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

Acute Kidney Injury Clinical Trial

— CITRA-SAFE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05313230
• Other study ID #: RECHMPL21_0739
• Status: Recruiting
• Start date: February 1, 2022
• Est. completion date: June 30, 2022

Study information

• Verified date: March 2022
• Source: University Hospital, Montpellier
• Contact: Jonathan CHARBIT, MD
• Phone: 467338256
• Email: j-charbit[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 61
• Est. completion date: June 30, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Other:
• CITRASATE SLED
Applying of CITRASATE SLED

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier	Montepllier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of blood ionized calcium level disorders	Retrospective 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.	baseline, per dialysis session
Primary	change of blood ionized calcium level disorders	Retrospective 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.	Day 1 (post dialysis session)
Secondary	Description of therapeutic consequences required	therapeutic consequences required in order to treat the ionized calcium troubles	day 1
Secondary	Description of Clotting event	the efficacy of CITRASATE® with our restitution protocol during RRT absence	day 1
Secondary	Description of Dialysis dose	the efficacy of CITRASATE® with our restitution protocol during RRT (optimal dialysis dose)	day 1