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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VeXUS score guided fluid management | Experimental | Fluid management:
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| Usual care | Other | Fluid management:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VeXUS score guided fluid management strategy | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean-Luc Fellahi, MD | Contact | +334 72 31 89 44 | jean-luc.fellahi@chu-lyon.fr | |
| RUSTE Martin, MD | Contact | +334 72 11 89 56 | martin.ruste@chu-lyon.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Louis Pradel, Groupement Hospitalier Est, Hospices Civils de Lyon | Not yet recruiting | Bron | Bron | 69500 | France |
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| Usual care | Other | Fluid management will be at the discretion of attending physician, who will be blinded to the patient's VeXUS score status. |
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| 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 |
| Venous congestion prevalence | Proportion of patients with VeXUS score >1 at the inclusion | Day 1 |
| Haemodynamic instability occurrence | Occurrence of Mottling score>1 or capillary refill time>3s | Between inclusion and Hour 48 (H48) |
| 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 |
| Persistent acute Kidney Injury occurrence | 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 | Description and comparison of the RRT requirement in the 2 groups | Day 30 (D30) |
| 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) |
| 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) |
| Hopital cardiologique Louis Pradel | Recruiting | Bron | France |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D006940 | Hyperemia |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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