Hemodynamic and Respiratory Tolerance of Intermittent Hemodialysis in Critically Ill Patients

Completed

• Conditions: Acute Kidney Injury

• Registration Number: NCT04444765
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2020-04-23
• Study First Submitted: 2020-05-29
• Study First Submitted QC: 2020-06-22
• Study First Posted: 2020-06-24
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-27
• Last Update Posted: 2023-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurence of hemodynamic event	From admission to discharge, up to 4 hours	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hôpital Rangueil; 🇫🇷 Toulouse, France