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Safety and Efficacy of Intermittent Renal Replacement Therapy Using CITRASATE in Critically-ill Patients

Safety and Efficacy of Intermittent Renal Replacement Therapy Using CITRASATE in Critically-ill Patients: A Retrospective Series

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05313230
Acronym
CITRA-SAFE
Enrollment
61
Registered
2022-04-06
Start date
2022-02-01
Completion date
2022-06-30
Last updated
2022-04-06

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

Conditions

Acute Kidney Injury, Chronic Kidney Infection

Keywords

Renal Replacement Therapy, CITRASATE

Brief summary

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.

Detailed 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.

Interventions

OTHERCITRASATE SLED

Applying of CITRASATE SLED

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

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

Inclusion criteria

* Age ≥18 years * Patient underwent a RRT in the DAR Lapeyronie (CHU Montpellier) between the 01/01/2019 and the 31/12/2021

Exclusion criteria

* Patient underwent RRT without CITRASATE® protocol * Lack of data * Ethical limitation

Design outcomes

Primary

MeasureTime frameDescription
change of blood ionized calcium level disordersbaseline, per dialysis sessionRetrospective assessment of 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.

Secondary

MeasureTime frameDescription
Description of therapeutic consequences requiredday 1therapeutic consequences required in order to treat the ionized calcium troubles
Description of Clotting eventday 1the efficacy of CITRASATE® with our restitution protocol during RRT absence
Description of Dialysis doseday 1the efficacy of CITRASATE® with our restitution protocol during RRT (optimal dialysis dose)

Countries

France

Contacts

Primary ContactJonathan CHARBIT, MD
j-charbit@chu-montpellier.fr467338256

Outcome results

None listed

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