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Hemodynamic and Respiratory Tolerance of Intermittent Hemodialysis in Critically Ill Patients

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04444765
Acronym
COOBrA
Enrollment
200
Registered
2020-06-24
Start date
2020-04-23
Completion date
2022-12-31
Last updated
2023-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury

Keywords

Acute kidney injury, renal replacement therapy, acetate free biofiltration, bicarbonate-based hemodialysis, C02 removal, intensive care unit, critical care

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.

Interventions

OTHERCollection 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).

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Occurence of hemodynamic eventFrom admission to discharge, up to 4 hoursThe 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

MeasureTime frameDescription
Change in maximal PaCO21 hour after the beginning of dialysis , up to 4 hoursEvaluation of PaCO2 by arterial blood gas test
Maximum difference of tcPCO2 and etCO2From admission to discharge, up to 4 hoursEvaluation of TcPCO2 and etCO2 by trans-cutaneous measurement
Change in the strong ion differencebaseline, 4 hoursEvaluation of the strong ion difference by blood ionogram
Change in plasma pH1 hour after the beginning of dialysis session, up to 4 hoursEvaluation of plasma pH by blood ionogram

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026