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
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Kidney Injury
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Randomized controlled study feasibility
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
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)
Outcomes
Primary Outcomes
Randomized controlled study feasibility
Time Frame: 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 Outcomes
- Venous congestion prevalence(Day 1)
- Persistent acute Kidney Injury occurrence(48 hours after the inclusion)
- Renal adverse events(Day 30 (D30))
- Description of the "standard practice" group(48 hours after the inclusion)
- Use of Renal Replacement Therapy (RRT) occurrence(Day 30 (D30))
- Description of deviations from the protocol in the "intervention" group"(48 hours after the inclusion)
- Acute kidney disease occurrence(Day 30 (D30))
- Haemodynamic instability occurrence(Between inclusion and Hour 48 (H48))
- Severe metabolic disturbance occurrence(Day 2)