Acute Kidney Injury, Cardiac Surgery, Hemodynamic Stability, Venous Congestion
Conditions
Keywords
Acute kidney injury, Cardiac surgery, Venous Congestion, VeXUS score, diuretic, fluid removal
Brief 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.
Interventions
OTHERVeXUS 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.
OTHERUsual care
Fluid management will be at the discretion of attending physician, who will be blinded to the patient's VeXUS score status.
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Randomized controlled study feasibility | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Description of the "standard practice" group | 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. |
| Description of deviations from the protocol in the "intervention" group" | 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. |
| Venous congestion prevalence | Day 1 | Proportion of patients with VeXUS score \>1 at the inclusion |
| Haemodynamic instability occurrence | Between inclusion and Hour 48 (H48) | Occurrence of Mottling score\>1 or capillary refill time\>3s |
| Severe metabolic disturbance occurrence | Day 2 | Occurrence of serum potassium \<3mmol/L, serum sodium \>150 mmol/L, arterial pH\>7.55 with HCO3-\>40mmol/L |
| Persistent acute Kidney Injury occurrence | 48 hours after the inclusion | Description and comparison of the persistent acute Kidney Injury occurrence in the 2 groups |
| Use of Renal Replacement Therapy (RRT) occurrence | Day 30 (D30) | Description and comparison of the RRT requirement in the 2 groups |
| Renal adverse events | 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. |
| Acute kidney disease occurrence | 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. |
Countries
France
Contacts
CONTACTJean-Luc Fellahi, MD
CONTACTRUSTE Martin, MD
Outcome results
None listed