Hemodynamic and Respiratory Tolerance of Intermittent Hemodialysis in Critically Ill Patients

NCT04444765 | Completed

• 1 other identifier: RC31/19/0496
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in maximal PaCO2

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

• Maximum difference of tcPCO2 and etCO2

  From admission to discharge, up to 4 hours

• Change in the "strong ion difference"

  baseline, 4 hours

• Change in plasma pH

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

Study Arms (2)

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

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

Interventions

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).

Patients with acetate free biofiltration dialysis; Patients with bicarbonate-based intermittent dialysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with acute kidney injury

You may qualify if:

• Patients ≥ 18 years old
• Invasive monitoring of blood pressure
• Non opposition to the research
• Admission to the intensive care unit
• Need of intermittent hemodialysis

You may not qualify if:

• Sodium bicarbonate infusion
• Pregnancy or breastfeeding
• Juridical protection

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Hôpital Rangueil

Toulouse, 31400, France

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Stanislas Faguer, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 24, 2020
• Study Start: April 23, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: July 28, 2023

Record last verified: 2023-07

Locations

FR (1)