Hemodynamic and Respiratory Tolerance of Intermittent Hemodialysis in Critically Ill Patients

NCT ID: NCT04444765

Last Updated: 2023-07-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-23
• Study Completion Date: 2022-12-31

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.

Conditions

Acute Kidney Injury

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with bicarbonate-based intermittent dialysis

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).

Collection of clinical and biological data during renal replacement therapy sessions

Intervention Type: OTHER

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).

Patients with acetate free biofiltration dialysis

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

Collection of clinical and biological data during renal replacement therapy sessions

Intervention Type: OTHER

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).

Interventions

Collection of clinical and biological data during renal replacement therapy sessions

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).

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stanislas Faguer, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

Hôpital Rangueil

Toulouse, , France

Countries

France

Other Identifiers

RC31/19/0496

Identifier Type: -

Identifier Source: org_study_id