Hemodynamic and Respiratory Tolerance of Intermittent Hemodialysis in Critically Ill Patients

Acute Kidney Injury Clinical Trial

— COOBrA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04444765
• Other study ID #: RC31/19/0496
• Status: Completed
• Start date: April 23, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2023
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

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).

Locations

Country	Name	City	State
France	Hôpital Rangueil	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

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