Hemodynamic and Respiratory Tolerance of Intermittent Hemodialysis in Critically Ill Patients

Study Overview
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Brief Summary
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Acute kidney injury (AKI) affects up to 30% of critically ill patients and is associated with increased rates of mortality. Up to 60% of patients with AKI will ultimately require renal replacement therapy (RRT). Intermittent hemodialysis (IHD) is one of the main methods of RRT worldwide. In IHD-bicar, dialysate is composed by electrolytes, including calcium, and bicarbonate. To avoid calcium carbonate precipitation, dialysate has to be supplemented with acids (citric acid, chloride acid or acetic acid). However, IHD-bicar may be associated with hemodynamic instability or respiratory intolerance, mainly related to the CO2 release in the circulation during IHD (HCO3- <--> CO2 + H2O). Some recent studies showed that acetate free biofiltration (AFB-K), a technique that does not require dialysate acidification, could be associated with better hemodynamic stability and to a lower amount of CO2 delivered to the patients. AFB-K may thus improve the hemodynamic and respiratory tolerance of intermittent RRT in critically ill patients.

Detailed Description
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In this prospective observational study, investigators aim to characterize the hemodynamic and respiratory tolerances of HDI-bicar and AFB-K in critically ill patients requiring RRT.

Official Title
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Hemodynamic and Respiratory Tolerance of Intermittent Hemodialysis (Acetate Free Biofiltration and Bicarbonate-based Intermittent Dialysis) in Critically Ill Patients

Conditions
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Acute Kidney Injury

Intervention / Treatment
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* Other: Collection of clinical and biological data during renal replacement therapy sessions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥ 18 years old Invasive monitoring of blood pressure Non opposition to the research Admission to the intensive care unit Need of intermittent hemodialysis Exclusion Criteria: Sodium bicarbonate infusion Pregnancy or breastfeeding Juridical protection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with bicarbonate-based intermittent dialysis<br>Dialysate is composed by electrolytes, including calcium, and bicarbonate. To avoid calcium carbonate precipitation, dialysate has to be supplemented with acids (citric acid, chloride acid or acetic acid). | Other: Collection of clinical and biological data during renal replacement therapy sessions<br>* Collection of clinical and biological data during renal replacement therapy sessions. Two additional blood samples collected during and after RRT session (critically ill patients all have arterial catheter thus additional samples will not need additional puncture).<br>|
| Patients with acetate free biofiltration dialysis<br>Acetate free biofiltration (AFB-K)is a technique that does not require dialysate acidification | Other: Collection of clinical and biological data during renal replacement therapy sessions<br>* Collection of clinical and biological data during renal replacement therapy sessions. Two additional blood samples collected during and after RRT session (critically ill patients all have arterial catheter thus additional samples will not need additional puncture).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of hemodynamic event | The occurrence of at least one of the following events will be considered a hemodynamic event : Hypotension (decrease of systolic or mean blood pressures ≥ 15 and ≥ 10% respectively) Tachycardia (increase of heart beating ≥ 20%) Cardiac arrythmia (junctional tachycardia, atrial fibrillation, flutter, ventricular tachycardia or fibrillation) Decrease of the cardiac output ≥ 15% (only in patients with invasive cardiac output monitoring) Starting (or increase dosing) of norepinephrine ≥ 0.1 µg/kg/min | From admission to discharge, up to 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in maximal PaCO2 | Evaluation of PaCO2 by arterial blood gas test | 1 hour after the beginning of dialysis , up to 4 hours | 
| Maximum difference of tcPCO2 and etCO2 | Evaluation of TcPCO2 and etCO2 by trans-cutaneous measurement | From admission to discharge, up to 4 hours | 
| Change in the strong ion difference | Evaluation of the strong ion difference by blood ionogram | baseline, 4 hours | 
| Change in plasma pH | Evaluation of plasma pH by blood ionogram | 1 hour after the beginning of dialysis session, up to 4 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute kidney injury, renal replacement therapy, acetate free biofiltration, bicarbonate-based hemodialysis, C02 removal, intensive care unit, critical care