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

Acute Kidney Injury Clinical Trial

— VeXUS  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06251713
• Other study ID #: 69HCL23_0891
• Status: Recruiting
• Phase: N/A
• Start date: February 2024
• Est. completion date: March 2025

Study information

• Verified date: February 2024
• Source: Hospices Civils de Lyon
• Contact: Jean-Luc Fellahi, MD
• Phone: +334 72 31 89 44
• Email: jean-luc.fellahi[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Cardiac Surgery
• Hemodynamic Stability
• Hyperemia
• Venous Congestion
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
France	Hopital cardiologique Louis Pradel	Bron
France	Hôpital Louis Pradel, Groupement Hospitalier Est, Hospices Civils de Lyon	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	48 hours after the inclusion
Secondary	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.	48 hours after the inclusion
Secondary	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.	48 hours after the inclusion
Secondary	Venous congestion prevalence	Proportion of patients with VeXUS score >1 at the inclusion	Day 1
Secondary	Haemodynamic instability occurrence	Occurrence of Mottling score>1 or capillary refill time>3s	Between inclusion and Hour 48 (H48)
Secondary	Severe metabolic disturbance occurrence	Occurrence of serum potassium <3mmol/L, serum sodium >150 mmol/L, arterial pH>7.55 with HCO3->40mmol/L	Day 2
Secondary	Persistent acute Kidney Injury occurrence	Description and comparison of the persistent acute Kidney Injury occurrence in the 2 groups	48 hours after the inclusion
Secondary	Use of Renal Replacement Therapy (RRT) occurrence	Description and comparison of the RRT requirement in the 2 groups	Day 30 (D30)
Secondary	Renal adverse events	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)
Secondary	Acute kidney disease occurrence	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)