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

Hemodynamic and Respiratory Tolerance of Intermittent Hemodialysis in Critically Ill Patients

Sponsors

Lead sponsor: University Hospital, Toulouse

Source University Hospital, Toulouse
Brief Summary

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

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.

Overall Status Not yet recruiting
Start Date July 2020
Completion Date November 2021
Primary Completion Date November 2021
Study Type Observational
Primary Outcome
Measure Time Frame
Occurence of hemodynamic event From admission to discharge, up to 4 hours
Secondary Outcome
Measure Time Frame
Change in maximal PaCO2 1 hour after the beginning of dialysis , up to 4 hours
Maximum difference of tcPCO2 and etCO2 From admission to discharge, up to 4 hours
Change in the "strong ion difference" baseline, 4 hours
Change in plasma pH 1 hour after the beginning of dialysis session, up to 4 hours
Enrollment 200
Condition
Intervention

Intervention type: Other

Intervention name: Collection of clinical and biological data during renal replacement therapy sessions

Description: 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).

Eligibility

Sampling method: Non-Probability Sample

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role
Stanislas Faguer, MD Principal Investigator
Overall Contact

Last name: Stanislas Faguer, MD

Phone: 05 61 32 24 75

Phone ext: +33

Email: [email protected]

Location
facility contact Hôpital Rangueil Stanislas Faguer, MD 05 61 32 24 75 +33 [email protected]
Location Countries

France

Verification Date

June 2020

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Patients with bicarbonate-based intermittent dialysis

Description: 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).

Arm group label: Patients with acetate free biofiltration dialysis

Description: Acetate free biofiltration (AFB-K)is a technique that does not require dialysate acidification

Acronym COOBrA
Study Design Info

Observational model: Case-Only

Time perspective: Prospective

Source: ClinicalTrials.gov