital Louis Pradel, Groupement Hospitalier Est, Hospices Civils de Lyon — Bron
• Hopital cardiologique Louis Pradel — Bron

Identifiers

NCT: NCT06251713 · 69HCL23_0891

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗