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Completed

NCT Number: NCT04444765

Hemodynamic and Respiratory Tolerance of Intermittent Hemodialysis 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.

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Rangueil

Toulouse, 31400, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collection of clinical and biological data during renal replacement therapy sessions

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).

Primary outcomes

  1. Occurence of hemodynamic event

    Time frame: 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 outcomes

  1. Change in maximal PaCO2

    Time frame: 1 hour after the beginning of dialysis , up to 4 hours

    Evaluation of PaCO2 by arterial blood gas test

  2. Maximum difference of tcPCO2 and etCO2

    Time frame: From admission to discharge, up to 4 hours

    Evaluation of TcPCO2 and etCO2 by trans-cutaneous measurement

  3. Change in the "strong ion difference"

    Time frame: baseline, 4 hours

    Evaluation of the "strong ion difference" by blood ionogram

  4. Change in plasma pH

    Time frame: 1 hour after the beginning of dialysis session, up to 4 hours

    Evaluation of plasma pH by blood ionogram

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: COOBrA

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 24, 2020
Registry last updated
Jul 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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