Hemodynamic and Respiratory Tolerance of Intermittent Hemodialysis in Critically Ill Patients (COOBrA)

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Other: Collection of clinical and biological data during renal replacement therapy sessions

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.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

• Study Contact: Name: Stanislas Faguer, MD; Phone Number: +33 05 61 32 24 75; Email: faguer.s@chu-toulouse.fr

Study Locations

• France
  • Toulouse, France, 31400
    • Hopital Rangueil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with acute kidney injury

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).	Other: 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).
Patients with acetate free biofiltration dialysis; 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; 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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Stanislas Faguer, MD

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2020
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: May 29, 2020
• First Submitted That Met QC Criteria: June 22, 2020
• First Posted (Actual): June 24, 2020

Study Record Updates

• Last Update Posted (Actual): July 28, 2023
• Last Update Submitted That Met QC Criteria: July 27, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: intensive care unit; critical care; Acute kidney injury; renal replacement therapy; acetate free biofiltration; bicarbonate-based hemodialysis; C02 removal
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Acute Kidney Injury
• Other Study ID Numbers: RC31/19/0496

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No