Safety and Efficacy of Intermittent Renal Replacement Therapy Using CITRASATE in Critically-ill Patients (CITRA-SAFE)

University Hospital Center (CHU)

Status

Unknown

Conditions

Chronic Kidney Infection

Acute Kidney Injury

Treatments

Other: CITRASATE SLED

Study type

Observational

Funder types

Other

Identifiers

NCT05313230

RECHMPL21_0739

Details and patient eligibility

About

Renal Replacement Therapy (RRT) needs an extracorporeal circulation to conduct blood to the dialysis membrane and driving back to the patient. This extracorporeal circulation induces inevitably a risk of coagulation activation and premature clotting of the circuit. Heparin is thereby commonly used to prevent such thrombosis but exposed patient to risk of hemorrhage. This risk of hemorrhage may be important in ICU population, particularly in severe trauma patients.

The calcium is an important determinant of coagulation cascade. The use of specific citrate enriched dialysate without calcium (CITRASATE®) allows to suddenly lower the calcium concentration in extracorporeal plasma, leading to a regional ineffectiveness of clotting and limited heparin needs. This low calcium plasmatic concentration into the extracorporeal circulation has however to be normalized to not generate a systemic hypocalcemia. In our ICU, a local calcium substitution protocol based on dialysate flow is used in clinical practice.

Commonly used in our unit, there is a lack data to evaluate the CITRASATE dialysate in a critical population.

The aim goal of our study will be to assess safety and efficacy of intermittent renal replacement therapy using CITRASATE® in critically-ill patients.

Full description

This is a retrospective descriptive study. The included patients will be those who had a Sustained Low Efficiency Dialysis using CITRASATE® dialysate in CHU Lapeyronie in Montpellier, France between 01/01/2019 and 31/12/2021 Using PMSI code, we estimate that 61 patients could be enrolled in this period and each patient could be almost 6 dialysis session. We estimate we could analyzed 300 to 350 sessions. This sample must be confirmed by the opening of medical records.

A data collection will be focused on the RRT parameters, clinical complications until ICU discharge and outcome, extracted from medical records.

The main endpoint will be to determine the prevalence of ionized calcium troubles (hypocalcemia <0,8 mmol/L or Hypercalcemia >1,4 mmol/L) per and post dialysis using CITRASATE® with our restitution protocol, and their therapeutic consequences.

The secondary endpoints will be to describe the efficacy of CITRASATE® with our restitution protocol during RRT meant by an optimal dialysis dose and the absence of premature clotting of the circuit.

Enrollment

61 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria